National Institute of Mental Health; Notice of Closed Meetings, 54348 [2010-22185]

Download as PDF 54348 Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 on the draft guidance by November 8, 2010. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1–800–835– 4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov.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. FOR FURTHER INFORMATION CONTACT: Benjamin A. Chacko, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Bar Code Label Requirements—Questions and Answers (Question 12 Update)’’ dated August 2010. FDA regulations require that certain human drug and biological product labels contain a bar code (§ 201.25 (21 CFR 201.25)). This draft guidance provides you, manufacturers of a licensed vaccine, with advice concerning compliance with the bar code label requirements. Previously, FDA issued questions and answers regarding how the bar code label requirements apply to specific products or circumstances in the Bar Code Guidance (October 5, 2006, 71 FR 58739). In this guidance, FDA is proposing to amend our response to question 12 (Q12) in the Bar Code Guidance to provide recommendations to manufacturers of licensed vaccines in connection with the use of alternative coding technologies. We are revising our response because we believe that an alternative regulatory program, comprised of alternative technology such as two dimensional symbology, could render the use of linear bar codes unnecessary for patient safety and could enhance health care providers’ ability to comply with the National Childhood VerDate Mar<15>2010 15:24 Sep 03, 2010 Jkt 220001 Vaccine Injury Act of 1986 (Public Law 99–660) (42 U.S.C. 300aa-25(a))). We would consider granting a request for exemption to the bar code requirement under § 201.25(d)(ii) in connection with such use. II. Paperwork Reduction Act of 1995 The draft guidance refers to previously approved collections of information found in FDA regulations. The collection of information in 21 CFR part 201 has been approved under OMB control number 0910–0537. III. Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Dated: August 16, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–22169 Filed 9–3–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; 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, PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 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 of Mental Health Special Emphasis Panel; ITVC Conflicts. Date: October 6, 2010. Time: 11 a.m. to 12:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852. (Telephone Conference Call) Contact Person: Enid Light, PhD, Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Boulevard, Room 6132, MSC 9608, Bethesda, MD 20852, 301–443–3599, elight@mail.nih.gov. Name of Committee: National Institute of Mental Health Special Emphasis Panel; K99. Date: October 18, 2010. Time: 11 a.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852. (Telephone Conference Call) Contact Person: Megan Libbey, PhD, Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6148, MSC 9609, Rockville, MD 20852–9609, 301–402–6807, libbeym@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.242, Mental Health Research Grants; 93.281, Scientist Development Award, Scientist Development Award for Clinicians, and Research Scientist Award; 93.282, Mental Health National Research Service Awards for Research Training, National Institutes of Health, HHS) Dated: August 31, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–22185 Filed 9–3–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; 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 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 E:\FR\FM\07SEN1.SGM 07SEN1

Agencies

[Federal Register Volume 75, Number 172 (Tuesday, September 7, 2010)]
[Notices]
[Page 54348]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22185]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Mental Health; 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: National Institute of Mental Health Special 
Emphasis Panel; ITVC Conflicts.
    Date: October 6, 2010.
    Time: 11 a.m. to 12:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Neuroscience Center, 6001 
Executive Boulevard, Rockville, MD 20852. (Telephone Conference 
Call)
    Contact Person: Enid Light, PhD, Scientific Review Officer, 
Division of Extramural Activities, National Institute of Mental 
Health, NIH, Neuroscience Center, 6001 Executive Boulevard, Room 
6132, MSC 9608, Bethesda, MD 20852, 301-443-3599, 
elight@mail.nih.gov.

    Name of Committee: National Institute of Mental Health Special 
Emphasis Panel; K99.
    Date: October 18, 2010.
    Time: 11 a.m. to 2 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Neuroscience Center, 6001 
Executive Boulevard, Rockville, MD 20852. (Telephone Conference 
Call)
    Contact Person: Megan Libbey, PhD, Scientific Review Officer, 
Division of Extramural Activities, National Institute of Mental 
Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6148, 
MSC 9609, Rockville, MD 20852-9609, 301-402-6807, 
libbeym@mail.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.242, 
Mental Health Research Grants; 93.281, Scientist Development Award, 
Scientist Development Award for Clinicians, and Research Scientist 
Award; 93.282, Mental Health National Research Service Awards for 
Research Training, National Institutes of Health, HHS)

    Dated: August 31, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-22185 Filed 9-3-10; 8:45 am]
BILLING CODE 4140-01-P
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