Memorandum of Understanding Between the Food and Drug Administration and WebMD, LLC, 73941-73947 [E8-28690]

Download as PDF Federal Register / Vol. 73, No. 234 / Thursday, December 4, 2008 / Notices mstockstill on PROD1PC66 with NOTICES Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, or the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit written comments on the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Brenda R. Friend, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210; or David Cummings, Center for Drug Evaluation and Research (HFD–354), Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 21, rm. 3525, Silver Spring, MD 20993, 301– 796–2400. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled ‘‘Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics’’ dated November 2008. The guidance document provides information concerning the various cooperative manufacturing arrangements used in the production of biological products subject to licensure under section 351 of the PHS Act (42 U.S.C. 262). The guidance describes FDA’s current thinking on licensing strategies for meeting the increased need for planning flexible manufacturing arrangements. Because cooperative manufacturing arrangements can take a considerable amount of time to develop, the guidance may also be useful for planning purposes in the early phases of product development. Several types of manufacturing arrangements discussed in the guidance include short supply arrangements, divided manufacturing arrangements, shared manufacturing arrangements, and contract manufacturing arrangements. The guidance supersedes ‘‘FDA’s Policy Statement Concerning Cooperative Manufacturing Arrangements for VerDate Aug<31>2005 17:35 Dec 03, 2008 Jkt 217001 Licensed Biologics’’ published in the Federal Register of November 25, 1992 (57 FR 55544). In the Federal Register of August 3, 1999 (64 FR 42136), FDA announced the availability of the draft guidance of the same title dated August 1999. FDA received several comments on the draft guidance; those comments were considered as the guidance was finalized. In response to public comments, we clarified the document and reformatted it into plain language. In the Federal Register of July 23, 2007 (72 FR 40157), FDA published a 60-day notice requesting public comment on the information collections in the draft guidance of the same title dated July 2007, which revised the draft guidance dated August 1999. The guidance announced in this notice finalizes the draft guidance dated July 2007. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents FDA’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in this guidance were approved under OMB control number 0910–0629. III. Comments Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in the brackets in the heading of this document. A copy of the guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 73941 accepted by FDA only through FDMS at http://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either http:// www.fda.gov/cber/guidelines.htm or http://www.regulations.gov. Dated: November 24, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–28693 Filed 12–3–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0043] [FDA No. 225–08–8006] Memorandum of Understanding Between the Food and Drug Administration 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’s Office of External Relations and WebMD, LLC. The purpose of the MOU is to extend the reach of FDA Consumer Health Information and to provide consumers with better information and timely content concerning public health and safety topics, including alerts of emerging safety issues and product recalls. Specific elements of the MOU include the creation of an FDA/WebMD online resource on the WebMD.com site, which will feature editorial and visual FDA Consumer Health Information, and the inclusion of FDA Consumer Health Information in at least three issues per year of WebMD The Magazine. An agency policy statement summarizing the criteria and processes for development of this type of collaboration is available on FDA’s Web site at www.fda.gov/consumer/ co_brandpolicy.html. The agreement became effective October 10, 2008. FOR FURTHER INFORMATION CONTACT: Jason Brodsky, Director, Consumer Health Information Staff, Office of External Relations (HFI–40), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–6251 Nan Forte, Executive Vice President, DATES: E:\FR\FM\04DEN1.SGM 04DEN1 73942 Federal Register / Vol. 73, No. 234 / Thursday, December 4, 2008 / Notices mstockstill on PROD1PC66 with NOTICES WebMD, LLC, 111 8th Ave., 7th floor, New York, NY 10011, 212– 624–3821 SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), VerDate Aug<31>2005 17:35 Dec 03, 2008 Jkt 217001 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. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Dated: November 18, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. BILLING CODE 4160–01–S E:\FR\FM\04DEN1.SGM 04DEN1 VerDate Aug<31>2005 17:35 Dec 03, 2008 Jkt 217001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4725 E:\FR\FM\04DEN1.SGM 04DEN1 73943 EN04DE08.041</GPH> mstockstill on PROD1PC66 with NOTICES Federal Register / Vol. 73, No. 234 / Thursday, December 4, 2008 / Notices VerDate Aug<31>2005 Federal Register / Vol. 73, No. 234 / Thursday, December 4, 2008 / Notices 17:35 Dec 03, 2008 Jkt 217001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4725 E:\FR\FM\04DEN1.SGM 04DEN1 EN04DE08.042</GPH> mstockstill on PROD1PC66 with NOTICES 73944 VerDate Aug<31>2005 17:35 Dec 03, 2008 Jkt 217001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4725 E:\FR\FM\04DEN1.SGM 04DEN1 73945 EN04DE08.043</GPH> mstockstill on PROD1PC66 with NOTICES Federal Register / Vol. 73, No. 234 / Thursday, December 4, 2008 / Notices VerDate Aug<31>2005 Federal Register / Vol. 73, No. 234 / Thursday, December 4, 2008 / Notices 17:35 Dec 03, 2008 Jkt 217001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\04DEN1.SGM 04DEN1 EN04DE08.044</GPH> mstockstill on PROD1PC66 with NOTICES 73946 Federal Register / Vol. 73, No. 234 / Thursday, December 4, 2008 / Notices [FR Doc. E8–28690 Filed 12–3–08; 8:45 am] BILLING CODE 4160–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute of Mental Health; Notice of Meeting National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), 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(cX4) 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. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflicts: Musculoskeletal Rehabilitation Sciences. Date: December 9, 2008. Time: 12 p.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: John P. Holden, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4211, MSC 7814, Bethesda, MD 20892, 301–496– 8551, holdenjo@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. mstockstill on PROD1PC66 with NOTICES (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: November 25, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–28622 Filed 12–3–08; 8:45 am] BILLING CODE 4140–01–M VerDate Aug<31>2005 17:35 Dec 03, 2008 Jkt 217001 Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Services Subcommittee of the Interagency Autism Coordinating Committee (IACC). The purpose of the Services Subcommittee is to review the current state of services and supports for individuals with Autism Spectrum Disorder (ASD) and their families in order to improve these services. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the Contact Person listed below at least 5 business days in advance of the meeting. The Subcommittee will report on its meeting at the February meeting of the IACC. Name of Committee: Interagency Autism Coordinating Committee (IACC). Type of meeting: Services Subcommittee. Date: December 10, 2008. Time: 2 p.m. to 5:30 p.m. Eastern Time. Agenda: To review public comments received in response to a completed Request for Information from Autism Spectrum Disorders (ASD) stakeholders about what they consider to be high-priority issues and concerns surrounding services and supports for children, youth, and adults with ASD. Place: In Person: National Institutes of Health, 9000 Rockville Pike, Building 31C, Conference Room 7,Bethesda, MD 20892. Webinar: https://www1.gotomeeting.com/ register/563207085. To Access the Conference Call: Dial: 888–455–2920, Access code: 3857872. Contact Person: Ms. Lina Perez, Office of Autism Research Coordination, Office of the Director, National Institute of Mental Health, NIH, 6001 Executive Boulevard, NSC, Room 8204a, Bethesda, MD 20892–9669, 301–443– 6040, IACCPublicInquiries@mail.nih.gov. Please Note: The meeting will be open to the public with limited seating. In addition, the public can access the meeting through a conference call phone number and a Web presentation tool on the Internet. Individuals who participate using these electronic services and who need special assistance, such as captioning of the conference call or other reasonable accommodations, should submit a request at least 5 days prior to the meeting. Members of the public who participate using the conference call phone number will be able to listen to the meeting but will not be heard. There may be an opportunity for PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 73947 members of the public to submit written comments during the Subcommittee meeting through the Web presentation tool. Submitted comments will be reviewed after the meeting. If you experience any technical problems with the Web presentation tool, please contact GoToWebinar at (800) 263– 6317. To access the Web presentation tool on the Internet the following computer capabilities are required: (A) Internet Explorer 5.0 or later, Netscape Navigator 6.0 or later or Mozilla Firefox 1.0 or later; (B) Windows 2000, XP Home, XP Pro, 2003 Server or Vista; (C) Stable 56k, cable modem, ISDN, DSL or better Internet connection; (D) Minimum of Pentium 400 with 256 MB of RAM (Recommended); (E) Java Virtual Machine enabled (Recommended). This notice is being published less than 15 days prior to the meeting due to the urgency to review the public comments received in response to a completed Request for Information from Autism Spectrum Disorders stakeholders. Information about the IACC is available on the Web site: http://www.iacc.hhs.gov. Dated: November 26, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–28743 Filed 12–3–08; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Cancer Advisory Board, December 9, 2008, 8:30 a.m. to 3:55 p.m., National Institutes of Health, Building 31, 31 Center Drive, Bethesda, MD 20892, which was published in the Federal Register on November 24, 2008 73 FR 71015. This notice is amended to change the start time of the open session on December 9, 2008 to approximately 11:15 a.m. and the end time to 3:30 p.m. The closed session will be held from 3:30 p.m. to 3:55 p.m. Dated: November 25, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–28727 Filed 12–3–08; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\04DEN1.SGM 04DEN1

Agencies

[Federal Register Volume 73, Number 234 (Thursday, December 4, 2008)]
[Notices]
[Pages 73941-73947]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28690]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0043]
[FDA No. 225-08-8006]


Memorandum of Understanding Between the Food and Drug 
Administration 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's Office of External 
Relations and WebMD, LLC. The purpose of the MOU is to extend the reach 
of FDA Consumer Health Information and to provide consumers with better 
information and timely content concerning public health and safety 
topics, including alerts of emerging safety issues and product recalls.
    Specific elements of the MOU include the creation of an FDA/WebMD 
online resource on the WebMD.com site, which will feature editorial and 
visual FDA Consumer Health Information, and the inclusion of FDA 
Consumer Health Information in at least three issues per year of WebMD 
The Magazine.
    An agency policy statement summarizing the criteria and processes 
for development of this type of collaboration is available on FDA's Web 
site at www.fda.gov/consumer/co_brandpolicy.html.

DATES: The agreement became effective October 10, 2008.

FOR FURTHER INFORMATION CONTACT:
    Jason Brodsky, Director, Consumer Health Information Staff, Office 
of External Relations (HFI-40), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-6251
    Nan Forte, Executive Vice President,

[[Page 73942]]

WebMD, LLC, 111 8th Ave., 7th floor, New York, NY 10011, 212-624-3821

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: November 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
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