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Reset Form Form Approved: OMB No. 0910-0027. Expiration Date: November 30, 2007. See Reverse. FOR FDA USE ONLY
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION College Park, MD 20740-3835
REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENT
(In accordance with 21 CFR 710)
NOTE: This report is authorized by Public Law 21 U.S.C. 371(A); 21 CFR 710. While you are not required to respond, your cooperation is needed to make the results of this voluntary program comprehensive, accurate, and timely. TYPE OF SUBMISSION (CHECK ONE) ORIGINAL AMENDMENT
(If this is an amended submission enter Registration Number)
ALL CARDS
REGISTRATION NO. E E
CANCELLATION
ESTABLISHMENT NAME (12 - 46) CARD NO.
(9 - 11)
110
KIND OF BUSINESS (47 - 48) MANUFACTURER PACKER
AF NO. (86 - 72)
REGISTRATION DATE (73 - 80)
NAME OF PARENT COMPANY (If any) (12 - 46) 111
STREET ADDRESS (12 - 46) 112
CITY (12 - 36) 113
STATE (37 - 38) ZIP CODE (39 - 43)
COUNTRY (If other than USA) (44 -72)
(12 - 13)
OTHER BUSINESS TRADING NAMES (14 - 48)
TYPE OF ACTION (48 - 72)
01
02
03 220 04
05
06 TYPED NAME AND TITLE OF AUTHORIZED INDIVIDUAL DATE COMPLETED (73-80)
SIGNATURE BLOCK
SIGNATURE OF AUTHORIZED INDIVIDUAL
FORM FDA 2511 (6/06)
PREVIOUS EDITION IS OBSOLETE.
PAGE ____ OF ____ PAGES
PSC Graphics: (301) 443-1090
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INSTRUCTIONS FOR COMPLETING FORM FDA 2511 Complete the form as described below. Indicate the type of submission by checking the appropriate box. Items not covered in these Instructions are self-explanatory. Type all entries in CAPITAL LETTERS. Use standard abbreviations wherever possible. Omit all punctuation. Complete a separate Form FDA 2511 for each establishment location. Leave completed and signed form intact and forward to: DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION Office of Cosmetics and Colors Voluntary Cosmetic Registration Program (HFS-125) 5100 Paint Branch Parkway College Park, MD 20740-3835 SPECIFIC INSTRUCTIONS CARD NO(S) ALL COLUMN NO(S) 1-8 ITEM REGISTRATION NUMBER. This number will be assigned by FDA. Firms having more than one location will have a different number for each location. This number will appear on the validated copy which is returned to the establishment. (Correspondence with FDA concerning this Registration must reference the Registration Number.) ESTABLISHMENT NAME. Enter the name under which the establishment is to be registered at this one general physical location under one management. KIND OF BUSINESS. Check appropriate box or combination of boxes. NAME OF PARENT COMPANY (if any). A second line has been provided for the name of the parent company of the establishment as shown in the example in CARD 110, Columns 12-46. STREET ADDRESS. Enter establishment physical street location. A P.O. Box number may only be added as additional information for postal communications. STATE. Use Official Post Office 2 letter State Code. OTHER BUSINESS TRADING NAMES. Defined as subsidiary or related firm names used on a cosmetic product label, which are owned by the cosmetic manufacturer or packer, but different from the principal name under which the cosmetic product manufacturer or packer is registering or is registered. If you require more than 6 Other Business Trading Names, use a second form. Complete entries in CARD 110, Columns 12-46; CARD 112, Columns 12-46; CARD 113, Columns 12-72; then continue to enter Other Business Trading Names in CARD 220, Columns 14-48. Also, complete pagination at bottom of the form when there are more than 6 Other Business Trading Names. INSTRUCTIONS FOR AMENDED OR CANCELLED SUBMISSIONS
Changes in the information on a validated Form FDA 2511 must be entered on a NEW Form FDA 2511 as an AMENDMENT within 30 days of such changes. This includes notification to cancel the registration or to delete any part of the information in the original file. Check the amended or cancelled Submission box at the top of the form and enter the Registration Number in the place provided. (The Registration Number is found in the upper right corner of the validated copy and must be entered exactly as it appears including the leading zeros.)
110
12-46 47-48
111 112 113 220
12-46 12-46 37-38 14-48
CANCELLATION OF REGISTRATION
When Establishment no longer conducts business under this name or when Establishment name is changed, complete: Type of Submission. Check CANCELLATION box. CARD 110, Columns 12-46 Signature Block
CHANGE OF ADDRESS
Self-explanatory. Complete: Type of Submission. Check AMENDMENT box. CARD 110, Columns 12-46 CARD 112, Columns 12-46 CARD 113 Signature Block
ADDITIONS OR DELETIONS TO OTHER BUSINESS TRADING NAMES
Any change in Other Business Trading Name is handled as either an addition or deletion. Describe Type of Action as either ADD or DELETE. Complete: Type of Submission. Check AMENDMENT box. CARD 110, Columns 12-46 CARD 220, one or more items, ALL Columns Signature Block
Public reporting burden for this collection of information is estimated to average 25 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to:
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION Office of Cosmetics and Colors Voluntary Cosmetic Registration Program (HFS-125) 5100 Paint Branch Parkway College Park, MD 20740-3835
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.