Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting, 28050-28051 [E9-13759]

Download as PDF 28050 Federal Register / Vol. 74, No. 112 / Friday, June 12, 2009 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–N–0377] (formerly Docket No. 2007N–0299) Allyn M. Norman; Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) debarring Dr. Allyn M. Norman for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Norman was convicted of a misdemeanor under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product or otherwise relating to the regulation of drug products under the act, and that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Norman failed to request a hearing and, therefore, has waived his opportunity for a hearing concerning this action. DATES: This order is effective June 12, 2009. Submit applications for termination of debarment to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Robert L. Hummel, Sr., Division of Compliance Policy (HFC–230), Office of Enforcement, Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240–632–6845. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background On October 28, 2002, the U.S. District Court for the Western District of New York accepted Dr. Norman’s plea of guilty to one count of failure to maintain adequate and accurate records relating to the use of investigational new drugs, a Federal misdemeanor offense under 21 U.S.C. 331(e) and 333(a)(1). On February 5, 2003, the U.S. District Court for the Western District of New York entered a judgment of conviction against Dr. Norman for this offense. The basis of this conviction was Dr. Norman’s creation and submission of falsified study data in required reports VerDate Nov<24>2008 17:53 Jun 11, 2009 Jkt 217001 to the sponsor of an investigational new drug application (IND) study, in violation of section 505(i) of the act (21 U.S.C. 355(i)) and 21 CFR 312.62(a) and (b). Dr. Norman failed to conduct the study according to the approved protocol, reported the enrollment of nonexistent subjects in the study, and fabricated all of the pertinent study records associated with these subjects. Dr. Norman’s failure to comply with the requirements of the act and FDA regulations concerning the conduct of an IND study is the type of conduct that undermines confidence in the results of clinical studies that are relied on in the approval process for drug products. As a result of Dr. Norman’s conviction, FDA sent to Dr. Norman, by certified letter on October 10, 2007, a proposal to debar Dr. Norman for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. The letter also offered Dr. Norman notice of an opportunity for a hearing on the proposal in accordance with section 306 of the act (21 U.S.C. 335a) and 21 CFR part 12. FDA based the debarment proposal on the findings, under section 306(b)(2)(B)(i)(I) of the act, that Dr. Norman was convicted of a misdemeanor under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product or otherwise relating to the regulation of drug products under the act, and that the type of conduct which served as the basis for the conviction undermines the process for the regulation of drugs. The letter notified Dr. Norman that he had 30 days from the date of receipt of the letter to request a hearing. Dr. Norman did not request a hearing. His failure to request a hearing constitutes a waiver of his opportunity for a hearing and a waiver of any contentions concerning his debarment. II. Findings and Order Therefore, the Acting Director, Office of Enforcement, Office of Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the act and under authority delegated to the Acting Director (Staff Manual Guide 1410.35), finds that Dr. Allyn M. Norman has been convicted of a misdemeanor under Federal law for failure to maintain adequate and accurate records relating to the use of investigational new drugs, that Dr. Norman’s conduct relates to the development or approval, including the process for development or approval, of a drug product or otherwise relates to the regulation of drug products under the act, and that Dr. Norman’s conduct, PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 which served as the basis for his conviction, is the type of conduct that undermines the process for the regulation of drugs. As a result of the foregoing findings, Dr. Norman is debarred for 5 years from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES) (see sections 306(c)(1)(B) and (c)(2)(A)(iii) and 201(dd) of the act (21 U.S.C. 321(dd)). Any person with an approved or pending drug product application who knowingly uses the services of Dr. Norman, in any capacity, during his period of debarment, will be subject to civil money penalties (section 307(a)(6) of the act (21 U.S.C. 355b(a)(6))). If Dr. Norman, during his period of debarment, provides services in any capacity to a person with an approved or pending drug product application, he will be subject to civil money penalties (section 307(a)(7) of the act). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Dr. Norman during his period of debarment. Any application by Dr. Norman for termination of debarment under section 306(d)(4) of the act should be identified with Docket No. FDA–2007–N–0377 (formerly Docket No. 2007N–0299) and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: June 4, 2009. Alyson L. Saben, Acting Director, Office of Enforcement, Office of Regulatory Affairs. [FR Doc. E9–13766 Filed 6–11–09; 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 & Human Development; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. E:\FR\FM\12JNN1.SGM 12JNN1 Federal Register / Vol. 74, No. 112 / Friday, June 12, 2009 / Notices 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; Progression of Gestational Diabetes to Type 2 Diabetes. Date: July 6, 2009. Time: 1:30 p.m. to 3:30 p.m. Agenda: To provide concept review of proposed concept review. Place: National Institutes of Health, 6100 Executive Boulevard, Room 5B01, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Sathasiva B. Kandasamy, PhD, Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health, and Human Development, 6100 Executive Boulevard, Room 5B01, Bethesda, MD 20892–9304, (301) 435–6680, skandasa@mail.nih.gov. (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) Associates Research Development Award (EARDA). Date: July 9, 2009. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015. Contact Person: Carla T. Walls, PhD, Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health, and Human Development, NIH, 6100 Executive Blvd., Room 5B01, Bethesda, MD 20892, (301) 435–6898, wallsc@mail.nih.gov. (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 5, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–13760 Filed 6–11–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: June 4, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–13759 Filed 6–11–09; 8:45 am] National Institutes of Health BILLING CODE 4140–01–P 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & 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 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 Child Health and Human Development Special Emphasis Panel; Extramural VerDate Nov<24>2008 17:53 Jun 11, 2009 Jkt 217001 National Center for Complementary & Alternative Medicine; Notice of Closed Meetings Name of Committee: National Center for Complementary and Alternative Medicine Special Emphasis Panel; ARRA P30 Faculty Development Grants. Date: June 22, 2009. Time: 2:30 p.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Martin H. Goldrosen, PhD, Director, Office of Scientific Review, National Center for Complementary and Alternative Medicine, National Institutes of PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 28051 Health, 6707 Democracy Blvd., Ste., 106, Bethesda, MD 20892–5475, (301) 451–6331, goldrosm@mail.nih.gov. This notice is being published less than 15 days prior to meeting due to scheduling conflicts. Name of Committee: National Center for Complementary and Alternative Medicine Special Emphasis Panel; ARRA SEP 3P01/ 3R01. Date: July 16, 2009. Time: 12 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Martina Schmidt, PhD, Scientific Review Officer, Office of Scientific Review, National Center for Complementary & Alternative Medicine, NIH, 6707 Democracy Blvd., Suite 401, Bethesda, MD 20892, 301–594–3456, schmidma@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.701, ARRA Related Biomedical Research and Research Support Awards.; 93.213, Research and Training in Complementary and Alternative Medicine, National Institutes of Health, HHS) Dated: June 5, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–13761 Filed 6–11–09; 8:45 am] BILLING CODE 4140–01–P 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; ARRA—The Biomarkers of Autism at 12 Months: From Brain Overgrowth to Genes. Date: June 18, 2009. Time: 8 p.m. to 9 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\12JNN1.SGM 12JNN1

Agencies

[Federal Register Volume 74, Number 112 (Friday, June 12, 2009)]
[Notices]
[Pages 28050-28051]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13759]


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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(a) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of the following 
meeting.

[[Page 28051]]

    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; Progression of Gestational 
Diabetes to Type 2 Diabetes.
    Date: July 6, 2009.
    Time: 1:30 p.m. to 3:30 p.m.
    Agenda: To provide concept review of proposed concept review.
    Place: National Institutes of Health, 6100 Executive Boulevard, 
Room 5B01, Rockville, MD 20852 (Telephone Conference Call).
    Contact Person: Sathasiva B. Kandasamy, PhD, Scientific Review 
Administrator, Division of Scientific Review, National Institute of 
Child Health, and Human Development, 6100 Executive Boulevard, Room 
5B01, Bethesda, MD 20892-9304, (301) 435-6680, 
skandasa@mail.nih.gov.

(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 4, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-13759 Filed 6-11-09; 8:45 am]
BILLING CODE 4140-01-P

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