Form FDA 2567 FDA 2567 Transmittals of Labels and Circulars

Form Approved; OMB No. 0910-0338. Expiration Date: August 31, 2005 See OMB statement on reverse.
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH TRANSMITTAL OF LABELS AND CIRCULARS						1. LABEL REVIEW NO. AND REVISION
						     
						2. CHECK ONE
						Draft Final (in distribution)
NOTE: No license may be granted unless this completed submittal form has been received (U.S. Public Health Service Act, Section 351; the Federal Food, Drug, and Cosmetic Act, Section 502; and Title 21 U.S. Code of Federal Regulations, Part 600).
3. MANUFAC- TURER NAME AND RETURN ADDRESS			     								4. LICENSE NO.
											     
											5. REGISTRATION NO.
											     
6. PRODUCT NAME			     
7. LABELING LABEL TYPE CODE REPLACES PREVIOUS LABEL DETAILS (see below) REVIEW & REVISION NO. DATE								8. SUBMISSION REASONS (Check all that apply) New Product New Scientific Information New Indication Editorial, Format Contraindications, Dosage Change Adverse Reactions, Precautions Manufacturing New Formulation Method Change Anticoagulant/ Other (Specify in Additive Change Comments)
				     	     
	LABEL TYPE CODES (select only one) CIRC Circular DILT Diluent PCKR Packer CONT Container BLST Blister SHIP Shipping PACK Package CRTN Carton BULK Bulk OTHR Other (Specify in Comments)
9. CHECK THE BOX(es) INDICATING FORMAT OF THIS SUBMISSION (More than one may be checked.) Paper Electronic
10. CHECK BOX IF THIS LABELING IS IN SUPPORT OF: Application Supplement Part of an Annual Report										Associated BLA/ PLA No. Report
										     
11. COMMENTS (Include any Manuf. ID number, description or revision no. of label being replaced. IF FINAL PRINTED, provide LOT NO. & DATE of FIRST USE.)
     
12. AUTHORIZED OFFICIAL		SIGNATURE								DATE
										     
THE SPACES BELOW ARE FOR USE BY CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
COMMENTS (See attached comments )
     
REVIEWED BY		SIGNATURE							DATE
									     
RETURNED BY		SIGNATURE							DATE
									     

GENERAL INSTRUCTIONS FOR COMPLETING FORM FDA 2567

Type or print legibly in ink. Submit three copies of preliminary proofs and drafts. For revised labeling, indicate where changes
have been made on the labeling copy. Assemble and staple each set, including attachments. Submit each type of labeling
(carton, container, insert, etc.) with a Form FDA 2567. The transmittal form should be dated and signed by the authorized
official. Send to the Food and Drug Administration, Center for Biologics Evaluation and Research (CBER), HFM-99, 1401
Rockville Pike, Rockville, Maryland 20852-1448. Either Form FDA 2567 or Form FDA 2253 may be used for submissions of
advertising and promotional labeling. Send to the above address and reference the mail code HFM-602.

INSTRUCTIONS FOR COMPLETING NUMBERED ITEMS ON FORM FDA 2567

1. If this is the initial submission for a new or revised label, leave blank and FDA will assign a number. If this is a
resubmission of pending labeling, you may include the previously assigned number.

2. Check the draft box if this is a revised draft or a final draft label. Check the final box if item is final printed labeling that has been distributed.

3. Enter the manufacturer’s name and complete address where the review comments should be returned.

4. If establishment is licensed, enter license number.

5. Enter the registration number that will appear on the label for blood and blood components for submissions that are directed to the Office of Blood Research and Review. This field should be left blank for other product submissions.

6. Enter the proper name (e.g. established or United States Adopted Name) followed by the trade name, if any, for the product.

7. For LABEL TYPE CODE, select only ONE label type and enter into the box. Multiple labels may be submitted under each Form 2567 although all must be of the same type and product. Each label type requires an additional form. For REVIEW AND REVISION NO., if Form 2567 applies to an initial submission or revised labeling submitted under 21 CFR 601.12, complete the REPLACES PREVIOUS LABEL box with the most recent marketed labeling of this type and the date it was returned by CBER. If form applies to a resubmission of pending labeling and the FDA has already assigned this number, complete the box with revision number indicated on the copy of the Form 2567 that FDA returned to company, and the date FDA signed the REVIEWED BY date box. The REPLACES PREVIOUS LABEL boxes do not apply to labeling for brand new products.

8. Check the box that best applies to your current submission. The Anticoagulant/Additive Change applies only to submis-sions directed to the Office of Blood Research and Review.

9. Check the applicable box(es). If any part of the labeling is on diskette, CD, or other electronic media, the electronic box
should be checked.

10. Check one of the boxes if this labeling is associated with or in support of an original application, supplement, or annual
report and enter the reference or submission tracking number in the Associated BLA/PLA No. box.

11. Complete with any comments that are important for the review, including manufacturer ID number(s), description or
revision numbers of labels being replaced, submission reason not covered in checklist in item number 8, label type code not included in item number 7, etc. If this is FINAL LABELING that has been distributed, provide the lot number and the date of distribution in this space.

12. An authorized official signs his/her name in this space followed by the date that the labeling is being submitted to CBER.

Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and 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

CBER, HFM-99

1401 Rockville Pike

Rockville, MD 20852-1488

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.

FORM FDA 2567 (2/05) PREVIOUS EDITION IS OBSOLETE. FRONT

PSC Media Arts (301) 443-1090 EF