Inspections, Compliance, Enforcement, and Criminal Investigations

Field Submission of Articles

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DEPT. OF HEALTH, EDUCATION, AND
WELFARE PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
*ORA/ORO/DEIO/IB*
Date: 8/15/84 Number: #13
Revised
Related Program Areas:
All Programs

ITG SUBJECT: FIELD SUBMISSION OF INSPECTION TECHNICAL GUIDE (ITG)

Since the first issuance in February 1972, ITG's covering a variety of subjects have been published to provide investigators with information not previously available to the Districts. Although most of the ITG's have been written by headquarters staff, we recognize that there are District personnel who have technical information which would be valuable to others in the field. Therefore, we are inviting District personnel to submit suitable articles.

Submitted ITG articles should emphasize facets of technical areas that are not generally known. The fact that some experienced or specialized FDA personnel may already have such knowledge or information will not preclude publication if a significant number of FDA personnel would benefit. The following guide is provided to help in preparing ITG submissions.

  1. Content
  2. Subjects shall be applicable to at least one of the following:

    1. technical areas of current inspectional operations;
    2. emerging investigational problems, actual or expected, confronting Investigators;
    3. new equipment with actual or potential use in regulated industries;
    4. new inspectional equipment;
    5. other technical areas of interest to the Districts.
  3. Standards
    1. Technical information must be accurate. If there are accepted variations from stated information in certain circumstances, this must be acknowledged;
    2. Texts must be concise, well organized, and well written;
    3. Credit will be given to documents/authors when their material is used; names under patent, trademark, or copyright protection will be so designated;
    4. Authors of drafts shall put their name, organization, and phone number at the end.
  4. Procedures
    1. Before initiating articles, District personnel will discuss potential topics with their supervisors to assure appropriate subject matter and available time for writing the ITG.
    2. After supervisory concurrence, District personnel shall call the Director of Inspection Branch (301) 443-3340 to explain briefly the proposed topic and obtain assurance nobody else is developing the same topic.
    3. After approval by the District, all draft ITG's shall be submitted to: Inspection Branch, HFC-132
    4. Each issue will be routed for review and comment to the Division of *Emergency and Investigational Operations (DEIO)*, Office of Regional Operations; each Center having a responsibility in the subject area; and other units or individuals having a special interest in the subject.
    5. Comments will be acted upon by the Director, *DEIO, or a designated person. It will be decided whether or not changes are required. If changes are required, the ITG author will be notified, and if necessary, the ITG draft will be returned to the District for corrections or changes.*
    6. *DEIO will handle printing and distribution of the final document.*

*Any suggestions concerning ITG improvements and subjects are welcome. If further information is required, call *the Inspection Branch Director on (301) 443-3340.*

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