Linking Marketplace Heparin Product Attributes and Manufacturing Processes to Bioactivity and Immunogenicity, 36786-36787 [2013-14579]

Download as PDF 36786 Federal Register / Vol. 78, No. 118 / Wednesday, June 19, 2013 / Notices if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202– 395–7285, Email: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2013–14589 Filed 6–18–13; 8:45 am] BILLING CODE 4184–01–P Food and Drug Administration [Docket No. FDA–2013–N–0012] Linking Marketplace Heparin Product Attributes and Manufacturing Processes to Bioactivity and Immunogenicity Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a sole source award to the University of North Carolina. The goal of the award is to identify what component(s) of the complex heparin mixtures have the propensity to cause heparin induced thrombocytopenia (HIT) to improve the safety of heparin drug products. The FDA seeks to identify the components of the heparin mixture that are associated with HIT so that actions may be taken to reduce these events and improve patient outcomes with this widely used drug. DATES: Important dates are as follows: 1. The application due date is July 15, 2013. 2. The anticipated start date is August, 2013. 3. The opening date is the date this announcement is published in the Federal Register. 4. The expiration date is July 16, 2013. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: Submit the paper application to: Gladys Melendez at the Food and Drug Administration, Grants Management (HFA–500), 5630 Fishers Lane, Rockville, MD 20857. For more information, see section III of the SUPPLEMENTARY INFORMATION section of this notice. ADDRESSES: VerDate Mar<15>2010 17:13 Jun 18, 2013 Jkt 229001 David Keire, Center for Drug Evaluation and Research, Food and Drug Administration, 1114 Market St., rm. 1002, St Louis, MO, 63130, 314–539– 3850; or Gladys Melendez, Office of Acquisition Support and Grant Services, Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 20857, 301–827–7175, email: Gladys.bohler@fda.hhs.gov. For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please contact Gladys.bohler @fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Funding Opportunity Description Request for Application: FDA RFA– 13–007 [Catalog of Federal Domestic Assistance: 93.103] DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: FOR FURTHER INFORMATION CONTACT: A. Background The goal of this Research Project is to identify which components of heparin drug mixtures have the propensity to cause heparin induced thrombocytopenia (HIT) in order to improve the safety profile of this widely used anticoagulant. Heparin is a heterogeneous mixture of polysaccharides of varying length, sulfation pattern, acylation and conformation that has been in clinical use since the 1930s. HIT is a drugdependent immune disorder caused by antibodies to complexes formed between platelet factor 4 (PF4) and heparin which can occur in patients who undergo major trauma (e.g. broken bones and cardiovascular surgery) and receive heparin. The condition leads to formation of abnormal blood clots and concomitant complications associated with clots. PF4-heparin antibodies are observed in all patients with HIT. In addition, low molecular weight heparins or the synthetic pentasaccharide (fondaparinux) have also been shown to cause HIT antibody formation although these smaller chain length heparins are much less likely to lead to clinical HIT symptoms. The major limitation in the available reagents for studies aimed at identifying the components of heparin that lead to the pathogenesis of HIT is the lack of pure component heparin standards. Therefore, this collaboration brings together the following capabilities and laboratories: (1) Synthesis of heparin chains of the same length, sulfation pattern and conformation (Dr. Liu at the University of North Carolina and Dr. Linhardt at Rensselaer Polytechnical Institute), (2) synthesis and physicochemical characterization of heparin and heparin-PF4 complexes PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 (Keire FDA/DPA St Louis) and (3) a HIT-immunogenicity animal model (Dr. Arepally at Duke University). FDA believes that this combination of skills and expertise has the potential to make pure standards, fully characterize the standards, create and characterize PF4heparin standard aggregates and assess their propensity to elicit an immune response in an animal model. This research is unique and not otherwise available. The ability to make pure heparin standards in gram quantities and fully characterize their properties is only available from the Liu and Linhardt laboratories. Furthermore, Dr. Arepally’s mouse model of HIT immunogenicity is not available in any other laboratory. When completed the study will identify heparin components that enhance HIT propensity and which could potentially be minimized in heparin manufacturing, leading to safer heparin drugs with better patient outcomes. B. Research Objectives The research objective is to identify the components of the heparin mixture that have the propensity to lead to HIT pathogenesis. C. Eligibility Information This is a sole source RFA because the investigators identified in this document have unique skills and expertise necessary to perform the proposed work. II. Award Information/Funds Available A. Award Amount Only one award will be available to the University of North Carolina in the amount of $250,000 (Total Cost) in the first year. B. Length of Support Depending on research progress and subject to the availability of funds additional funds may be awarded under this grant for up to a five year project period reflecting $250,000 Total Cost per year. III. Paper Application, Registration, and Submission Information To submit a paper application in response to this FOA, applicants should first review the full announcement. Persons interested in applying for a grant may obtain an application at https://grants.nih.gov/grants/forms.htm. For all paper application submissions, the following steps are required: • Step 1: Obtain a Dun and Bradstreet (DUNS) Number • Step 2: Register With Central Contractor Registration E:\FR\FM\19JNN1.SGM 19JNN1 Federal Register / Vol. 78, No. 118 / Wednesday, June 19, 2013 / Notices • Step 3: Register With Electronic Research Administration (eRA) Commons Steps 1 and 2, in detail, can be found at https://www07.grants.gov/applicants/ organization_registration.jsp. Step 3, in detail, can be found at https:// commons.era.nih.gov/commons/ registration/registrationInstructions.jsp. After you have followed these steps, submit paper applications to: Gladys Melendez; Grants Management, Food and Drug Administration, 5630 Fishers Lane, rm. 2032; HFA–500; Rockville, MD 20857. Dated: June 12, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–14579 Filed 6–18–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. mstockstill on DSK4VPTVN1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on August 5, 2013, from 8 a.m. to 5:30 p.m. Location: FDA White Oak Campus, Building 31, the Great Room, White Oak Conference Center (Rm. 1503), 10903 New Hampshire Ave., Silver Spring, MD 20993–0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/Advisory Committees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Kristina Toliver, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire VerDate Mar<15>2010 17:13 Jun 18, 2013 Jkt 229001 Ave., WO31–2417, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301– 847–8533, email: CRDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On August 5, 2013, the committee will discuss new drug application (NDA) 204441, tolvaptan tablets, submitted by Otsuka Pharmaceutical Company, Ltd., for the proposed indication of slowing kidney disease in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (autosomal dominant polycystic kidney disease is a genetic disease that affects the kidney and can lead to kidney failure). FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before July 22, 2013. Oral presentations from the public will be scheduled between approximately 1 p.m. to 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before July 12, 2013. Time allotted for each presentation may be limited. If the number of registrants requesting to PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 36787 speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by July 15, 2013. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Kristina Toliver at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: June 14, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2013–14632 Filed 6–18–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development Without the Thorough QT Study; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), the Cardiac Safety Research Consortium, and the International Life Sciences Institute’s Health and Environmental Sciences Institute (HESI) will cosponsor a public workshop entitled ‘‘Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development Without the Thorough QT Study.’’ The workshop will introduce for discussion a new E:\FR\FM\19JNN1.SGM 19JNN1

Agencies

[Federal Register Volume 78, Number 118 (Wednesday, June 19, 2013)]
[Notices]
[Pages 36786-36787]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14579]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0012]


Linking Marketplace Heparin Product Attributes and Manufacturing 
Processes to Bioactivity and Immunogenicity

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 a sole source award to 
the University of North Carolina. The goal of the award is to identify 
what component(s) of the complex heparin mixtures have the propensity 
to cause heparin induced thrombocytopenia (HIT) to improve the safety 
of heparin drug products. The FDA seeks to identify the components of 
the heparin mixture that are associated with HIT so that actions may be 
taken to reduce these events and improve patient outcomes with this 
widely used drug.

DATES: Important dates are as follows:
    1. The application due date is July 15, 2013.
    2. The anticipated start date is August, 2013.
    3. The opening date is the date this announcement is published in 
the Federal Register.
    4. The expiration date is July 16, 2013.

ADDRESSES: Submit the paper application to: Gladys Melendez at the Food 
and Drug Administration, Grants Management (HFA-500), 5630 Fishers 
Lane, Rockville, MD 20857. For more information, see section III of the 
SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: David Keire, Center for Drug 
Evaluation and Research, Food and Drug Administration, 1114 Market St., 
rm. 1002, St Louis, MO, 63130, 314-539-3850; or Gladys Melendez, Office 
of Acquisition Support and Grant Services, Food and Drug 
Administration, 5630 Fishers Lane, Rockville, MD 20857, 301-827-7175, 
email: Gladys.bohler@fda.hhs.gov.
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please contact Gladys.bohler@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

    Request for Application: FDA RFA-13-007
    [Catalog of Federal Domestic Assistance: 93.103]

A. Background

    The goal of this Research Project is to identify which components 
of heparin drug mixtures have the propensity to cause heparin induced 
thrombocytopenia (HIT) in order to improve the safety profile of this 
widely used anticoagulant. Heparin is a heterogeneous mixture of 
polysaccharides of varying length, sulfation pattern, acylation and 
conformation that has been in clinical use since the 1930s. HIT is a 
drug-dependent immune disorder caused by antibodies to complexes formed 
between platelet factor 4 (PF4) and heparin which can occur in patients 
who undergo major trauma (e.g. broken bones and cardiovascular surgery) 
and receive heparin. The condition leads to formation of abnormal blood 
clots and concomitant complications associated with clots. PF4-heparin 
antibodies are observed in all patients with HIT. In addition, low 
molecular weight heparins or the synthetic pentasaccharide 
(fondaparinux) have also been shown to cause HIT antibody formation 
although these smaller chain length heparins are much less likely to 
lead to clinical HIT symptoms.
    The major limitation in the available reagents for studies aimed at 
identifying the components of heparin that lead to the pathogenesis of 
HIT is the lack of pure component heparin standards. Therefore, this 
collaboration brings together the following capabilities and 
laboratories: (1) Synthesis of heparin chains of the same length, 
sulfation pattern and conformation (Dr. Liu at the University of North 
Carolina and Dr. Linhardt at Rensselaer Polytechnical Institute), (2) 
synthesis and physicochemical characterization of heparin and heparin-
PF4 complexes (Keire FDA/DPA St Louis) and (3) a HIT-immunogenicity 
animal model (Dr. Arepally at Duke University). FDA believes that this 
combination of skills and expertise has the potential to make pure 
standards, fully characterize the standards, create and characterize 
PF4-heparin standard aggregates and assess their propensity to elicit 
an immune response in an animal model. This research is unique and not 
otherwise available. The ability to make pure heparin standards in gram 
quantities and fully characterize their properties is only available 
from the Liu and Linhardt laboratories. Furthermore, Dr. Arepally's 
mouse model of HIT immunogenicity is not available in any other 
laboratory. When completed the study will identify heparin components 
that enhance HIT propensity and which could potentially be minimized in 
heparin manufacturing, leading to safer heparin drugs with better 
patient outcomes.

B. Research Objectives

    The research objective is to identify the components of the heparin 
mixture that have the propensity to lead to HIT pathogenesis.

C. Eligibility Information

    This is a sole source RFA because the investigators identified in 
this document have unique skills and expertise necessary to perform the 
proposed work.

II. Award Information/Funds Available

A. Award Amount

    Only one award will be available to the University of North 
Carolina in the amount of $250,000 (Total Cost) in the first year.

B. Length of Support

    Depending on research progress and subject to the availability of 
funds additional funds may be awarded under this grant for up to a five 
year project period reflecting $250,000 Total Cost per year.

III. Paper Application, Registration, and Submission Information

    To submit a paper application in response to this FOA, applicants 
should first review the full announcement. Persons interested in 
applying for a grant may obtain an application at https://grants.nih.gov/grants/forms.htm.
    For all paper application submissions, the following steps are 
required:
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number
     Step 2: Register With Central Contractor Registration

[[Page 36787]]

     Step 3: Register With Electronic Research Administration 
(eRA) Commons
    Steps 1 and 2, in detail, can be found at https://www07.grants.gov/applicants/organization_registration.jsp. Step 3, in detail, can be 
found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps, 
submit paper applications to: Gladys Melendez; Grants Management, Food 
and Drug Administration, 5630 Fishers Lane, rm. 2032; HFA-500; 
Rockville, MD 20857.

    Dated: June 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14579 Filed 6-18-13; 8:45 am]
BILLING CODE 4160-01-P
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