Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting, 37232 [2013-14649]

Download as PDF 37232 Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Notices That letter stated that OGD would accept ANDAs with the ICH recommended long-term room temperature conditions for stability studies, 25 ± 2° C, 60 ± 5 percent RH. On September 25, 2012 (77 FR 58999), FDA announced the availability of draft guidance for industry on ‘‘ANDAs: Stability Testing of Drug Substances and Products.’’ The public comment period closed on December 24, 2012. We are finalizing the guidance with minor changes and intend to publish a draft guidance to address the public comments in a question-and-answer format in the near future. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on this stability testing for generic drug substances and products. 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. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of 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 and will be posted to the docket at https:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.regulations.gov or https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm. TKELLEY on DSK3SPTVN1PROD with NOTICES Dated: June 14, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–14674 Filed 6–19–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of 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 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 notify the contact person listed below in advance of the meeting. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; Cardio-metabolic risk and epigenetic differences among children conceives by infertility. Date: July 1, 2013. Time: 1:00 p.m. to 5:00 p.m. Agenda: To provide concept review. Place: National Institutes of Health, 6100 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Sathasiva B. Kandasamy, Ph.D., Scientific Review Officer, Division of Scientific Review, National Institute of Child Health and Human Development, 6100 Executive Boulevard, Rockville, MD 20892– 9304, (301) 435–6680, skandasa@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. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 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: June 14, 2013. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–14649 Filed 6–19–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; 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 VerDate Mar<15>2010 17:01 Jun 19, 2013 Jkt 229001 PO 00000 Frm 00034 Fmt 4703 Sfmt 9990 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 Aging Special Emphasis Panel; NIA DBSR DATASETS. Date: July 11–12, 2013. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Alfonso Latoni, Ph.D., Scientific Review Branch, National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301–402–7702, Alfonso.Latoni@nih.gov. Name of Committee: National Institute on Aging Special Emphasis Panel; Osteoimmunology. Date: July 11, 2013. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20814, (Telephone Conference Call). Contact Person: Elaine Lewis, Ph.D., Scientific Review Branch, National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301–402–7707, elainelewis@nia.nih.gov. Name of Committee: National Institute on Aging Special Emphasis Panel; Treatment of Obesity in Older Adults. Date: July 18, 2013. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20814, (Telephone Conference Call). Contact Person: Elaine Lewis, Ph.D., Scientific Review Branch, National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301–402–7707, elainelewis@nia.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: June 14, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–14647 Filed 6–19–13; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\20JNN1.SGM 20JNN1

Agencies

[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Notices]
[Page 37232]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14649]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Eunice Kennedy Shriver National Institute of Child Health & Human 
Development; Notice of 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 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 notify the contact person listed below in 
advance of the meeting.

    Name of Committee: National Institute of Child Health and Human 
Development Special Emphasis Panel; Cardio-metabolic risk and 
epigenetic differences among children conceives by infertility.
    Date: July 1, 2013.
    Time: 1:00 p.m. to 5:00 p.m.
    Agenda: To provide concept review.
    Place: National Institutes of Health, 6100 Executive Boulevard, 
Rockville, MD 20852 (Telephone Conference Call).
    Contact Person: Sathasiva B. Kandasamy, Ph.D., Scientific Review 
Officer, Division of Scientific Review, National Institute of Child 
Health and Human Development, 6100 Executive Boulevard, Rockville, 
MD 20892-9304, (301) 435-6680, skandasa@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.

(Catalogue of Federal Domestic Assistance Program Nos. 93.864, 
Population Research; 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: June 14, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2013-14649 Filed 6-19-13; 8:45 am]
BILLING CODE 4140-01-P

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