Advisory Committee Information Hotline, 31076-31078 [E7-10738]
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31076
Federal Register / Vol. 72, No. 107 / Tuesday, June 5, 2007 / Notices
(memantine hydrochloride). NAMENDA
is indicated for the treatment of
moderate to severe dementia of the
Alzheimer’s type. Subsequent to this
approval, the Patent and Trademark
Office received two patent term
restoration applications for NAMENDA
(U.S. Patent Nos. 5,061,703 and
5,614,560) from Forest Laboratories,
Inc., acting as agent for Merz Pharma
GmbH & Co. KGaA, and the Patent and
Trademark Office requested FDA’s
assistance in determining these patents’
eligibilities for patent term restoration.
In a letter dated January 26, 2007, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of NAMENDA
represented the first permitted
commercial marketing or use of the
product. Shortly thereafter, the Patent
and Trademark Office requested that
FDA determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
NAMENDA is 5,001 days. Of this time,
4,699 days occurred during the testing
phase of the regulatory review period,
while 302 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355(i)) became effective: February 7,
1990. The applicant claims October 9,
1997, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
original IND effective date was February
7, 1990, which was the date the original
IND was removed from clinical hold.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: December 19, 2002.
FDA has verified the applicant’s claim
that the new drug application (NDA)
(NDA 21–487) was initially submitted
on December 19, 2002.
3. The date the application was
approved: October 16, 2003. FDA has
verified the applicant’s claim that NDA
21–487 was approved on October 16,
2003.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,250 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by August 6, 2007.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
December 3, 2007. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document.
Comments and petitions may be seen
in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: May 2, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E7–10730 Filed 6–4–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Advisory Committee Information
Hotline
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that we have revised the Advisory
Committee Information Hotline (the
hotline). The hotline provides the
public with access to the most current
information available on FDA advisory
committee meetings. This notice
supersedes all previously published
announcements of the hotline.
FOR FURTHER INFORMATION CONTACT:
Theresa L. Green, Committee
Management Officer (HF–4), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1220.
The
hotline can be accessed by dialing 1–
800–741–8138 or 301–443–0572. The
advisory committee meeting
information and information updates
can also be accessed via FDA’s advisory
committee calendar at https://
www.fda.gov/oc/advisory/accalendar/
2007/default.htm.
Each advisory committee is assigned
a 10–digit number. This 10–digit
number will appear in each individual
notice of meeting. The public can obtain
information about a particular advisory
committee meeting by using the
committee’s 10–digit number.
Information on the hotline is
preliminary and may change before a
meeting is actually held. The hotline
will be updated when such changes are
made. The following is a list of each
advisory committee’s 10–digit number
to be used when accessing the hotline.
SUPPLEMENTARY INFORMATION:
Advisory Committee
10–Digit Access Number
Office of the Commissioner
8732310001
Risk Communication Advisory Committee
8732112560
Science Board to the FDA
jlentini on PROD1PC65 with NOTICES
Pediatric Advisory Committee
3014512603
Center for Biologics Evaluation and Research
Allergenic Products Advisory Committee
3014512388
Blood Products Advisory Committee
3014519516
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Federal Register / Vol. 72, No. 107 / Tuesday, June 5, 2007 / Notices
Advisory Committee
31077
10–Digit Access Number
Cellular, Tissue & Gene Therapies Advisory Committee
3014512389
Transmissible Spongiform Encephalopathies Advisory Committee
3014512392
Vaccines and Related Biological Products Advisory Committee
3014512391
Center for Drug Evaluation and Research
Anesthetic and Life Support Drugs Advisory Committee
3014512529
Anti-Infective Drugs Advisory Committee
3014512530
Antiviral Drugs Advisory Committee
3014512531
Arthritis Advisory Committee
3014512532
Cardiovascular and Renal Drugs Advisory Committee
3014512533
Dermatologic and Ophthalmic Drugs Advisory Committee
3014512534
Drug Safety and Risk Management Advisory Committee
3014512535
Endocrinologic and Metabolic Drugs Advisory Committee
3014512536
Gastrointestinal Drugs Advisory Committee
3014512538
Nonprescription Drugs Advisory Committee
3014512541
Oncologic Drugs Advisory Committee
3014512542
Peripheral and Central Nervous System Drugs Advisory Committee
3014512543
Pharmaceutical Science & Clinical Pharmacology, Advisory Committee for (formerly Advisory Committee for
Pharmaceutical Science)
3014512539
Psychopharmacologic Drugs Advisory Committee
3014512544
Pulmonary-Allergy Drugs Advisory Committee
3014512545
Reproductive Health Drugs, Advisory Committee for
3014512537
Center for Food Safety and Applied Nutrition
Food Advisory Committee
3014510564
Center for Devices and Radiological Health
Device Good Manufacturing Practice Advisory Committee
3014512398
Medical Devices Advisory Committee (composed of 18 panels)
3014512624
Circulatory System Devices Panel
3014512625
Clinical Chemistry and Clinical Toxicology Devices Panel
3014512514
Dental Products Panel
3014512518
Ear, Nose, and Throat Devices Panel
3014512522
Gastroenterology-Urology Devices Panel
3014512523
General and Plastic Surgery Devices Panel
3014512519
General Hospital and Personal Use Devices Panel
3014512520
Hematology and Pathology Devices Panel
jlentini on PROD1PC65 with NOTICES
Anesthesiology and Respiratory Therapy Devices Panel
3014512515
Immunology Devices Panel
3014512516
Medical Devices Dispute Resolution Panel
3014510232
Microbiology Devices Panel
3014512517
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31078
Federal Register / Vol. 72, No. 107 / Tuesday, June 5, 2007 / Notices
Advisory Committee
10–Digit Access Number
Molecular and Clinical Genetics Panel
3014510231
Neurological Devices Panel
3014512513
Obstetrics-Gynecology Devices
3014512524
Ophthalmic Devices Panel
3014512396
Orthopaedic and Rehabilitation Devices Panel
3014512521
Radiological Devices Panel
3014512526
National Mammography Quality Assurance Advisory Committee
3014512397
Technical Electronic Product Radiation Safety Standards Committee
3014512399
Center for Veterinary Medicine
Veterinary Medicine Advisory Committee
3014512548
National Center for Toxicological Research (NCTR)
Science Advisory Board to NCTR
3014512559
The hotline will provide the most
recent information available on
upcoming advisory committee meetings,
guidance for making an oral
presentation during the open public
hearing portion of a meeting, and
procedures on obtaining copies of
transcripts of advisory committee
meetings. Because the hotline will
communicate the most current
information available about any
particular advisory committee meeting,
this system will provide interested
parties with timely and equal access to
such information. The hotline should
also conserve agency resources by
reducing the current volume of inquiries
individual FDA offices and employees
must handle concerning advisory
committee schedules and procedures.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: May 28, 2007.
Randall W. Lutter,
Associate Commissioner for Policy.
[FR Doc. E7–10738 Filed 6–4–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jlentini on PROD1PC65 with NOTICES
[Docket No. 2007D–0206]
Guidance for Industry: Refrigerated
Carrot Juice and Other Refrigerated
Low-Acid Juices; Availability
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance document
entitled ‘‘Guidance for Industry:
Refrigerated Carrot Juice and Other
Refrigerated Low-Acid Juices.’’ The
guidance sets forth the agency’s
recommendations for ensuring the
safety of refrigerated carrot juice and
other low-acid refrigerated juices. The
guidance is in response to six recent
cases of botulism poisoning linked to
refrigerated carrot juice that occurred in
the United States and Canada.
DATES: This guidance is final June 5,
2007. Submit written or electronic
comments on the guidance document at
any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Food Safety (HFS–317), Center
for Food Safety and Applied Nutrition,
5100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–2022, FAX: 301–
436–2651. Send one self-addressed
adhesive label to assist the office in
processing your requests. Submit
written comments on the guidance to
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Michael E. Kashtock, Center for Food
Safety and Applied Nutrition (HFS–
305), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
PO 00000
Frm 00029
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MD 20740, 301–436–2022, or e-mail:
michael.kashtock@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance document entitled
‘‘Guidance for Industry: Refrigerated
Carrot Juice and Other Refrigerated
Low-Acid Juices.’’ The purpose of the
document is to provide guidance that
will assist industry in processing and
labeling refrigerated carrot juice and
other refrigerated low-acid juices, which
are subject to the pathogen reduction
provisions of the Hazardous Analysis
and Critical Control Point regulation for
juice (21 CFR part 120) (the juice
HACCP regulation), in a manner
intended to provide for the safety of the
juice when offered for sale by the
processor and during handling by the
consumer after purchase. This guidance
is in response to six cases of botulism
poisoning linked to refrigerated carrot
juice that occurred in the United States
and Canada in September and October
2006. Clostridium botulinum is a
bacterium commonly found in soil.
Botulism is a rare but serious paralytic
illness caused by botulinum toxin, a
nerve poison that under certain
conditions is produced by C. botulinum.
Botulism can be fatal and is considered
a medical emergency. Foodborne
botulism is not common in the United
States.
FDA is issuing this guidance as level
1 guidance consistent with FDA’s good
guidance practices regulation (§ 10.115
(21 CFR 10.115)). Consistent with FDA’s
good guidance practices regulation, the
agency will accept comment, but is
implementing the guidance document
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]]>Agencies
[Federal Register Volume 72, Number 107 (Tuesday, June 5, 2007)]
[Notices]
[Pages 31076-31078]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10738]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee Information Hotline
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that we
have revised the Advisory Committee Information Hotline (the hotline).
The hotline provides the public with access to the most current
information available on FDA advisory committee meetings. This notice
supersedes all previously published announcements of the hotline.
FOR FURTHER INFORMATION CONTACT: Theresa L. Green, Committee Management
Officer (HF-4), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1220.
SUPPLEMENTARY INFORMATION: The hotline can be accessed by dialing 1-
800-741-8138 or 301-443-0572. The advisory committee meeting
information and information updates can also be accessed via FDA's
advisory committee calendar at https://www.fda.gov/oc/advisory/
accalendar/2007/default.htm.
Each advisory committee is assigned a 10-digit number. This 10-
digit number will appear in each individual notice of meeting. The
public can obtain information about a particular advisory committee
meeting by using the committee's 10-digit number. Information on the
hotline is preliminary and may change before a meeting is actually
held. The hotline will be updated when such changes are made. The
following is a list of each advisory committee's 10-digit number to be
used when accessing the hotline.
------------------------------------------------------------------------
Advisory Committee 10-Digit Access Number
------------------------------------------------------------------------
Office of the Commissioner
------------------------------------------------------------------------
Pediatric Advisory Committee 8732310001
------------------------------------------------------------------------
Risk Communication Advisory Committee 8732112560
------------------------------------------------------------------------
Science Board to the FDA 3014512603
------------------------------------------------------------------------
Center for Biologics Evaluation and Research
------------------------------------------------------------------------
Allergenic Products Advisory Committee 3014512388
------------------------------------------------------------------------
Blood Products Advisory Committee 3014519516
------------------------------------------------------------------------
[[Page 31077]]
Cellular, Tissue & Gene Therapies Advisory 3014512389
Committee
------------------------------------------------------------------------
Transmissible Spongiform Encephalopathies 3014512392
Advisory Committee
------------------------------------------------------------------------
Vaccines and Related Biological Products 3014512391
Advisory Committee
------------------------------------------------------------------------
Center for Drug Evaluation and Research
------------------------------------------------------------------------
Anesthetic and Life Support Drugs Advisory 3014512529
Committee
------------------------------------------------------------------------
Anti-Infective Drugs Advisory Committee 3014512530
------------------------------------------------------------------------
Antiviral Drugs Advisory Committee 3014512531
------------------------------------------------------------------------
Arthritis Advisory Committee 3014512532
------------------------------------------------------------------------
Cardiovascular and Renal Drugs Advisory 3014512533
Committee
------------------------------------------------------------------------
Dermatologic and Ophthalmic Drugs Advisory 3014512534
Committee
------------------------------------------------------------------------
Drug Safety and Risk Management Advisory 3014512535
Committee
------------------------------------------------------------------------
Endocrinologic and Metabolic Drugs 3014512536
Advisory Committee
------------------------------------------------------------------------
Gastrointestinal Drugs Advisory Committee 3014512538
------------------------------------------------------------------------
Nonprescription Drugs Advisory Committee 3014512541
------------------------------------------------------------------------
Oncologic Drugs Advisory Committee 3014512542
------------------------------------------------------------------------
Peripheral and Central Nervous System 3014512543
Drugs Advisory Committee
------------------------------------------------------------------------
Pharmaceutical Science & Clinical 3014512539
Pharmacology, Advisory Committee for
(formerly Advisory Committee for
Pharmaceutical Science)
------------------------------------------------------------------------
Psychopharmacologic Drugs Advisory 3014512544
Committee
------------------------------------------------------------------------
Pulmonary-Allergy Drugs Advisory Committee 3014512545
------------------------------------------------------------------------
Reproductive Health Drugs, Advisory 3014512537
Committee for
------------------------------------------------------------------------
Center for Food Safety and Applied Nutrition
------------------------------------------------------------------------
Food Advisory Committee 3014510564
------------------------------------------------------------------------
Center for Devices and Radiological Health
------------------------------------------------------------------------
Device Good Manufacturing Practice 3014512398
Advisory Committee
------------------------------------------------------------------------
Medical Devices Advisory Committee (composed of 18 panels)
------------------------------------------------------------------------
Anesthesiology and Respiratory Therapy 3014512624
Devices Panel
------------------------------------------------------------------------
Circulatory System Devices Panel 3014512625
------------------------------------------------------------------------
Clinical Chemistry and Clinical 3014512514
Toxicology Devices Panel
------------------------------------------------------------------------
Dental Products Panel 3014512518
------------------------------------------------------------------------
Ear, Nose, and Throat Devices Panel 3014512522
------------------------------------------------------------------------
Gastroenterology-Urology Devices Panel 3014512523
------------------------------------------------------------------------
General and Plastic Surgery Devices 3014512519
Panel
------------------------------------------------------------------------
General Hospital and Personal Use 3014512520
Devices Panel
------------------------------------------------------------------------
Hematology and Pathology Devices Panel 3014512515
------------------------------------------------------------------------
Immunology Devices Panel 3014512516
------------------------------------------------------------------------
Medical Devices Dispute Resolution Panel 3014510232
------------------------------------------------------------------------
Microbiology Devices Panel 3014512517
------------------------------------------------------------------------
[[Page 31078]]
Molecular and Clinical Genetics Panel 3014510231
------------------------------------------------------------------------
Neurological Devices Panel 3014512513
------------------------------------------------------------------------
Obstetrics-Gynecology Devices 3014512524
------------------------------------------------------------------------
Ophthalmic Devices Panel 3014512396
------------------------------------------------------------------------
Orthopaedic and Rehabilitation Devices 3014512521
Panel
------------------------------------------------------------------------
Radiological Devices Panel 3014512526
------------------------------------------------------------------------
National Mammography Quality Assurance 3014512397
Advisory Committee
------------------------------------------------------------------------
Technical Electronic Product Radiation 3014512399
Safety Standards Committee
------------------------------------------------------------------------
Center for Veterinary Medicine
------------------------------------------------------------------------
Veterinary Medicine Advisory Committee 3014512548
------------------------------------------------------------------------
National Center for Toxicological Research (NCTR)
------------------------------------------------------------------------
Science Advisory Board to NCTR 3014512559
------------------------------------------------------------------------
The hotline will provide the most recent information available on
upcoming advisory committee meetings, guidance for making an oral
presentation during the open public hearing portion of a meeting, and
procedures on obtaining copies of transcripts of advisory committee
meetings. Because the hotline will communicate the most current
information available about any particular advisory committee meeting,
this system will provide interested parties with timely and equal
access to such information. The hotline should also conserve agency
resources by reducing the current volume of inquiries individual FDA
offices and employees must handle concerning advisory committee
schedules and procedures.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: May 28, 2007.
Randall W. Lutter,
Associate Commissioner for Policy.
[FR Doc. E7-10738 Filed 6-4-07; 8:45 am]
BILLING CODE 4160-01-S
