FDA's Continuing Failure to Regulate Health Claims for Foods: Hearings Before the Human Resources and Intergovernmental Relations Subcommittee of the Committee on Government Operations, House of Representatives, One Hundred First Congress, First Session, October 31 and November 9, 1989, Volume 4
United States. Congress. House. Committee on Government Operations. Human Resources and Intergovernmental Relations Subcommittee
U.S. Government Printing Office, 1990 - Advertising - 524 pages
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Page 284 - A person outside the executive branch may invite an agency representative to attend or participate in a meeting outside agency offices. The agency representative is not obligated to attend or participate, but may do so where it is in the public interest and will promote the objectives of the act. (2) The agency representative may request that the meeting be open if that would be in the public interest. The agency representative may decline to participate in a meeting held as a private meeting if...
Page 284 - FDA employees have a responsibility to meet with all segments of the public to promote the objectives of the laws administered by the Agency. In pursuing this responsibility the following general policy applies where agency employees are invited by persons outside the Federal Government to attend or participate in meetings outside agency offices as representatives of the Agency. (1) A person outside the executive branch may invite an agency representative to attend or participate in a meeting outside...
Page 258 - Two copies of any comments 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 Received comments may be seen In the office above between 9 am and 4 pm.
Page 282 - ... agency action" includes the whole or a part of an agency rule, order, license, sanction, relief, or the equivalent or denial thereof, or failure to act; and (14) "ex parte communication" means an oral or written communication not on the public record with respect to which reasonable prior notice to all parties is not given, but it shall not include requests for status reports on any matter or proceeding covered by this subchapter.
Page 282 - Administrative action includes every act, including the refusal or failure to act, involved in the administration of any law by the Commissioner, except that it does not include the referral of apparent violations to US attorneys for the institution of civil or criminal proceedings or an act in preparation of a referral. Administrative file means the file or files containing all documents pertaining to a particular administrative action, including internal working memoranda, and recommendations....
Page 384 - ... (B) the cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substance or substances in such diet; and (C) safety factors which in the opinion of experts qualified by scientific training and experience to evaluate the safety of food additives are generally recognized as appropriate for the use of animal experimentation data.
Page 283 - FDA representative in all cases. (c) A meeting with a person outside the Department, including a person in the executive or legislative branch of the Federal Government, concerning a pending court case, administrative hearing, or other regulatory action or decision, which involves more than a brief description of the matter, is to be summarized in a written memorandum, which is filed in the administrative file on the matter.
Page 282 - Dockets Management Branch" means the Dockets Management Branch, Office of Management and Operations of the Food and Drug Administration, US Department of Health and Human Services, Room 462, 5600 Fishers Lane, Rockville, MD 20857. "Ex parte communication...
Page 284 - Government on any matter concerning the laws administered by the Commissioner. (DA meeting initiated by FDA representatives which involves a small number of interested persons, for example, a meeting with a petitioner or with two manufacturers of a particular product which requires additional testing or with a trade association employee to discuss an industry labeling problem, may be a private meeting. A meeting initiated by FDA representatives which involves a large number of interested persons,...