FDA IND, NDA, ANDA, or Drug Master File Binders

REQUIRED SPECIFICATIONS FOR FDA’s
IND, NDA, ANDA, DRUG MASTER FILE BINDERS

Binders (covers) can be ordered on line from the U.S. Government Printing Office (GPO) Web site: http://bookstore.gpo.gov/ by searching for the appropriate form or by calling 202-512-1800 to speak with a GPO customer service representative.

If you have any questions or need additional information regarding the use of the binders , please contact FDA via druginfo@fda.hhs.gov.

Binders that are not ordered from the GPO must meet the following requirements:

POLYETHYLENE BINDERS -

Front (flat size) - 248 x 292mm (9-3/4 x 11-1/2")
Back (flat size) - 248 x 305mm (9-3/4 x 12") (size includes 13 mm (1/2") lip at top)

Must be high impact linear plastic (matte finish or similar) - Must be able to withstand temperatures up to 150 degrees - Material should have a surface smooth enough to allow printing with a complete bonding of ink to the surface after a minimum of one hour drying time - Should be free from streaks, blisters, scratches and mottling -

Binder weight MUST be .023-.025 gauge - Ink color MUST be BLACK -

Polyethylene Binders include -

FDA Form 2626 - Blue - NDA ARCHIVAL BINDER
FDA Form 2675 - Red - IND ARCHIVAL BINDER
FDA Form 3316 - Red - DRUG MASTER FILE BINDER
FDA Form 3316a - Blue - DRUG MASTER FILE ARCHIVAL BINDER

PAPER BINDERS -

Front (flat size) - 267 x 292mm (10-1/2 x 11-1/2")
Back (flat size) - 267 x 305mm (10-1/2 x 12") (size includes 13mm (1/2") lip at top)

Binder MUST be of 11-point plate rope stock of extra heavy weight - Ink color MUST be BLACK - Maroon binder ink color MUST be WHITE -

Paper Binders include -

FDA Form 2626a - Red - NDA CHEMISTRY BINDER
FDA Form 2626b - Yellow - NDA PHARMACOLOGY BINDER
FDA Form 2626c - Orange - NDA PHARMACOKINETIC BINDER
FDA Form 2626d - White - NDA MICROBIOLOGY BINDER
FDA Form 2626e - Tan - NDA CLINICAL DATA BINDER
FDA Form 2626f - Green - NDA STATISTICS BINDER
FDA Form 2626h - Maroon - NDA FIELD SUBMISSION CHEMISTRY BINDER
FDA Form 2675a - Green - IND CHEMISTRY BINDER
FDA Form 2675b - Orange - IND MICROBIOLOGY BINDER

PRINTING - Required on front folder in a clear, sharp, permanent-type print in BLACK ink - Permanent adhesive labels may be used in a clear, sharp print - Printing must withstand a "Scotch Tape Test" which consists of pressing a strip of "Scotch" tape firmly on the printed area and removing - There should be NO transfer of the printed area on the tape -

BINDING - POLYETHYLENE binders (front and back) MUST contain an internal (HIDDEN) hinge formed in the material by heat and pressure - Hinge should extend along the entire left-hand binding edge of the binder and be of a depth to provide a clean straight fold free from wrinkle when created or folded on the hinge - Hinge holes should be reinforced with metal eyelets and suitable for accommodating an ACCO-type fastener allowing for expansion - Outside binder surfaces MUST be smooth with NO exposed hinges or fastener -

PAPER binders (front and back) MUST have 2 hinge holes scored along the entire left-hand binding edge and must be of a depth to provide a clean straight fold free from wrinkle when creased or folded on the score - Hinge holes should be reinforced and suitable for accommodating an ACCO-type fastener allowing for expansion -

Round corner the inside edge of tab on back folder and outside edges of the front and back folders on polyethylene and paper binders -

Finished margins MUST conform with binder sizes indicated above -

Below is a cover sample for FDA Form 2626, 2626a thru h - NDA Applications

Below is a cover sample for FDA Form 2675, 2675a and b - IND Appications

Below is a cover sample for FDA Form 3316, 3316a - Drug Master Files

SPECIFICATIONS Page 2

SAMPLE COVER - FORM FDA 2626 (series a-h)

NOTE: Sample is SMALLER in print (FONT) size than actual cover. Printing MUST match lay-out of previously submitted section binders.

VOLUME __________________

NEW DRUG APPLICATION

NDA No. _________

NAME OF APPLICANT

NAME OF NEW DRUG

SECTION NAME (* see below)

This submission: VOL.______OF______VOLS.

--------------------

Listed below are FDA New Drug Application (NDA) / Abbreviated New Drug Application (ANDA) binders identical to sample above. Section cover name is ONLY difference.

* FORM #	COLOR	INK	< strong="">SECTION COVER NAME
2626	Blue	Black	ARCHIVAL COPY
2626a	Red	Black	NDA CHEMISTRY
2626b	Yellow	Black	NDA PHARMACOLOGY
2626c	Orange	Black	NDA PHARMACOKINETIC
2626d	White	Black	NDA MICROBIOLOGY
2626e	Tan	Black	NDA CLINICAL DATA
2626f	Green	Black	NDA STATISTICS
2626h	Maroon	White	NDA FIELD SUBMISSION CHEMISTRY

SPECIFICATIONS Page 3

SAMPLE COVER - FORM FDA 2675 (series a-b)

Note: Sample is smaller in print (FONT) size than actual cover. Printing MUST match lay-out of previously submitted section binders.

VOLUME __________________

NOTICE OF CLAIMED

INVESTIGATIONAL

EXEMPTION FOR A

NEW DRUG

IND. NO.__________

SPONSOR

NAME OF DRUG (* see below)

This submission: VOL._____OF______VOLS.

--------------------

Listed below are FDA Investigational New Drug (IND) binders identical to sample above. Section cover name is ONLY difference.

* FORM #	COLOR	INK	COVER DRUG NAME
2675	Red	Black	IND NAME OF DRUG
2675a	Green	Black	IND NAME OF DRUG
2675b	Orange	Black	IND NAME OF DRUG

SPECIFICATIONS Page 4

SAMPLE COVER - FDA FORM 3316

NOTE: Sample is SMALLER in print (FONT) size than actual cover. Printing MUST match lay-out of previously submitted section binders.

VOLUME __________________

DRUG MASTER FILE

NO. ________

NAME OF APPLICANT

(* see below)

TYPE:

This submission: VOL.______OF______VOLS.

--------------------

Listed below are FDA Drug Master File (DMF) binders identical to sample above. File # and Type will be ONLY difference.

* FORM #	COLOR	INK	COVER NAME
3316	Red	Black	Drug Master File
3316a	Blue	Black	Drug Master File