Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting, 42099-42100 [2010-17703]

Download as PDF wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area. In the Federal Register of December 24, 1997 (62 FR 67377), FDA published the ICH guidance for industry entitled ‘‘Q3C Impurities: Residual Solvents.’’ The guidance makes recommendations as to what amounts of residual solvents are considered safe in pharmaceuticals. The guidance recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents. Upon issuance in 1997, the text and appendix 1 of the guidance contained several tables and a list of solvents categorizing residual solvents by toxicity, classes 1 through 3, with class 1 being the most toxic. The ICH Quality Expert Working Group (EWG) agreed that the PDE could be modified if reliable and more relevant toxicity data were brought to the attention of the group and the modified PDE could result in a revision of the tables and list. In 1999, ICH instituted a Q3C maintenance agreement and formed a maintenance EWG (Q3C EWG). The agreement provided for the revisitation of solvent PDEs and allowed for minor changes to the tables and list that include the existing PDEs. The agreement also provided that new solvents and PDEs could be added to the tables and list based on adequate toxicity data. In the Federal Register of February 12, 2002 (67 FR 6542), FDA briefly described the process for proposing future revisions to the PDE. In the same notice, the agency announced its decision to delink the tables and list from the Q3C guidance and create a stand alone document entitled ‘‘Q3C: Tables and List’’ to VerDate Mar<15>2010 15:23 Jul 19, 2010 Jkt 220001 facilitate making changes recommended by ICH. II. Draft Recommendation to Revise the PDE for Cumene In March 2010, the ICH Steering Committee agreed that a draft recommendation to revise the PDE for the solvent cumene should be made available for public comment. The draft recommendation is the product of the Q3C EWG of the ICH. Comments about this draft will be considered by FDA and the Q3C EWG. The draft recommendation addresses the safety classification of cumene. When the Q3C guidance was published in 1997, cumene was listed as a class 3 solvent (i.e., a solvent with low toxicity). The Q3C EWG has reviewed new toxicity data derived from a carcinogenicity study performed by the National Toxicology Program. The new data suggest a positive systemic carcinogenic effect, and this observation raises the toxicity associated with this solvent. In March 2010, the ICH Steering Committee was briefed on the results of the Q3C EWG’s analysis. The recommendation was to move cumene from class 3 into class 2. The analysis and draft recommendation are available for review on the Internet (see section IV of this document). This draft recommendation is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft recommendation for the solvent cumene, when finalized, will represent the agency’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. III. Comments 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. The draft recommendation and 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 to Documents and the Maintenance Procedures Persons with access to the Internet may obtain the Q3C guidance documents at https:// PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 42099 www.regulations.gov, https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, or https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm. Information on the Q3C maintenance process as well as proposals, data analysis, and draft and final recommendations for revisions to the tables and list are available at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/ucm125820.htm. Dated: July 9, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–17618 Filed 7–19–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development; 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel Assays of Biological Specimens for Division of Epidemiology, Statistical and Prevention Research. Date: August 10, 2010. Time: 2 p.m. to 4 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 6100 Executive Boulevard, Rockville, MD 20852. (Telephone Conference Call) Contact Person: Sathasiva B. Kandasamy, PhD, Scientific Review Officer, Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6100 Executive Blvd., Room 5B01, Bethesda, MD 20892– 9304. 301–435–6680. skandasa@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; E:\FR\FM\20JYN1.SGM 20JYN1 42100 Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: July 14, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–17703 Filed 7–19–10; 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 Meeting wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse. The meeting will be open to the public as indicated below, 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 notify the Contact Person listed below in advance of the 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 Advisory Council on Drug Abuse. Date: September 14–15, 2010. Closed: September 14, 2010, 2 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Conference Rooms C & D, Rockville, MD 20852. Open: September 15, 2010, 8:30 a.m. to 1 p.m. Agenda: This portion of the meeting will be open to the public for announcements and reports of administrative, legislative and program developments in the drug abuse field. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Conference Rooms C & D, Rockville, MD 20852. VerDate Mar<15>2010 15:23 Jul 19, 2010 Jkt 220001 Contact Person: Teresa Levitin, PhD, Director, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 220, MSC 8401, 6101 Executive Boulevard, Bethesda, MD 20892–8401, (301) 443–2755. Any member of the public interested in presenting oral comments to the committee may notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of organizations may submit a letter of intent, a brief description of the organization represented, and a short description of the oral presentation. Only one representative of an organization may be allowed to present oral comments and if accepted by the committee, presentations may be limited to five minutes. Both printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the committee by forwarding their statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: https:// www.drugabuse.gov/NACDA/ NACDAHome.html, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: July 14, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–17683 Filed 7–19–10; 8:45 am] Name of Committee: National Heart, Lung, and Blood Advisory Council. Date: September 1, 2010. Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Building 31, 31 Center Drive, C-Wing, Room 10, Bethesda, MD 20892. (Telephone Conference Call) Contact Person: Stephen C. Mockrin, PhD, Director, Division of Extramural Research Activities, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7100, Bethesda, MD 20892, (301) 435–0260, mockrins@nhlbi.nih.gov. Information is also available on the Institute’s/Center’s home page: https:// www.nhlbi.nih.gov/meetings/index.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: July 14, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–17681 Filed 7–19–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health BILLING CODE 4140–01–P National Center on Minority and Health Disparities; Notice of Closed Meeting DEPARTMENT OF HEALTH AND HUMAN SERVICES 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 materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. National Institutes of Health National Heart, Lung, and Blood Institute; 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 a meeting of the National Heart, Lung, and Blood Advisory Council. 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 00034 Fmt 4703 Sfmt 4703 Name of Committee: National Center on Minority Health and Health Disparities Special Emphasis Panel, NCMHD Social Determinants of Health (R01) Panel. Date: July 26–28, 2010. Time: 5 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814. E:\FR\FM\20JYN1.SGM 20JYN1

Agencies

[Federal Register Volume 75, Number 138 (Tuesday, July 20, 2010)]
[Notices]
[Pages 42099-42100]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17703]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Eunice Kennedy Shriver National Institute of Child Health and 
Human Development; 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 contract proposals and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the contract proposals, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Child Health and Human 
Development Special Emphasis Panel Assays of Biological Specimens 
for Division of Epidemiology, Statistical and Prevention Research.
    Date: August 10, 2010.
    Time: 2 p.m. to 4 p.m.
    Agenda: To review and evaluate contract proposals.
    Place: National Institutes of Health, 6100 Executive Boulevard, 
Rockville, MD 20852. (Telephone Conference Call)
    Contact Person: Sathasiva B. Kandasamy, PhD, Scientific Review 
Officer, Division of Scientific Review, Eunice Kennedy Shriver 
National Institute of Child Health and Human Development, NIH, 6100 
Executive Blvd., Room 5B01, Bethesda, MD 20892-9304. 301-435-6680. 
skandasa@mail.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.864, 
Population Research;

[[Page 42100]]

93.865, Research for Mothers and Children; 93.929, Center for 
Medical Rehabilitation Research; 93.209, Contraception and 
Infertility Loan Repayment Program, National Institutes of Health, 
HHS)

    Dated: July 14, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-17703 Filed 7-19-10; 8:45 am]
BILLING CODE 4140-01-P

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