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RULES: Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition,
Published: 2008-07-03
The Food and Drug Administration (FDA) is issuing an order
prohibiting the extralabel use of cephalosporin antimicrobial drugs in
foodproducing animals. We are issuing this order based on evidence
that extralabel use of these drugs in foodproducing animals will
likely cause an adverse event in humans and, as such, presents a risk
to the public
NOTICES: Submission of Quality Information for Biotechnology Products in the Office of Biotechnology Products; Notice of Pilot Program,
Published: 2008-07-02
The Food and Drug Administration (FDA) is seeking volunteers from pharmaceutical companies to participate in a pilot
[[Page 37973]]
program involving the submission of quality (chemistry, manufacturing,
and controls) information for biotechnology products in an Expanded
Change Protocol, consistent with the principles of quality by design
and risk
NOTICES: Danisco USA, Inc.; Correction,
Published: 2008-07-02
The Food and Drug Administration (FDA) is correcting a
document announcing the withdrawal, without prejudice to a future
filing, of a food additive petition (FAP 6A3958) that appeared in the
Federal Register of June 20, 2008. FDA is correcting the addresses of
both Pfizer, Inc., and Danisco USA, Inc.
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-07-01
The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Request for Designation as Country
not Subject to the Restrictions Applicable to Human Food and Cosmetics
Manufactured from, Processed With, or Otherwise Containing, Material
from Cattle'' has been approved by the Office of Management and Budget
(OMB)
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-07-01
The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-07-01
The Food and Drug Administration (FDA) is announcing [[Page 37466]]
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
NOTICES: Innovative Food Defense Projects; New Limited Competition Cooperative Agreement (U13),
Published: 2008-07-01
The Food and Drug Administration (FDA), Office of Regulatory
Affairs (ORA), Division of FederalState Relations (DFSR) is announcing
the availability of grant funds for the support of innovative food
defense projects. These grants are available to State, local, and
tribal levels and must have national implication or application that
can enhance
NOTICES: Cooperative Agreement to Establish and Support the Western Center for Food Safety (U01),
Published: 2008-06-30
The Food and Drug Administration (FDA) is announcing a Request
for Application (RFA) Number RFAFD08004 and its intention to receive
and consider a new sole source application for the award of a
cooperative agreement in fiscal year 2008 (FY 2008) to establish and
support the Western Center for Food Safety (WCFS). The WCFS will be
located at the
NOTICES: Availability of an Agreement of Limited Competition, etc.,
Published: 2008-06-30
I. Research Objectives
The Food and Drug Administration (FDA), Office of Regulatory
Affairs (ORA), Division of FederalState Relations (DFSR) in
collaboration with the Center for Food Safety and Applied Nutrition
(CFSAN) and Center for Veterinary Medicine (CVM), is announcing the
availability of an Agreement of Limited Competition. Only States
NOTICES: Prescription Drug User Fee Act IV Information Technology Plan,
Published: 2008-06-30
The Food and Drug Administration (FDA) is announcing the
availability of the information technology (IT) Plan entitled
``Prescription Drug User Fee Act (PDUFA) IV Information Technology
Plan'' to achieve the objectives defined in the PDUFA Performance
Goals. This plan is intended to provide regulated industry and other
stakeholders with
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-06-27
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-06-27
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-06-27
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-06-27
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-06-26
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
NOTICES: Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee,
Published: 2008-06-26
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Name of Committee: Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the
NOTICES: Microbiological Considerations for Antimicrobial Food Additive Submissions; Availability,
Published: 2008-06-25
The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Guidance for
Industry: Microbiological Considerations for Antimicrobial Food
Additive Submissions.'' The guidance explains FDA's current thinking on
a number of microbiological issues unique to the preparation of
premarket submissions for
RULES: Oral Dosage Form New Animal Drugs; Sulfachlorpyridazine Powder,
Published: 2008-06-24
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Fort Dodge Animal Health, A Division of
Wyeth Holdings Corp. The supplemental NADA provides for a revised food
safety warning statement for oral use of sulfachlorpyridazine in the
milk or
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-06-24
The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-06-24
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
RULES: Medical Devices; Change of Name; Technical Amendment,
Published: 2008-06-23
The Food and Drug Administration (FDA) is amending its
regulations to implement a nomenclature change and to ensure accuracy
and clarity in the agency's regulations.
RULES: Change of Sponsors Drug Labeler Code,
Published: 2008-06-23
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor's drug labeler code for
ADM Alliance Nutrition, Inc. This action is being taken to improve the
accuracy of the regulations.
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-06-23
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
NOTICES: Determination of Regulatory Review Period for Purposes of Patent Extension; ERAXIS,
Published: 2008-06-23
The Food and Drug Administration (FDA) has determined the
regulatory review period for ERAXIS and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which
NOTICES: Danisco USA, Inc.; Withdrawal of Food Additive Petition,
Published: 2008-06-20
The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a
[[Page 35143]]
future filing, of a food additive petition (FAP 6A3958) proposing that
the food additive regulations be amended to provide for the safe use of
alitame as a sweetening agent or flavoring in food.