Form Fda 2657
Notices: Agency Information Collection Activities; Proposals ...
FR Doc E9-108 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Docket ID: [Docket No. FDA-2005-N-0464] (formerly Docket No. 2005N-0403)
NOTICE: NOTICES DOCID: fr08ja09-37 DOCUMENT ACTION: Notice. SUBJECT CATEGORY:Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing
DATES: Fax written comments on the collection of information by February 9, 2009. DOCUMENT SUMMARY: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.
SUMMARY:Agency Information Collection Activities; Proposals, Submissions, and Approvals
SUPPLEMENTAL INFORMATION
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Draft Guidance for Industry on Providing Regulatory Submissions in Electronic FormatDrug Establishment Registration and Drug Listing; Availability; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution(OMB Control Number 09100045Amendment)
Description of Respondents: Respondents to this collection of information are foreign and domestic owners and operators of establishments that engage in the manufacture, preparation, propagation, compounding, or processing (which includes, among other things, repackaging and relabeling) of a drug or drugs\1\ and that are not exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act (the act) or subpart B of part 207 (21 CFR part 207) (registrants). \1\ Means both human, including biological products, and animal drugs.
A. Reporting BurdenThe draft guidance describes how to electronically create and submit Structured Product Labeling (SPL) files using defined code sets and codes for establishment registration and drug listing information (including labeling). Most information is already required to be submitted under section 510 of the act, section 351 of the Public Health Service Act, and part 207.
Drug establishment registration and drug listing information and updates to such information, required under part 207, and certain additional recommended information are currently submitted in paper form using Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments Report of Private Label Distributors) (collectively referred to as FDA Forms; 72 FR 67733, November 30, 2007).
Form Fda 2657 - Bookshelf
Code of Federal Regulations, Title 21, Food and Drugs, Pt. 200-299, Revised as of April 1, 2010
(b) The first list of drugs and later June and December updatings shall be on Form FDA-2657 (Drug Product Listing), obtainable upon request as described in ...Code of Federal Regulations, Title 21, Food and Drugs, Pt. 200-299, Revised as of April 1, 2009
An establishment may submit, in lieu of Form FDA-2657, tapes for computer inputs containing the information specified in Form FDA-2657 if formats proposed ...Code of Federal Regulations Title 21, Food And Drugs 2005
An establishment may submit, in lieu of Form FDA-2657, tapes for computer inputs containing the information specified in Form FDA-2657 if formats proposed ...Food, drug, cosmetic law reporter
(b) The first list of drugs and later June and December updatings shall be on Form FDA-2657 (Drug Product Listing), obtainable upon request as described in ...Validation Compliance Annual, 1995
(iii) Withdrawal of approved drug product from sale, (a) The applicant shall submit on Form FDA 2657 (Drug Product Listing), within 15 working days of the ...Day-by-day News Directory
Electronic Drug Registration and Listing Instructions
... now, been submitted using a paper-based format, i.e., Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 ...
Document
Form FDA–2657 (Drug Product Listing). (c) It is requested but not required. that a ... FDA will provide to the registrant. a validated copy of Form FDA–2656 ...
SUPPORTING STATEMENT REGISTRATION OF PRODUCERS OF DRUGS AND ...
Form FDA-2656 (Registration of Drug Establishment) within 5 ... required on Form FDA-2657, FDA may also require, under. § 207.31, a copy of all advertisements and a quantitative ...
CFR - Code of Federal Regulations Title 21
An establishment may submit, in lieu of Form FDA-2657, tapes for computer inputs containing the information specified in Form FDA-2657 if formats ...
CFR - Code of Federal Regulations Title 21
Form FDA-2253 is available on the Internet athttp://www.fda.gov ... (b ) The applicant shall submit each Form FDA-2657 to the Records Repository Team (HFD-143), Center for Drug ...