National Institute on Deafness and Other Communication Disorders Notice of Closed Meetings, 8887-8888 [2012-3569]

Download as PDF Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices Location: The public workshop will be held at the Marriott Ann Arbor Ypsilanti at Eagle Crest, 1275 S. Huron St., Ypsilanti, MI 48197, 800–606–7044. Contact: Society of Clinical Research Associates (SoCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914, 1–800–762–7292 or 215–822–8644, FAX: 215–822–8633, email: SoCRAmail@aol.com, Web site: https:// www.SoCRA.org. (FDA has verified the Web site addresses throughout this document, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.); or Nancy Bellamy, Food and Drug Administration, Detroit District Office, 300 River Pl., Suite 5900, Detroit, MI 48207, 313–393–8143, Fax: 313–393– 8139, email: nancy.bellamy@fda.hhs.gov. Accommodations: Attendees are responsible for their own accommodations. Please mention SoCRA to receive the hotel room rate of $119 plus applicable taxes (available until April 17, 2012 or until the SoCRA room block is filled). COST OF REGISTRATION SoCRA member ....................... SoCRA nonmember (includes membership) ......................... Federal Government member .. Federal Government nonmember ................................. FDA Employee ......................... $575 650 450 525 * sroberts on DSK5SPTVN1PROD with NOTICES * (Free) Fee Waived. If you need special accommodations due to a disability, please contact SoCRA (see Contact) at least 21 days in advance. Extended periods of question and answer and discussion have been included in the program schedule. SoCRA designates this educational activity for a maximum of 13.3 Continuing Education Credits for SoCRA CE and Nurse CNE. SoCRA designates this live activity for a maximum of 13.3 AMA PRA Category 1 Credit(s) TM. Physicians should claim only the credit commensurate with the extent of their participation. CME for Physicians: SoCRA is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. CNE for Nurses: SoCRA is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association (PSNA), an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation (ANCC). ANCC/PSNA Provider Reference Number: 205–3–A–09. VerDate Mar<15>2010 17:09 Feb 14, 2012 Jkt 226001 8887 Registration Instructions: To register, please submit a registration form with your name, affiliation, mailing address, telephone, fax number, and email, along with a check or money order payable to ‘‘SoCRA’’. Mail to: SoCRA (see Contact for address). To register via the Internet, go to https://www.socra.org/html/ FDA_Conference.htm. Payment by major credit card is accepted (Visa/ MasterCard/AMEX only). For more information on the meeting registration, or for questions on the workshop, contact SoCRA (see Contact). Dated: February 9, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. The public workshop helps fulfill the Department of Health and Human Services’ and FDA’s important mission to protect the public health. The workshop will provide those engaged in FDA-regulated (human) clinical trials with information on a number of topics concerning FDA requirements related to informed consent, clinical investigation requirements, IRB inspections, electronic record requirements, and investigator initiated research. Topics for discussion include the following: (1) What FDA Expects in a Pharmaceutical Clinical Trial; (2) Adverse Event Reporting—Science, Regulation, Error, and Safety; (3) Part 11 Compliance— Electronic Signatures; (4) Informed Consent Regulations; (5) IRB Regulations and FDA Inspections; (6) Keeping Informed and Working Together; (7) FDA Conduct of Clinical Investigator Inspections; (8) Meetings With FDA: Why, When, and How; (9) Investigator Initiated Research; (10) Medical Device Aspects of Clinical Research; (11) Working With FDA’s Center for Biologics Evaluation and Research; (12) The Inspection is Over— What Happens Next? Possible FDA Compliance Actions; (13) Ethical Issues in Subject Enrollment; (14) Medical Device Aspects of Clinical Research; (15) Are We There Yet? An Overview of the FDA GCP Program. FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The public workshop helps to achieve objectives set forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393) which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The public workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121) as outreach activities by Government Agencies to small businesses. Pursuant to the Federal Advisory Committee Act, as amended (5 U.S.C. App), the Director, National Institutes of Health (NIH), announces the establishment of the National Center for Advancing Translational Sciences Advisory Council (Council) and the Cures Acceleration Network Review Board (Board), in the National Center for Advancing Translation Sciences (NCATS). The Council will advise, assist, consult with, and make recommendations to the Secretary of Health and Human Services (Secretary), the Director, National Institutes of Health (NIH) and the Director, National Center for Advancing Translational Sciences (NCATS, also referred to as Center) on matters related to the activities carried out by and through the Center and the policies respecting these activities. The Board will advise, and provide recommendation to, the Director, NCATS, with respect to (1) policies, programs, and procedures for carrying out the duties of the Director, NCATS, under section 480 of the PHS Act; and (2) significant barriers to successful translation of basic science into clinical application (including issues under the purview of other agencies and departments). Duration of each committee is two years from the date the Charter is filed. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 [FR Doc. 2012–3553 Filed 2–14–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director Notice of Establishment Dated: February 7, 2012. Francis S. Collins, Director, National Institutes of Health. [FR Doc. 2012–3572 Filed 2–14–12; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Deafness and Other Communication Disorders Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as E:\FR\FM\15FEN1.SGM 15FEN1 8888 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices sroberts on DSK5SPTVN1PROD with NOTICES amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings 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. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; Outcome of Cochlear Implants. Date: March 1, 2012. Time: 9 a.m. to 10:30 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6120 Executive Blvd., Rockville, MD 20852 (Telephone Conference Call). Contact Person: Shiguang Yang, DVM, Ph.D., Scientific Review Officer, Division of Extramural Activities, NIDCD, NIH, 6120 Executive Blvd., Bethesda, MD 20892, 301– 496–8683. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; H & B Small Grants. Date: March 7, 2012. Time: 12 p.m. to 3 p.m.. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6120 Executive Blvd. Rockville, MD 20852 (Telephone Conference Call). Contact Person: Sheo Singh, Ph.D. Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, Executive Plaza South, Room 400C, 6120 Executive Blvd., Bethesda, MD 20892, 301– 496–8683, singhs@nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders; Special Emphasis Panel; R03–VSL. Date: March 8, 2012. Time: 11 a.m. to 1 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6120 Executive Blvd., Rockville, MD 20852, (Telephone Conference Call). Contact Person: Christine A. Livingston, Ph.D., Scientific Review Officer Division of Extramural Activities, National Institutes of Health/NIDCD, 6120 Executive Blvd.—MSC 7180, Bethesda, MD 20892 (301) 496–8683, livingsc@mail.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; R03 Chemosensory. Date: March 9, 2012. Time: 11 a.m. to 1 p.m.. Agenda: To review and evaluate grant applications. VerDate Mar<15>2010 17:09 Feb 14, 2012 Jkt 226001 Place: National Institutes of Health, 6120 Executive Blvd., Rockville, MD 20852, (Telephone Conference Call). Contact Person: Kausik Ray, Ph.D., Scientific Review Officer, National Institute on Deafness and Other Communication Disorders, National Institutes of Health, Rockville, MD 20850, 301–402–3587, rayk@nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; Clinical Trial Review. Date: March 13, 2012. Time: 11 a.m. to 1 p.m.. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6120 Executive Blvd., Rockville, MD 20852, (Telephone Conference Call). Contact Person: Christine A. Livingston, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institutes of Health/NIDCD, 6120 Executive Blvd.—MSC 7180, Bethesda, MD 20892, (301) 496–8683, livingsc@mail.nih.gov. Information is also available on the Institute’s/Center’s home page: https:// www.nidcd.nih.gov/about/groups/sep/, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.173, Biological Research Related to Deafness and Communicative Disorders, National Institutes of Health, HHS) Dated: February 9, 2012. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2012–3569 Filed 2–14–12; 8:45 am] Disorders Special Emphasis Panel, Clinical Trial Review. Date: February 21, 2012. Time: 11 a.m. to 1 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6120 Executive Blvd., Rockville, MD 20852 (Telephone Conference Call). Contact Person: Christine A. Livingston, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institutes of Health/NIDCD, 6120 Executive Blvd.—MSC 7180, Bethesda, MD 20892, (301) 496–8683 livingsc@mail.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. Information is also available on the Institute’s/Center’s home page: https:// www.nidcd.nih.gov/about/groups/sep/, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.173, Biological Research Related to Deafness and Communicative Disorders, National Institutes of Health, HHS) Dated: February 9, 2012. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2012–3544 Filed 2–14–12; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as 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. Name of Committee: National Institute on Deafness and Other Communication PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings 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. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Systems Neuroscience. Date: February 29–March 1, 2012. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). E:\FR\FM\15FEN1.SGM 15FEN1

Agencies

[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Notices]
[Pages 8887-8888]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3569]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Deafness and Other Communication Disorders 
Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as

[[Page 8888]]

amended (5 U.S.C. App.), notice is hereby given of the following 
meetings.
    The meetings 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.

    Name of Committee: National Institute on Deafness and Other 
Communication Disorders Special Emphasis Panel; Outcome of Cochlear 
Implants.
    Date: March 1, 2012.
    Time: 9 a.m. to 10:30 a.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6120 Executive Blvd., 
Rockville, MD 20852 (Telephone Conference Call).
    Contact Person: Shiguang Yang, DVM, Ph.D., Scientific Review 
Officer, Division of Extramural Activities, NIDCD, NIH, 6120 
Executive Blvd., Bethesda, MD 20892, 301-496-8683.

    Name of Committee: National Institute on Deafness and Other 
Communication Disorders Special Emphasis Panel; H & B Small Grants.
    Date: March 7, 2012.
    Time: 12 p.m. to 3 p.m..
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6120 Executive Blvd. 
Rockville, MD 20852 (Telephone Conference Call).
    Contact Person: Sheo Singh, Ph.D. Scientific Review Officer, 
Scientific Review Branch, Division of Extramural Activities, 
Executive Plaza South, Room 400C, 6120 Executive Blvd., Bethesda, MD 
20892, 301-496-8683, singhs@nidcd.nih.gov.

    Name of Committee: National Institute on Deafness and Other 
Communication Disorders; Special Emphasis Panel; R03-VSL.
    Date: March 8, 2012.
    Time: 11 a.m. to 1 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6120 Executive Blvd., 
Rockville, MD 20852, (Telephone Conference Call).
    Contact Person: Christine A. Livingston, Ph.D., Scientific 
Review Officer Division of Extramural Activities, National 
Institutes of Health/NIDCD, 6120 Executive Blvd.--MSC 7180, 
Bethesda, MD 20892 (301) 496-8683, livingsc@mail.nih.gov.

    Name of Committee: National Institute on Deafness and Other 
Communication Disorders Special Emphasis Panel; R03 Chemosensory.
    Date: March 9, 2012.
    Time: 11 a.m. to 1 p.m..
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6120 Executive Blvd., 
Rockville, MD 20852, (Telephone Conference Call).
    Contact Person: Kausik Ray, Ph.D., Scientific Review Officer, 
National Institute on Deafness and Other Communication Disorders, 
National Institutes of Health, Rockville, MD 20850, 301-402-3587, 
rayk@nidcd.nih.gov.

    Name of Committee: National Institute on Deafness and Other 
Communication Disorders Special Emphasis Panel; Clinical Trial 
Review.
    Date: March 13, 2012.
    Time: 11 a.m. to 1 p.m..
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6120 Executive Blvd., 
Rockville, MD 20852, (Telephone Conference Call).
    Contact Person: Christine A. Livingston, Ph.D., Scientific 
Review Officer, Division of Extramural Activities, National 
Institutes of Health/NIDCD, 6120 Executive Blvd.--MSC 7180, 
Bethesda, MD 20892, (301) 496-8683, livingsc@mail.nih.gov.

    Information is also available on the Institute's/Center's home 
page: https://www.nidcd.nih.gov/about/groups/sep/, where an agenda 
and any additional information for the meeting will be posted when 
available.

(Catalogue of Federal Domestic Assistance Program Nos. 93.173, 
Biological Research Related to Deafness and Communicative Disorders, 
National Institutes of Health, HHS)

    Dated: February 9, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2012-3569 Filed 2-14-12; 8:45 am]
BILLING CODE 4140-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.