Contains Nonbinding Recommendations

Draft — Not for Implementation

March 2010

Table of Contents and Introduction (Part I)

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IV. Information Specific to Food or Color Additive Petition Submissions

Section IV of this document addresses FAP and CAP submissions (petition submissions).  You must submit an FAP in accordance with 21 CFR 171.1 and a CAP in accordance with 21 CFR 71.1.  We assign a number (FAP No. or CAP No., respectively) to your submission and review your submission to determine whether to establish a regulation for the use of a food additive or list a color additive in Title 21 of the Code of Federal Regulations. 

1. General Information about Petition Submissions
2. Petition Submissions in Electronic Format
3. Electronic Amendments and Updates to Petition Submissions
4. Food and Color Master Files

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A. General Information about Petition Submissions

1. How do the Parts on Form FDA 3503 relate to the elements of FAPs and CAPs?

   Table IV-1 shows the elements of FAPs and CAPs and links each element to the applicable part of Form FDA 3503. 

   Table IV-1
   Elements of FAPs and CAPs as Shown on Form FDA 3503

   Element of FAPs and CAPs	Applicable Part on Form FDA 3503
   Introductory information about the submission	I
   Information about the petitioner (and any attorney or agent acting on behalf of the petitioner)	II
   General administrative information	III
   Information specific to Food Additive Petitions	IV.A
   Information (including fees) specific to Color Additive Petitions	IV.B
   Identity	V
   Administrative	VI
   Administrative Technical	VI
   Chemistry	VI
   Safety	VI
   Environmental	VI
   Signature	VII
   N/A	VIII (List of Attachments)

2. How should I organize a new petition submission?

   You should organize a new petition submission as a series of documents presenting the elements of a petition in an order corresponding to that of the elements listed on Form FDA 3503.  A summary of these elements is listed in Table IV-1 of this document and described in the instructions for Form FDA 3503 (see Appendix 1.  If you include any data or information not identified as an element on Form FDA 3503, you should place these data or information in a logical place in your submission based on the type of information.

3. Am I required to include a proposed regulation with my petition submission?

   You must include a proposed regulation if your petition would alter an existing food additive regulation or color additive listing (see 21 CFR 171.1(c)G and 21 CFR 71.1(c)H).  If your petition is for a new food additive regulation or color additive listing, you may include a proposed regulation (see 21 CFR 171.1(c)F and 21 CFR 71.1(c)F).

4. Am I required to include a proposed tolerance with my petition submission?

   You must include a proposed tolerance with your petition if a tolerance is required to ensure safety (see 21 CFR 171.1(c)F and 21 CFR 71.1(c)F).   

B. Petition Submissions in Electronic Format

General Questions and Answers about Petition Submissions in Electronic Format

5. How should I organize an electronic FAP or CAP submission?

   You should organize an electronic FAP or CAP submission using the foldering structure available in a downloadable Petition Submission Roadmap (see instructions in Appendix 1 and the roadmap in Appendix 15).   The entire Petition Submission Roadmap is organized under the folder entitled “Main directory.”  The “Main directory” includes six first-level folders, and several of these first-level folders include second-level and third-level subfolders.  We show these folders and subfolders, using an outline format, in Figure IV-1, below.

   Figure IV-1

   Outline Representing the Folders and Subfolders in a Petition Submission Roadmap (“Main directory”)

   • Main directory
     • Administrative
       • Designation of Nondisclosable Information
       • Redacted Document
       • Incoming Correspondence
         • Amendment
         • Update
     • Administrative Technical
     • Chemistry
       • Studies
       • Stability
       • Technical Effect
       • Migration
       • Other
         • Methods
         • References
     • Safety
       • Studies
         • Genetic Toxicity Studies
         • Short Term Toxicity Studies Rodents
         • Short Term Toxicity Studies Non-Rodents
         • Subchronic Toxicity Studies Rodents
         • Subchronic Toxicity Studies Non-Rodents
         • One Year Toxicity Studies Non-Rodents
         • Chronic Toxicity or Combined Chronic Toxicity/Carcinogenicity Studies Rodents
         • Carcinogenicity Studies Rodents
         • Reproduction Studies
         • Developmental Toxicity Studies
         • Immunotoxicity Studies
         • Metabolism and Pharmacokinetic Studies
         • Neurotoxicity Studies
         • Ocular Studies
         • Dermal Studies
         • Human Studies
         • Other Studies
       • References
         • Literature Publications
         • Other
     • Environmental
       • Confidential Environmental Information
       • Studies
       • References
     • Other
6. When should I use the specific folders and subfolders in the Petition Submission Roadmap (“Main directory”)?

   You should use the specific folders and subfolders as shown in Table IV-2. You should not place any specific files directly in “Main directory,” which refers to the entire submission organized in the foldering structure (refer to Figure III-1 and Figure IV-1). “Main directory” only contains folders. 

   Table IV-2
   When to Use Specific Folders and Subfolders in the “Main Directory” of a Petition Submission Roadmap*

   Folder/Subfolder	When to Use it
   Administrative folder	Any time you transmit a new submission, a file relating to fees associated with a CAP, or a redacted electronic file(s)
   Designation of Nondisclosable Information folder	Any time you transmit data or information that satisfies the criteria for exemption from disclosure
   Redacted Folder	Any time you submit a redacted copy, place it in the redacted subfolder under the Administrative folder, regardless of whether you are transmitting a new submission, an amendment, or an update
   Incoming Correspondence folder	You should not place any specific files directly in the Incoming Correspondence folder. The Incoming Correspondence folder only contains subfolders
   Incoming Correspondence/Submission Form Subfolder	Any time you transmit an amendment or update to your petition
   Incoming Correspondence/ Amendment Subfolder	Only when the data or information you transmit to a filed submission in response to correspondence from us do not fall within the scope of any other folder, such as Chemistry, Safety, or Environmental
   Incoming Correspondence/ Update Subfolder	Only when the data or information you transmit to a filed submission on your own initiative (i.e., not in response to correspondence from us) do not fall within the scope of any other folder, such as Chemistry, Safety, or Environmental
   Administrative Technical Folder	Any time you transmit a proposed regulation, proposed tolerance, or information regarding exemption from batch certification for a color additive, regardless of whether you are transmitting a new submission, an amendment, or an update
   Chemistry Folder and Applicable Subfolders	Any time you transmit chemistry data or information, regardless of whether you are transmitting a new submission, an amendment, or an update
   Safety Folder and Applicable Subfolders	Any time you transmit safety data or information, regardless of whether you are transmitting a new submission, an amendment, or an update
   Environmental Folder and Applicable Subfolders	Any time you transmit environmental data or information, regardless of whether you are transmitting a new submission, an amendment, or an update
   Other Folder	Any time you transmit data or information in an original submission that does not fall within the scope of any other folders or subfolders

   *If you are transmitting an amendment or update to your submission, you should rename “Main directory” to reflect the submission designation we assigned to it (i.e., FAP9A9999 or CAP 9C9999).

7. How should I name files in an electronic petition submission?

   You should name each file using both generic and specific elements as described in Section III.C and Appendix 12 of this document.  Generic elements in the file names specific to petition submissions are included in the examples in Tables IV-3 through IV-11 (below).

   Questions and Answers about Files in the Administrative and Administrative Technical Folders in the original Petition Submissions

8. What subfolders and files should I place in the “Administrative” folder?

   Table IV-3 shows the subfolders and files you should place in the “Administrative” folder.

   Table IV-3
   Subfolders and Files in the “Administrative” Folder of a Petition

   Folder/subfolder	File Name	Information in File	Applicable Regulatory Citation
   Administrative	Form3503_..._YYYY-MM-DD.pdf	Some specific information in the submission and a list of documents included	N/A
   Administrative	CoverLetter_..._YYYY-MM-DD.pdf	Letter accompanying the submission if you choose to send a letter in addition to Form FDA 3503	21 CFR 71.1 21 CFR 171.1
   Administrative/ Designation of Confidential Information	DesignationOfConfidential Information_ ..._YYYY-MM-DD.pdf	A description of the data or information in your submission that you designated as nondisclosable information.	21 CFR 20.61(d)
   Administrative/ Redacted	RedactedBySubmitter_…_YYYY-MM-DD.pdf	Data or information copied from one or more files in your submission and then modified by deletion of data or information you designated as nondisclosable information.	N/A*

   *N/A means “Not applicable.”

9. What files should I place in the “Administrative Technical” subfolder?

   Table IV-4 shows the files you should place in the “Administrative Technical” folder.

   Table IV-4
   Files in the “Administrative Technical” Folder of a Petition Submission

   File Name	Information in File	Applicable Regulatory Citation
   ProposedRegulation_…_YYYY-MM-DD.pdf	Your proposed text for the food additive regulation or color additive listing.	21 CFR 71.1(c) H 21 CFR 171.1(c) G
   ProposedTolerance_…_YYYY-MM-DD.pdf	Your proposed text for the tolerance provision of the food additive regulation or color additive listing, if a tolerance is required to ensure safety.	21 CFR 71.1(c) F 21 CFR 171.1(c) F
   ExemptCertification_…_YYYY-MM-DD.pdf (CAP only)	The reasons why batch certification for a color additive is not necessary, including supporting data to establish the safety of the intended use (when applicable)	21 CFR 71.1(c) G

   Questions and Answers about Files in the Chemistry, Safety and Environmental Folders of a Petition Submission

10. What files should I place directly in the “Chemistry” folder (rather than under any “Chemistry” subfolders)?

    Table IV-5 shows the files you should place directly in the “Chemistry” folder.

    Table IV-5
    Files in the “Chemistry” Folder of a Petition Submission

    File Name	Information in File	Applicable Regulatory Citation or Guidance
    Identity_..._YYYY-MM-DD.pdf	The physical, chemical, and biological properties of the additive, as well as any information about the chemical identity and composition of the additive not included on Form FDA 3503	21 CFR 71.1(c) A 21 CFR 171.1(c) A
    UseAndTechnicalEffect_..._ YYYY-MM-DD.pdf	Information about the foods in which the additive will be used, the levels of use in such foods, and the purpose for which the additive will be used, and all directions, recommendations, and suggestions regarding the proposed use	21 CFR 71.1(c) B 21 CFR 171.1(c) B 21 CFR 170.3(n) 21 CFR 170.3(o)
    Labeling_..._ YYYY-MM-DD.pdf	CAP: Specimens of the labeling proposed for the additive FAP: Specimens of the labeling proposed for the additive and any labeling that will be required by applicable provisions of the Act on the finished food by reason of the use of the additive	21 CFR 71.1(c) B 21 CFR 171.1(c) B
    ManufacturingMethod_..._ YYYY-MM-DD.pdf	Information about the manufacturing process and any person other than the petitioner who performs any manufacturing, processing, and packing operations for the additive	21 CFR 71.1(c) A 21 CFR 171.1(c) A 21 CFR 171.1(j)
    Residues_..._ YYYY-MM-DD.pdf	How residues of the additive may occur in food when the additive would be used in packaging and what residues may reasonably be anticipated	21 CFR 71.1(c) B 21 CFR 171.1(c) B
    Specifications_..._ YYYY-MM-DD.pdf	CAP: Specifications prescribing the additive’s component(s) and identifying and limiting the reaction byproducts and other impurities. FAP: Specifications prescribing the minimum content of the desired component(s) and identifying and limiting the reaction byproducts and other impurities. Where such information is not available, you should include a statement as to the reasons why.	21 CFR 71.1(c) A 21 CFR 171.1(c) A Ref. 7 Ref. 8
    ExposureEstimates_..._ YYYY-MM-DD.pdf	The basis for any alternative approach, other than the approach described in Refs. 7 and 9), that a petitioner wishes OFAS to use in estimating daily intake. CAP: Complete data to allow us to consider the probable consumption of, and/or other relevant exposure from the additive and of any substance formed in or on food, drugs, or cosmetics because of such additive; and the cumulative effect, if any, of such additive in the diet of man or animals.	21 CFR 71.1(c) E Ref. 7 Ref. 9

11. What files should I place in the “Chemistry Studies” subfolders?

    Table IV-6 shows the subfolders and files you should place in the “Studies” subfolder of the “Chemistry” folder.

    Table IV-6
    Subfolders and Files in the “Studies” Subfolder of the “Chemistry” Folder of a Petition

    Folder/ Subfolder	File Name	Information in the File	Applicable Regulatory Citation or Guidance
    Chemistry/ Studies/ Stability	StabilityData_..._ YYYY-MM-DD.pdf	Stability data and, when needed, the expiration period. A CAP also must include any packaging and labeling precautions needed to preserve stability.	21 CFR 71.1(c) A 21 CFR 171.1(c) A Ref. 7 Ref. 8
    Chemistry/ Studies/ Intended Effect	IntendedEffect_..._ YYYY-MM-DD.pdf	FAP Only: Data establishing that the food additive will have the intended physical or other technical effect or that it may reasonably be expected to become a component, or to affect the characteristics, directly or indirectly, of food and the amount necessary to accomplish this. These data should include information in sufficient detail to permit evaluation with control data.	21 CFR 171.1(c) C Ref. 7
    Chemistry/ Studies/ Migration	MigrationData_..._ YYYY-MM-DD.pdf	Information sufficient to permit estimation of consumer exposure to a food additive.	21 CFR 171.1(c) B Ref. 7
    Chemistry/ Studies/ Other	[Sweetness Potency ]_..._ YYYY-MM-DD.pdf	Study of Sweetness Potency	N/A

12. What files should I place in the Chemistry “Methods” and “References” subfolders?

    Table IV-7 shows the files you should place in the Chemistry “Methods” and “References” subfolders.

    Table IV-7
    Files in the Chemistry “Methods” and “References” Subfolders of a Petition Submission

    Folder/ Subfolder	File Name	Information in the File	Applicable Regulatory Citation or Guidance
    Chemistry/ Methods	AnalyticalMethod_..._ YYYY-MM-DD.pdf	FAP and CAP: A description of practicable methods to determine the amount of the additive in the raw, processed, and/or finished food and of any substance formed in or on such food because of its use. CAP: A description of practicable methods to determine the pure color and all intermediates, subsidiary colors, and other components of the color additive.	21 CFR 71.1(c) C 21 CFR 171.1(c) D Ref. 7 Ref. 8
    Chemistry/ References	See Appendix 12	Any references to the scientific literature	Ref. 7 Ref. 8 Ref. 10 Ref. 2

13. What files should I place directly in the “Safety” folder (rather than under any “Safety” subfolders)?

    Table IV-8 shows the files you should place in the “Safety” folder.

    Table IV-8
    Files in the “Safety” Folder of a Petition Submission

    File Name	Information in File	Applicable Regulatory Citation or Guidance
    ToxicologyNarrative_..._ YYYY-MM-DD.pdf	A summary of the results of, and conclusions from, safety studies included in your petition submission and relevant safety studies in the scientific literature.	Ref. 2

14. What files should I place in the “Safety Studies” subfolders?

    Table IV-9 shows examples of the files you should place in the “Studies” subfolders.

    Table IV-9
    Folders and Files in the “Studies” Subfolder of the “Safety” Folder of a Petition Submission

    Subfolder	Examples of File Names	Applicable Regulatory Citation or Guidance
    Safety/Studies/ GeneticToxicityStudies	Ames_..._YYYY-MM-DD.pdf	21 CFR 71.1(c) D 21 CFR 171.1(c) E Ref. 15 Ref. 16
    Safety/Studies/ ShortTermToxicity StudiesRodents	ShortTermToxicity_..._YYYY-MM-DD.pdf	21 CFR 71.1(c) D 21 CFR 171.1(c) E Ref. Ref. 15 Ref. 16
    Safety/Studies/ ShortTermToxicity StudiesNon-Rodents	ShortTermToxicity_..._YYYY-MM-DD.pdf	21 CFR 71.1(c) D 21 CFR 171.1(c) E Ref. Ref. 15 Ref. 16
    Safety/Studies/ SubchronicToxicity StudiesRodents	SubchronicToxicity_..._YYYY-MM-DD.pdf	21 CFR 71.1(c) D 21 CFR 171.1(c) E Ref. Ref. 15 Ref. 16
    Safety/Studies/ SubchronicToxicity StudiesNon-Rodents	SubchronicToxicity_..._YYYY-MM-DD.pdf	21 CFR 71.1(c) D 21 CFR 171.1(c) E Ref. Ref. 15 Ref. 16
    Safety/Studies/ OneYearToxicity StudiesNon-Rodents	ChronicToxicity_..._YYYY-MM-DD.pdf	21 CFR 71.1(c) D 21 CFR 171.1(c) E Ref. Ref. 15 Ref. 16
    Safety/Studies/ ChronicToxicityOr CombinedChronic Toxicity/Carcinogenicity StudiesRodents	ChronicToxicity_..._YYYY-MM-DD.pdf	21 CFR 71.1(c) D 21 CFR 171.1(c) E Ref. Ref. 15 Ref. 16
    Safety/Studies/ CarcinogenicityStudies Rodents	Carcinogenicity_..._YYYY-MM-DD.pdf	21 CFR 71.1(c) D 21 CFR 171.1(c) E Ref. Ref. 15 Ref. 16
    Safety/Studies/ ReproductionStudies	ReproductiveToxicity_..._YYYY-MM-DD.pdf	21 CFR 71.1(c) D 21 CFR 171.1(c) E Ref. Ref. 15 Ref. 16
    Safety/Studies/ DevelopmentalToxicity Studies	ReproductiveToxicityTeratology_..._YYYY-MM-DD.pdf	21 CFR 71.1(c) D 21 CFR 171.1(c) E Ref. Ref. 15 Ref. 16
    Safety/Studies/ ImmunotoxicityStudies	Immunotoxicity_..._YYYY-MM-DD.pdf	21 CFR 71.1(c) D 21 CFR 171.1(c) E Ref. Ref. 15 Ref. 16
    Safety/Studies/ MetabolismAnd PharmacokineticStudies	PharmacokineticRats_..._YYYY-MM-DD.pdf	21 CFR 71.1(c) D 21 CFR 171.1(c) E Ref. Ref. 15 Ref. 16
    Safety/Studies/ NeurotoxicityStudies	Neurotoxicity_..._MMMM-MM-DD.pdf	21 CFR 71.1(c) D 21 CFR 171.1(c) E Ref. Ref. 15 Ref. 16
    Safety/Studies/ HumanClinicalStudies	HumanClinical_..._ YYYY-MM-DD.pdf	21 CFR 71.1(c) D 21 CFR 171.1(c) E Ref. Ref. 15 Ref. 16
    Safety/Studies/ EpidemiologyStudies	Epidemiology_..._YYYY-MM-DD.pdf	Ref. Ref. 15 Ref. 16
    Safety/Studies/ OcularStudies	OcularIrritation_..._YYYY-MM-DD.pdf	Ref. 17
    Safety/Studies/ DermalStudies	Dermal_..._YYYY-MM-DD.pdf	Ref. 17
    Safety/Studies/ OtherStudies	[DescriptiveName]_..._YYYY-MM-DD.pdf	21 CFR 71.1(c) D 21 CFR 171.1(c) E

15. What files should I place in the “Environmental” folder of a petition?

    Table IV-10 shows the files you should place in the “Environmental” folder.

    Table V-10
    Folders and Files in the “Environmental” Folder of a Petition Submission Roadmap

    Folder/ Subfolder	File Name	Information in the File	Applicable Regulatory Citation or Guidance
    Environmental	EA_ …_YYYY-MM-DD.pdf	Concise public document that provides sufficient evidence and analysis for FDA to determine whether to prepare an Environmental Impact Statement (EIS) or a Finding of No Significant Impact (FONSI)	21 CFR 71.1(c) J 21 CFR 171.1(c) H 21 CFR 25.40 Ref. 19
    Environmental	ClaimCategorical Exclusion_..._YYYY-MM-DD.pdf	(1) The section of the CFR under which the categorical exclusion is claimed; (2) A statement of compliance with the categorical exclusion criteria; and (3) A statement that, to the submitter's knowledge, no extraordinary circumstances exist that require submission of an Environmental Assessment.	21 CFR 71.1(c) J 21 CFR 171.1(c) H 21 CFR 25.15 21 CFR 25.30 21 CFR 25.32 Ref. 19
    Environmental/ Confidential Environmental Information	MarketVolume_ …_YYYY-MM-DD.pdf	Data and information that are protected from disclosure under 18 U.S.C. 1905, 21 U.S.C. 331(j) or 360j(c)	21 CFR 25.51 Ref. 19
    Environmental/Studies	…_YYYY-MM-DD.pdf	Study reports of environmental fates or effects studies	Ref. 19
    Environmental/References	…_YYYY-MM-DD.pdf	Environmental literature references (published studies, excerpts)	Ref. 19

 C. Electronic Amendments and Updates to Petition Submissions

16. What recommendations apply to amendments and updates to petition submissions?

    You should refer to Section III.F of this document for general recommendations applying to amendments and updates in electronic format. 

    When transmitting any amendment or update to a petition submission, you should organize your submission into individual files addressed to specific topic areas (administrative, chemistry, safety, or environmental), even if an amendment responds to multiple questions we sent you in a single letter.  You then should place these files in appropriate folders/subfolders according to the Petition Submission Roadmap. 

    For example, an amendment to a FAP could include two Chemistry files (one to revise specifications and another to revise an analytical method), a Safety file responding to our questions about a subchronic toxicity study conducted in dogs, and a file containing a revised Environmental Assessment.  In this example, you would:

    • Place the file containing revised specifications directly in the “Chemistry” folder;
    • Place the file containing the revised analytical method in the Chemistry/Methods subfolder;
    • Place the file containing the response to our questions about the toxicology study in the Safety/Studies/Subchronic Toxicity Non-Rodents subfolder; and
    • Place the revised Environmental Assessment in the Environmental Assessment folder.
17. What files should I place in the “Incoming Correspondence” subfolder?

    Table IV-11 shows the files you should place in the two subfolders of the “Incoming Correspondence” folder.

    Table IV-11
    Files in the “Additional Information/Incoming Correspondence” Subfolder for a Petition Submission

    Subfolder	File Name	Information in the File
    IncomingCorrespondence/ Amendment	YYYY-MM-DD_ Form3503_….pdf	Form with responsive material completed for an amendment.
    IncomingCorrespondence/ Amendment	YYYY-MM-DD_Amendment_…pdf	An amendment that does not fit in any of the other folders (e.g. Chemistry, Safety, Environmental,etc)
    IncomingCorrespondence/ Update	YYYY-MM-DD_ Form3503_….pdf	Form with responsive material completed for an update.
    IncomingCorrespondence/ Update	YYYY-MM-DD_Update_…pdf	An update that does not fit in any of the other folders (e.g. Chemistry, Safety, Environmental, etc)

18. Where can I find an example of a foldering structure with an amendment for a FAP?

    Below is an example of an amendment to an existing, fictional FAP (FAP 0A9999), arranged in the standard roadmap.  Folder names are in bold and file names are in italics; for clarity, we omitted empty folders.  In this example, the amendment responds to an FDA letter dated 11-20-2006, which requested further information.  Note that each file name begins with the date the amendment is submitted (see Section III.C and Appendix 12 of this document for file naming conventions).  We would place these amendment documents in the corresponding folders in our database file for FAP 0A9999, alongside documents previously submitted.  (You should not re-submit any previously submitted documents.)

    • FAP 0A9999 
      • Administrative
        • Incoming Correspondence
          • Amendment
            • 2006-12-07_Form FDA 3503_InResponseToFDA2006-11-20 Letter.pdf
      • Chemistry
        • Methods
          • 2006-12-07_ResponsesToFDA2006-11-20ChemistryQuestions_(AnalyticalMethod_ …).pdf
      • Safety
        • Studies
          • SubchronicToxicityStudies
            • 2006-12-07_SubchronicToxicity_Study5567_ EmulsifierX_Rats_OralGavage_ 2000-11-08.pdf          
      • Environmental
        • 2006-12-07_EA_Revised_EmulsifierX.pdf

D. Food and Color Master Files

19. How do the parts on Form FDA 3503 relate to the elements of FMFs and CMFs?

    Table IV-12 shows the elements of FMFs and CMFs and links each element to the applicable part of Form FDA 3503. 

    Table IV-12
    Elements of FMFs and CMFs as Shown on Form FDA 3503

    Element of FMFs and CMFs	Applicable Part on Form FDA 3503
    Introductory information about the submission	I
    Information about the company responsible for the master file (and any attorney or agent acting on behalf of that company)	II
    General administrative information	III
    Information specific to Food or Color Master Files	IV.C
    Identity	V
    Administrative Technical (when a submission is in advance of a planned FAP or CAP)	VI
    Chemistry	VI
    Safety	VI
    Environmental	VI
    Signature	VII
    N/A	VIII (List of Attachments)

20. How should I organize an electronic master file submission prepared according to the elements on Form FDA 3503?

    You should organize an electronic master file submission prepared according to the elements on Form FDA 3503 using the foldering structure available in a downloadable Petition Roadmap (see instructions in Appendix 1 and the roadmap in Appendix 15).  In general, you should follow the recommendations in Sections III and IV.B of this document for more detailed information about organizing an electronic master file submission according to the elements of Form FDA 3503.