80 FR 11994 - Center for Scientific Review; Notice of Closed Meetings
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 43 (March 5, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 43 (March 5, 2015)
| Page Range | 11994-11995 | |
| FR Document | 2015-05008 |
[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)] [Notices] [Pages 11994-11995] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05008] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 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; PAR-14-317 and 318: Role of the Microbiome in HIV Vaccine Responses. Date: March 18, 2015. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Mary Clare Walker, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5208, MSC 7852, Bethesda, MD 20892, (301) 435-1165, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; Special R01 Review. Date: March 25, 2015. Time: 3:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Wallace Ip, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5128, MSC 7840, Bethesda, MD 20892, 301-435- 1191, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA ES-14-010: Centers of Excellence on Environmental Health Disparities Research. Date: March 30-April 1, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Ritz Carlton Hotel, 1150 22nd Street NW., Washington, DC 20037. Contact Person: Wenchi Liang, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3150, MSC 7770, Bethesda, MD 20892, 301-435- 0681, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; Program Project: ``Cloud based Data Sharing and Analysis with Privacy Protection''. Date: March 30, 2015. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Raymond Jacobson, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5858, MSC 7849, Bethesda, MD 20892, 301-996-7702, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; TW-14-003: Limited Competition: Research Training for Career Development of Junior Faculty in Medical Education Partnership Initiative (MEPI) Institutions. Date: March 31, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Renaissance Mayflower Hotel, 1127 Connecticut Avenue NW., Washington, DC 20036. Contact Person: Hilary D. Sigmon, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5216, MSC 7852, Bethesda, MD 20892, (301) 594-6377, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; AIDS and AIDS Related Applications. Date: March 31, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications and/or proposals. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Jingsheng Tuo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5207, Bethesda, MD 20892, 301-451-8754, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR-14-280: Pilot Centers for Precision Disease Modeling. [[Page 11995]] Date: March 31, 2015. Time: 8:00 a.m. to 9:00 p.m. Agenda: To review and evaluate cooperative agreement applications. Place: Residence Inn Washington DC, 1199 Vermont Avenue NW., Washington, DC 20005. Contact Person: Kenneth Ryan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3218, MSC 7717, Bethesda, MD 20892, 301-435- 0229, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Pregnancy/Neonatology Research. Date: March 31, 2015. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Gary Hunnicutt, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6164, MSC 7892, Bethesda, MD 20892, 301-435-0229, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Innovative Molecular Analysis Technology. Date: March 31, 2015. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Zhang-Zhi Hu, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6186, MSC 7804, Bethesda, MD 20892, (301) 594- 2414, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cancer Therapeutics. Date: March 31, 2015. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Careen K. Tang-Toth, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6214, MSC 7804, Bethesda, MD 20892, (301) 435-3504, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Organelles' Dysfunction in Neurodegerative Disorders. Date: March 31, 2015. Time: 4:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Alessandra C. Rovescalli, Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Rm 5205, MSC 7846, Bethesda, MD 20892, (301) 435-1021, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; ``Program Project: BTRC Center Review''. Date: March 31-April 2, 2015. Time: 6:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Contact Person: Craig Giroux, Ph.D., Scientific Review Officer, BST IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5150, Bethesda, MD 20892, 301- 435-2204, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA-RM-14-015: Facile Methods and Technologies for Synthesis of Biomedically Relevant Carbohydrates. Date: March 31, 2015. Time: 12:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Kathryn M. Koeller, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4166, MSC 7806, Bethesda, MD 20892, 301-435-2681, [email protected]. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: February 27, 2015. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2015-05008 Filed 3-4-15; 8:45 am] BILLING CODE 4140-01-P
![11994 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices
Any application by Dr. Rockmore for Estimation—Health Risks from Scientific Review, National Institutes of
termination of debarment under section Environmental Exposures; 93.142, NIEHS Health, 6701 Rockledge Drive, Room 5128,
306(d) of the FD&C Act should be Hazardous Waste Worker Health and Safety MSC 7840, Bethesda, MD 20892, 301–435–
Training; 93.143, NIEHS Superfund 1191, ipws@mail.nih.gov.
identified with Docket No. FDA–2010–
Hazardous Substances—Basic Research and Name of Committee: Center for Scientific
N–0302 and sent to the Division of Education; 93.894, Resources and Manpower Review Special Emphasis Panel; RFA ES–14–
Dockets Management (see ADDRESSES). Development in the Environmental Health 010: Centers of Excellence on Environmental
All such submissions are to be filed in Sciences; 93.113, Biological Response to Health Disparities Research.
four copies. The public availability of Environmental Health Hazards; 93.114, Date: March 30–April 1, 2015.
information in these submissions is Applied Toxicological Research and Testing, Time: 8:00 a.m. to 5:00 p.m.
governed by 21 CFR 10.20(j). Publicly National Institutes of Health, HHS) Agenda: To review and evaluate grant
available submissions may be seen in applications.
Dated: February 25, 2015.
the Division of Dockets Management Place: Ritz Carlton Hotel, 1150 22nd Street
Carolyn Baum, NW., Washington, DC 20037.
between 9 a.m. and 4 p.m., Monday Program Analyst, Office of Federal Advisory Contact Person: Wenchi Liang, Ph.D.,
through Friday. Persons with access to Committee Policy. Scientific Review Officer, Center for
the Internet may obtain documents in [FR Doc. 2015–05004 Filed 3–4–15; 8:45 am] Scientific Review, National Institutes of
the Docket at http:// Health, 6701 Rockledge Drive, Room 3150,
BILLING CODE 4140–01P
www.regulations.gov. MSC 7770, Bethesda, MD 20892, 301–435–
0681, liangw3@csr.nih.gov.
Dated: February 24, 2015.
Name of Committee: Center for Scientific
Stephen Ostroff, DEPARTMENT OF HEALTH AND Review Special Emphasis Panel; Program
Director, Office of the Chief Scientist. HUMAN SERVICES Project: ‘‘Cloud based Data Sharing and
[FR Doc. 2015–05045 Filed 3–4–15; 8:45 am] Analysis with Privacy Protection’’.
National Institutes of Health Date: March 30, 2015.
BILLING CODE 4164–01–P
Time: 1:00 p.m. to 4:00 p.m.
Center for Scientific Review; Notice of Agenda: To review and evaluate grant
Closed Meetings applications.
DEPARTMENT OF HEALTH AND Place: National Institutes of Health, 6701
HUMAN SERVICES Pursuant to section 10(d) of the Rockledge Drive, Bethesda, MD 20892,
Federal Advisory Committee Act, as (Virtual Meeting).
National Institutes of Health amended (5 U.S.C. App.), notice is Contact Person: Raymond Jacobson, Ph.D.,
hereby given of the following meetings. Scientific Review Officer, Center for
National Institute of Environmental The meetings will be closed to the Scientific Review, National Institutes of
Health Sciences; Notice of Closed public in accordance with the Health, 6701 Rockledge Drive, Room 5858,
Meeting provisions set forth in sections MSC 7849, Bethesda, MD 20892, 301–996–
7702, jacobsonrh@csr.nih.gov.
Pursuant to section 10(d) of the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and Name of Committee: Center for Scientific
Federal Advisory Committee Act, as Review Special Emphasis Panel; TW–14–003:
amended (5 U.S.C. App.), notice is the discussions could disclose Limited Competition: Research Training for
hereby given of the following meeting. confidential trade secrets or commercial Career Development of Junior Faculty in
The meeting will be closed to the property such as patentable material, Medical Education Partnership Initiative
public in accordance with the and personal information concerning (MEPI) Institutions.
provisions set forth in sections individuals associated with the grant Date: March 31, 2015.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., applications, the disclosure of which Time: 8:00 a.m. to 6:00 p.m.
would constitute a clearly unwarranted Agenda: To review and evaluate grant
as amended. The grant applications and applications.
the discussions could disclose invasion of personal privacy.
Place: Renaissance Mayflower Hotel, 1127
confidential trade secrets or commercial Name of Committee: Center for Scientific Connecticut Avenue NW., Washington, DC
property such as patentable material, Review Special Emphasis Panel; PAR–14– 20036.
and personal information concerning 317 and 318: Role of the Microbiome in HIV Contact Person: Hilary D. Sigmon, Ph.D.,
individuals associated with the grant Vaccine Responses. Scientific Review Officer, Center for
applications, the disclosure of which Date: March 18, 2015. Scientific Review, National Institutes of
would constitute a clearly unwarranted Time: 10:00 a.m. to 5:00 p.m. Health, 6701 Rockledge Drive, Room 5216,
Agenda: To review and evaluate grant MSC 7852, Bethesda, MD 20892, (301) 594–
invasion of personal privacy. applications. 6377, sigmonh@csr.nih.gov.
Name of Committee: National Institute of Place: National Institutes of Health, 6701 Name of Committee: Center for Scientific
Environmental Health Sciences Special Rockledge Drive, Bethesda, MD 20892. Review Special Emphasis Panel; AIDS and
Emphasis Panel, International Collaborations Contact Person: Mary Clare Walker, Ph.D., AIDS Related Applications.
in Environmental Health. Scientific Review Officer, Center for Date: March 31, 2015.
Date: March 24–25, 2015. Scientific Review, National Institutes of Time: 8:00 a.m. to 6:00 p.m.
Time: 8:00 a.m. to 5:00 p.m. Health, 6701 Rockledge Drive, Room 5208, Agenda: To review and evaluate grant
Agenda: To review and evaluate grant MSC 7852, Bethesda, MD 20892, (301) 435– applications and/or proposals.
applications. 1165, walkermc@csr.nih.gov. Place: Hyatt Regency Bethesda, One
Place: NIEHS/National Institutes of Health, Name of Committee: Center for Scientific Bethesda Metro Center, 7400 Wisconsin
Keystone Building, 530 Davis Drive, Research Review Special Emphasis Panel; Special R01 Avenue, Bethesda, MD 20814.
Triangle Park, NC 27709, (Virtual Meeting). Review. Contact Person: Jingsheng Tuo, Ph.D.,
Contact Person: Sally Eckert-Tilotta, Ph.D., Date: March 25, 2015. Scientific Review Officer, Center for
mstockstill on DSK4VPTVN1PROD with NOTICES
Scientific Review Officer, National Institute Time: 3:00 p.m. to 5:00 p.m. Scientific Review, National Institutes of
of Environmental Health Sciences, Office of Agenda: To review and evaluate grant Health, 6701 Rockledge Drive, Room 5207,
Program Operations, Scientific Review applications. Bethesda, MD 20892, 301–451–8754, tuoj@
Branch, P.O. Box 12233, Research Triangle Place: National Institutes of Health, 6701 nei.nih.gov.
Park, NC 27709, (919) 541–1446, eckertt1@ Rockledge Drive, Bethesda, MD 20892, Name of Committee: Center for Scientific
niehs.nih.gov. (Telephone Conference Call). Review Special Emphasis Panel; PAR–14–
(Catalogue of Federal Domestic Assistance Contact Person: Wallace Ip, Ph.D., 280: Pilot Centers for Precision Disease
Program Nos. 93.115, Biometry and Risk Scientific Review Officer, Center for Modeling.
VerDate Sep<11>2014 19:28 Mar 04, 2015 Jkt 235001 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 E:\FR\FM\05MRN1.SGM 05MRN1](https://thefederalregister.org/doc/80_FR_12037/page/1.svg)
![Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 11995
Date: March 31, 2015. of Health, Center for Scientific Review, 6701 approved or pending drug product
Time: 8:00 a.m. to 9:00 p.m. Rockledge Drive, Rm 5205, MSC 7846, application. FDA bases this order on a
Agenda: To review and evaluate Bethesda, MD 20892, (301) 435–1021, finding that Dr. Hargrave was convicted
cooperative agreement applications. rovescaa@mail.nih.gov. of a misdemeanor under Federal law for
Place: Residence Inn Washington DC, 1199 Name of Committee: Center for Scientific
Vermont Avenue NW., Washington, DC conduct relating to the regulation of a
Review Special Emphasis Panel; ‘‘Program drug product under the FD&C Act and
20005. Project: BTRC Center Review’’.
Contact Person: Kenneth Ryan, Ph.D., that the type of conduct underlying the
Date: March 31–April 2, 2015.
Scientific Review Officer, Center for Time: 6:00 p.m. to 5:00 p.m. conviction undermines the process for
Scientific Review, National Institutes of Agenda: To review and evaluate grant the regulation of drugs. In determining
Health, 6701 Rockledge Drive, Room 3218, applications. the appropriateness and period of Dr.
MSC 7717, Bethesda, MD 20892, 301–435– Place: Bethesda Marriott Suites, 6711 Hargrave’s debarment, FDA has
0229, kenneth.ryan@nih.hhs.gov. Democracy Boulevard, Bethesda, MD 20817. considered the relevant factors listed in
Name of Committee: Center for Scientific Contact Person: Craig Giroux, Ph.D., the FD&C Act. Dr. Hargrave has failed to
Review Special Emphasis Panel; Member Scientific Review Officer, BST IRG, Center file with the Agency information and
Conflict: Pregnancy/Neonatology Research. for Scientific Review, National Institutes of analyses sufficient to create a basis for
Date: March 31, 2015. Health, 6701 Rockledge Drive, Room 5150,
Time: 9:00 a.m. to 5:00 p.m.
a hearing concerning this action.
Bethesda, MD 20892, 301–435–2204,
Agenda: To review and evaluate grant girouxcn@csr.nih.gov. DATES: The order is effective March 5,
applications. Name of Committee: Center for Scientific
2015.
Place: National Institutes of Health, 6701 Review Special Emphasis Panel; RFA–RM– ADDRESSES: Submit applications for
Rockledge Drive, Bethesda, MD 20892, 14–015: Facile Methods and Technologies for termination of debarment to the
(Virtual Meeting). Synthesis of Biomedically Relevant
Contact Person: Gary Hunnicutt, Ph.D.,
Division of Dockets Management (HFA–
Carbohydrates. 305), Food and Drug Administration,
Scientific Review Officer, Center for Date: March 31, 2015.
Scientific Review, National Institutes of 5630 Fishers Lane, Rm. 1061, Rockville,
Time: 12:00 p.m. to 6:00 p.m.
Health, 6701 Rockledge Drive, Room 6164, MD 20852.
Agenda: To review and evaluate grant
MSC 7892, Bethesda, MD 20892, 301–435– applications. FOR FURTHER INFORMATION CONTACT:
0229, gary.hunnicutt@nih.gov. Place: National Institutes of Health, 6701 Nathan Doty, Office of Scientific
Name of Committee: Center for Scientific Rockledge Drive, Bethesda, MD 20892. Integrity, Food and Drug
Review Special Emphasis Panel; Small Contact Person: Kathryn M. Koeller, Ph.D., Administration, 10903 New Hampshire
Business: Innovative Molecular Analysis Scientific Review Officer, Center for Ave., Silver Spring, MD 20993, 301–
Technology. Scientific Review, National Institutes of 796–8556.
Date: March 31, 2015. Health, 6701 Rockledge Drive, Room 4166,
Time: 1:00 p.m. to 5:00 p.m. SUPPLEMENTARY INFORMATION:
MSC 7806, Bethesda, MD 20892, 301–435–
Agenda: To review and evaluate grant 2681, koellerk@csr.nih.gov. I. Background
applications. (Catalogue of Federal Domestic Assistance
Place: National Institutes of Health, 6701 On August 11, 2009, in the U.S.
Program Nos. 93.306, Comparative Medicine;
Rockledge Drive, Bethesda, MD 20892, 93.333, Clinical Research, 93.306, 93.333,
District Court for the Northern District
(Telephone Conference Call). 93.337, 93.393–93.396, 93.837–93.844, of New York, Dr. Hargrave, a physician,
Contact Person: Zhang-Zhi Hu, MD, 93.846–93.878, 93.892, 93.893, National pled guilty to a misdemeanor under the
Scientific Review Officer, Center for Institutes of Health, HHS) FD&C Act, namely misbranding a drug
Scientific Review, National Institutes of in violation of sections 301(k), 502(i)(3)
Health, 6701 Rockledge Drive, Room 6186, Dated: February 27, 2015.
and 303(a)(1) of the FD&C Act (21 U.S.C.
MSC 7804, Bethesda, MD 20892, (301) 594– Anna Snouffer,
2414, huzhuang@csr.nih.gov.
331(k), 352(i)(3), 333(a)(1)) and 18
Deputy Director, Office of Federal Advisory U.S.C. 2. The basis for this conviction
Name of Committee: Center for Scientific Committee Policy.
Review Special Emphasis Panel; Member
was conduct surrounding his injection
[FR Doc. 2015–05008 Filed 3–4–15; 8:45 am]
Conflict: Cancer Therapeutics. of patients seeking treatment with
BILLING CODE 4140–01–P BOTOX/BOTOX Cosmetic (BOTOX)
Date: March 31, 2015.
Time: 1:00 p.m. to 4:00 p.m. with a product, TRI-toxin, distributed
Agenda: To review and evaluate grant by Toxin Research International, Inc.
applications. DEPARTMENT OF HEALTH AND BOTOX is a biological product derived
Place: National Institutes of Health, 6701 HUMAN SERVICES from Botulinum Toxin Type A that is
Rockledge Drive, Bethesda, MD 20892, manufactured by Allergan, Inc., and was
(Telephone Conference Call). Food and Drug Administration
approved by FDA for use on humans for
Contact Person: Careen K. Tang-Toth, [Docket No. FDA–2010–N–0299]
Ph.D., Scientific Review Officer, Center for
the treatment of facial wrinkles in 1991.
Scientific Review, National Institutes of According to the records of the criminal
Douglas M. Hargrave; Denial of proceedings, Dr. Hargrave’s colleague in
Health, 6701 Rockledge Drive, Room 6214, Hearing; Final Debarment Order
MSC 7804, Bethesda, MD 20892, (301) 435– the same medical practice, The Plastic
3504, tothct@csr.nih.gov. AGENCY: Food and Drug Administration, Surgery Group (TPSG), directed a nurse
Name of Committee: Center for Scientific HHS. to obtain 31 vials of TRI-toxin, an
Review Special Emphasis Panel; Member ACTION: Notice. unapproved drug product, which was
Conflict: Organelles’ Dysfunction in represented by its distributor as
Neurodegerative Disorders. SUMMARY: The Food and Drug ‘‘Botulinum Toxin Type A.’’ Dr.
Date: March 31, 2015.
mstockstill on DSK4VPTVN1PROD with NOTICES
Administration (FDA) is denying a Hargrave then proceeded to inject
Time: 4:00 p.m. to 6:00 p.m. request for a hearing submitted by Dr. approximately 25 patients, who
Agenda: To review and evaluate grant
Douglas M. Hargrave (Dr. Hargrave), and believed they were being injected with
applications.
Place: National Institutes of Health, 6701 is issuing an order under the Federal BOTOX, with TRI-toxin as a substitute.
Rockledge Drive, Bethesda, MD 20892, Food, Drug, and Cosmetic Act (the Dr. Hargrave is subject to debarment
(Telephone Conference Call). FD&C Act) debarring Dr. Hargrave for 2 based on a finding, under section
Contact Person: Alessandra C. Rovescalli, years from providing services in any 306(b)(2)(B)(i)(I) of the FD&C Act (21
Scientific Review Officer, National Institutes capacity to a person that has an U.S.C. 335a(b)(2)(B)(i)(I)): (1) That he
VerDate Sep<11>2014 19:28 Mar 04, 2015 Jkt 235001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\FR\FM\05MRN1.SGM 05MRN1](https://thefederalregister.org/doc/80_FR_12037/page/2.svg)
Document Created: 2015-12-18 12:08:54
Document Modified: 2015-12-18 12:08:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | March 18, 2015. | |
| FR Citation | 80 FR 11994 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR