Memorandum of Understanding Between the Food and Drug Administration and MEDSCAPE, LLC and WEBMD LLC, 41267-41272 [2011-17565]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 134 / Wednesday, July 13, 2011 / Notices thus, the critical path pipeline. This research does not require clinical or animal studies. Instead, it will lead to the creation of materials with physical properties in materials that have been previously identified as being desirable. • Physical characteristics of active ingredients and recipients in drug products, such as crystal morphology, co-crystal technology, dispersions, and particle sizing including nanotechnology are not fully developed in the public sector. This work will develop technology enabling control of these attributes. This will provide another dimension of control to the predictability of pharmaceutical products. This added control will enable new approaches to manufacturing novel dosage forms and shorten the time it takes to develop manufacturing processes and controls. • Development of specialized manufacturing techniques suitable for products administered in low dosages and for products with high toxicity or narrow therapeutic ranges. This will enable more rapid development of manufacturing techniques for these products. • Development of models for manufacturing and engineering of device products such as infusion pumps, prosthetic organs, defibrillators, tissue engineering devices, and combination products will help standardize the approach for bringing these medical products to market. This includes development of components for more reliable delivery of pharmaceuticals to the most desirable site of action, for example, controlling the air plume of inhaled products. This will shorten the time required to move such products from concept to patient and thereby shorten the Industrialization sector of the Critical Path. • Research into methods for laboratory synthesis of molecules that have been designed by computer simulation will shorten medical product development time. These methods will make the creation of these molecules more predictable. These technologies will also enable new drug discoveries to be brought to market faster with less variability; higher predictability of performance. • Approaches to improve facilities where this research will be conducted. Advanced technology development can be accelerated by better design of the facilities where this research is conducted. Creating and making these designs public will have the effect of accelerating technology across the industry. This will shorten the time it takes to bring these advanced VerDate Mar<15>2010 17:36 Jul 12, 2011 Jkt 223001 technologies into the product manufacturing sector. C. Eligibility Information National Institute for Pharmaceutical Technology and Education Initiative (NIPTE), a Nonprofit Other Than Institutions of Higher Education, described in section 501(c)(3) of the Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3), which is exempt from tax under section 501(a) of that code. NIPTE is the only consortium of universities of its kind. The organization consists of many of the most highly qualified pharmaceutical manufacturing experts in academia. Research conducted by NIPTE Faculty is collaborative by design to provide for coordinated publication of the cuttingedge research results. An eligible organization that wishes to enter into a collaborative agreement must provide an assurance that the entity will not accept funding for a Critical Path Public-Private Partnership Project from any organization that manufactures or distributes products regulated by FDA unless the entity provides assurance in its agreement with FDA that the results of the Critical Path Public Partnership project will not be influenced by any source of funding. The entities eligible to enter into partnerships with FDA are governed by section 566 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb5). This cooperative agreement will provide continued support for established and previously funded collaborations on behalf of FDA priorities. 41267 FDA/CentersOffices/CDER/ ucm088761.htm located under the ‘‘Regulatory Information’’ section. The title of the page is ‘‘Research Acquisitions.’’ 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. • 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 Officer/ Grants Management Specialist (see For Further Information and Additional Requirements Contact). Dated: July 7, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–17515 Filed 7–12–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration II. Award Information/Funds Available [Docket No. FDA–2011–N–0005] A. Award Amount Only one grant will be awarded. In fiscal year 2011, there is currently $700,000 available. As funds are available, partner components may supplement up to $7,000,000 total cost per year, depending on the availability of fiscal year funds. Memorandum of Understanding Between the Food and Drug Administration and MEDSCAPE, LLC and WEBMD LLC B. Length of Support Application budgets are not limited, but need to reflect actual needs of the proposed project. This Cooperative Agreement is capable of awarding a total of $35,000,000 over the entire award project period depending upon progress, the need for, and the availability of fiscal year funds. III. Paper Application, Registration, and Submission Information To submit a paper application in response to this FOA, applicants should first review the full announcement located at https://www.fda.gov/About PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and MEDSCAPE, LLC AND WEBMD LLC. The purpose of the MOU is to complement FDA’s capacity to educate and communicate with health care professionals. It will also promote the timely dissemination to health care professionals of accurate information on public health and emerging safety issues and products safety recalls. DATES: The agreement became effective June 8, 2011. SUMMARY: FOR FURTHER INFORMATION CONTACT: E:\FR\FM\13JYN1.SGM 13JYN1 Federal Register / Vol. 76, No. 134 / Wednesday, July 13, 2011 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES Anna Fine, Office of Special Health Issues, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5337, Silver Spring, MD 20993– 0002, 301–796–8471, e-mail: Anna.Wojas@fda.hhs.gov. VerDate Mar<15>2010 17:36 Jul 12, 2011 Jkt 223001 In accordance with 21 CFR 20.108(c), which states that all written agreements and MOUs between FDA and others shall be published in the Federal SUPPLEMENTARY INFORMATION: PO 00000 Register, the Agency is publishing notice of this MOU. Dated: July 7, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. BILLING CODE 4160–01–P Frm 00083 Fmt 4703 Sfmt 4725 E:\FR\FM\13JYN1.SGM 13JYN1 EN13JY11.009</GPH> 41268 VerDate Mar<15>2010 17:36 Jul 12, 2011 Jkt 223001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4725 E:\FR\FM\13JYN1.SGM 13JYN1 41269 EN13JY11.010</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 134 / Wednesday, July 13, 2011 / Notices VerDate Mar<15>2010 Federal Register / Vol. 76, No. 134 / Wednesday, July 13, 2011 / Notices 17:36 Jul 12, 2011 Jkt 223001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4725 E:\FR\FM\13JYN1.SGM 13JYN1 EN13JY11.011</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 41270 VerDate Mar<15>2010 17:36 Jul 12, 2011 Jkt 223001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4725 E:\FR\FM\13JYN1.SGM 13JYN1 41271 EN13JY11.012</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 134 / Wednesday, July 13, 2011 / Notices 41272 [FR Doc. 2011–17565 Filed 7–12–11; 8:45 am] BILLING CODE 4160–01–C mstockstill on DSK4VPTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as VerDate Mar<15>2010 17:36 Jul 12, 2011 Jkt 223001 amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 Name of Commitee: National Institute of General Medical Sciences Special Emphasis Panel, K99 Pathway to Independence Grant Applications Review. Date: August 2, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015. Contact Person: John J. Laffan, PhD, Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3AN18J, Bethesda, MD E:\FR\FM\13JYN1.SGM 13JYN1 EN13JY11.013</GPH> Federal Register / Vol. 76, No. 134 / Wednesday, July 13, 2011 / Notices

Agencies

[Federal Register Volume 76, Number 134 (Wednesday, July 13, 2011)]
[Notices]
[Pages 41267-41272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17565]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0005]


Memorandum of Understanding Between the Food and Drug 
Administration and MEDSCAPE, LLC and WEBMD LLC

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
a memorandum of understanding (MOU) between FDA and MEDSCAPE, LLC AND 
WEBMD LLC. The purpose of the MOU is to complement FDA's capacity to 
educate and communicate with health care professionals. It will also 
promote the timely dissemination to health care professionals of 
accurate information on public health and emerging safety issues and 
products safety recalls.

DATES: The agreement became effective June 8, 2011.

FOR FURTHER INFORMATION CONTACT: 

[[Page 41268]]

    Anna Fine, Office of Special Health Issues, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5337, Silver 
Spring, MD 20993-0002, 301-796-8471, e-mail: Anna.Wojas@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and MOUs between FDA and others 
shall be published in the Federal Register, the Agency is publishing 
notice of this MOU.

    Dated: July 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
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[FR Doc. 2011-17565 Filed 7-12-11; 8:45 am]
BILLING CODE 4160-01-C

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