Agency: Food and Drug Administration
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[FR Doc E9-23521] 51. Agency Information Collection Activities; Submission for Office of Management
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.
Published: 2009-09-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-23144] 52. Enforcement of General Tobacco Standard Special Rule for Cigarettes
The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), establishes a tobacco standard special rule for cigarettes. This special rule for cigarettes prohibits a cigarette or any of its component parts (including the tobacco, filter, or paper) from containing, as a
Published: 2009-09-25 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-22850] 53. Current Good Manufacturing Practice Requirements for Combination Products
The Food and Drug Administration (FDA or agency) proposes to codify the current good manufacturing practice (cGMP) requirements applicable to combination products. This proposed rule is intended to promote the public health by clarifying which cGMP requirements apply when drugs, devices, and biological products are combined to create a
Published: 2009-09-23 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-22380] 54.Draft Guidance for Industry on Microbiological Data for Systemic Antibacterial
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled
``Microbiological Data for Systemic Antibacterial Drug Products
Development, Analysis, and Presentation.'' The draft guidance informs industry of FDA's current thinking regarding the types of
microbiological studies, assessments, and clinical
Published: 2009-09-17 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-22008] 55. National Fisheries Institute; Filing of Food Additive Petition; Amendment
The Food and Drug Administration (FDA) is amending the [[Page 47593]]
filing notice for a food additive petition filed by the National
Fisheries Institute, to provide for the safe use of ionizing radiation
for control of foodborne pathogens in crustaceans and processed
crustaceans.
Published: 2009-09-16 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-22121] 56. Agency Information Collection Activities; Submission for Office of Management
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.
Published: 2009-09-15 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-22120] 57. Agency Emergency Processing Under the Office of Management and Budget Review;
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of September 1, 2009 (74 FR 45219). The document announced the proposed collection of information concerning the submission of tobacco product establishment registration and submission of certain health information, including ingredient listing and
Published: 2009-09-15 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-22001] 58. Memorandum of Understanding With Duke University
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration and Duke University. The purpose of this MOU is to establish a framework for collaboration between the Parties and for pursuing specific collaborative projects. This collaboration between the Parties shall be
Published: 2009-09-14 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-21724] 59. Agency Information Collection Activities; Proposed Collection; Comment
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
Published: 2009-09-09 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-21558] 60. Request for Nominations for Voting and Nonvoting Consumer Representative
The Food and Drug Administration (FDA) is requesting nominations for voting and nonvoting consumer representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) and certain devices panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health (CDRH).
FDA has a special
Published: 2009-09-09 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-21364] 61. Agency Information Collection Activities; Submission for Office of Management
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.
Published: 2009-09-04 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-21302] 62. Report on the Performance of Drug and Biologics Firms in Conducting
Under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), the Food and Drug Administration (FDA) is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon, by holders of approved drug and biological products. This is the agency's
Published: 2009-09-04 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-21026] 63. Agency Information Collection Activities; Submission for Office of Management
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.
Published: 2009-09-01 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-21097] 64. Agency Information Collection Activities; Announcement of Office of
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Importer's Entry Notice'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2009-09-01 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-21099] 65. Agency Emergency Processing Under Office of Management and Budget Review;
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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the submission of tobacco product establishment registration and
Published: 2009-09-01 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-20856] 66. Egg Safety; Final Rule for Prevention of Salmonella Enteritidis in Shell Eggs
The Food and Drug Administration (FDA) is announcing two public meetings to discuss the final rule concerning the prevention of Salmonella Enteritidis (SE) in shell eggs during production, storage, and transportation. The purpose of the public meetings is to explain the requirements of the rule and how to comply with it, and to provide the
Published: 2009-08-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-20895] 67. Agency Information Collection Activities; Announcement of Office of
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2009-08-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-20634] 68. Memorandum of Understanding Between the Food and Drug Administration,
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Air Force Research Laboratory. This Memorandum of Understanding (MOU) between the Food and Drug Administration, National Center for Toxicological Research (NCTR), and the Air Force Research Laboratory, 711 Human Performance Wing,
Published: 2009-08-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-20553] 69. Defining ``Small Number of Animals'' for Minor Use Designation
The designation provision of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives to animal drug sponsors to encourage drug development and approval for minor species and for minor uses in major animal species. Congress provided a statutory definition of ``minor use'' that relied on the phrase ``small number of
Published: 2009-08-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-20485] 70. Advisory Committee; Tobacco Products Scientific Advisory Committee;
The Food and Drug Administration (FDA) is announcing the Establishment of the Tobacco Products Scientific Advisory Committee. These actions are needed to implement the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act. Elsewhere in this issue of the Federal Register, FDA is publishing two
Published: 2009-08-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-20495] 71. Acrylamide in Food; Request for Comments and for Scientific Data and
The Food and Drug Administration (FDA) is requesting comments and scientific data and information on acrylamide in food. Acrylamide is a chemical that can form in some foods during certain types of high temperature cooking. FDA is seeking information on practices that manufacturers have used to reduce acrylamide in food and the reductions they have
Published: 2009-08-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-20483] 72. Request for Notification From Industry Organizations Interested in
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on its Tobacco Products Scientific Advisory Committee notify FDA in writing. A nominee may either be selfnominated or nominated by an organization to serve as a nonvoting
Published: 2009-08-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-20407] 73. Agency Information Collection Activities; Proposed Collection; Comment
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
Published: 2009-08-25 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-20409] 74. Agency Information Collection Activities; Proposed Collection; Comment
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
Published: 2009-08-25 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-20247] 75. Agency Information Collection Activities; Proposed Collection; Comment
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
Published: 2009-08-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
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