Department of Health and Human Services July 7, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
Determination That ACCUTANE (Isotretinoin) Capsules, 10 Milligrams, 20 Milligrams, and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) is announcing its determination that ACCUTANE (isotretinoin) Capsules, 10 milligrams (mg), 20 mg, and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Determination That ACTONEL (Risendronate Sodium) Tablets, 75 Milligrams, and ACTONEL WITH CALCIUM (Risendronate Sodium and Calcium Carbonate (Copackaged)) Tablets, 35 Milligrams/500 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) is announcing the determination that ACTONEL (risendronate sodium) Tablets, 75 milligrams (mg), and ACTONEL WITH CALCIUM (risendronate sodium and calcium carbonate (copackaged)) Tablets, 35 mg/500 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for these products, if all other legal and regulatory requirements are met.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).
Submission for OMB Review; Comment Request; Survey of Health Care Professionals' Awareness and Perceptions of the National Cancer Institute's Intramural Clinical Trials (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on April 22, 2010 (75 FR 20999) and allowed 60-days for public comment. There were no public comments received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Disclosure of Nutrient Content Information for Standard Menu Items Offered for Sale at Chain Restaurants or Similar Retail Food Establishments and for Articles of Food Sold From Vending Machines
The Food and Drug Administration (FDA) is announcing the opening of a docket to solicit comments, data, and other information helpful to the implementation of section 4205 of the Patient Protection and Affordable Care Act of 2010, which was enacted on March 23, 2010. That section, principally amending sections 403 and 403A of the Federal Food, Drug, and Cosmetic Act (the act), requires chain restaurants and similar retail food establishments with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to disclose nutrient content information for standard menu items appearing on restaurant menus and menu boards, and requires vending machine operators that own or operate 20 or more vending machines to disclose nutrient content information for certain articles of food sold from vending machines. Section 4205 also amended the act to allow restaurants or similar retail food establishments and operators of vending machines not subject to the requirements of section 4205 to elect to be subject to the requirements through biannual registration. FDA is establishing this docket to provide an opportunity for interested parties to submit data and other information relevant to the implementation of section 4205.
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