9 CFR §114.9

1. (a)General requirements.
   1. (1)All copies of each Outline of Production or special outline or revised pages of either shall be prepared on heavy paper (8.5″ × 11″) of a type receptive to permanent stamp ink.
   2. (2)The name of the biological product (or component), the establishment license number, and the date prepared shall appear on a front cover page and each page of the Outline of Production or special outline. The name of the licensee (or foreign manufacturer) shall appear on the front cover page.
   3. (3)The pages shall be numbered in the upper center. At least 1 1/2 inch margin shall be left at the top of the first page and a 2 inch margin at the bottom of each page for the Animal and Plant Health Inspection Service stamp.
   4. (4)Amended pages shall be numbered the same as those being superseded. They shall bear the date prepared and refer to the date on the pages being superseded. If one replacement page supersedes more than one page, the new page shall indicate same, but if several replacement pages are added to supersede one page, the page number followed by letters shall be used.
   5. (5)The last page of both copies of either a new or a completely rewritten Outline of Production and each page revised separately shall be signed in the lower left corner by the authorized representative of the licensee (or foreign producer). Stamped or facsimile signatures are not acceptable.
   6. (6)A summary of changes shall appear on an attached page and refer to each page, paragraph, or subparagraph being changed.
   7. (7)Transmittal forms shall be used for the original and subsequent revisions. Transmittal forms are available on the Internet at (http://www.aphis.usda.gov/animal_health/vet_biologics/vb_forms.shtml).
2. (b)Special outline. An outline describing the preparation of a component of a biological product or an operation performed in the preparation of a biological product may be required if such special outline could be referred to in Outlines of Production to eliminate repetition. Each special outline shall be identified by number and shall not be used until accepted and filed by Animal and Plant Health Inspection Service.
3. (c)Outline of Production for anti-serum, antitoxin, and normal serum shall be written according to the following:
4. (d)Outline of Production for vaccines, bacterins, antigens, and toxoids shall be written according to the following:
5. (e)Outlines of Production for allergenic extracts shall be written according to the following:
6. (f)Outlines of Production for diagnostic test kits based on antigen-antibody reactions, and other diagnostics whose production methods are amenable to description as described herein shall be written according to the following requirements: