Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is considering whether to revise its regulations pertaining to export notification and recordkeeping. FDA has received a petition for reconsideration claiming that the agency lacks legal authority to inspect export records held by food and cosmetic companies. The petition also claimed that the regulations describing the types of records that should be kept to demonstrate that an exported product does not conflict with the foreign country's laws are overly burdensome. FDA is inviting comment on the issues raised by the petition.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 1 [Docket No. 1998N-0583] AGENCY: Food and Drug Administration, HHS. ACTION: Advance notice of proposed rulemaking. SUMMARY: The Food and Drug Administration (FDA) is considering whether to revise its regulations pertaining to export notification and recordkeeping. FDA has received a petition for reconsideration claiming that the agency lacks legal authority to inspect export records held by food and cosmetic companies. The petition also claimed that the regulations describing the types of records that should be kept to demonstrate that an exported product does not conflict with the foreign country's laws are overly burdensome. FDA is inviting comment on the issues raised by the petition. DATES: Submit written or electronic comments by August 16, 2004. ADDRESSES: You may submit comments, identified by Docket No. 1998N-0583, by any of the following methods: Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting comments. Agency Web site: http://www.fda.gov/​dockets/​ecomments . Follow the instructions for submitting comments on the agency Web site. E-mail: fdadockets@oc.fda.gov . Include Docket No. 1998N-0583 in the subject line of your e-mail message. FAX: 301-827-6870. Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions : All submiss…
Citation: 69 FR 30842