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
Subjects shall be applicable to at least one of the following:
a) technical areas of current inspectional operations;
b) emerging investigational problems, actual or expected, confronting
Investigators;
c) new equipment with actual or potential use in regulated industries;
d) new inspectional equipment;
e) other technical areas of interest to the Districts.
2. Standards
a) Technical information must be accurate. If there are accepted variations
from stated information in certain circumstances, this must be acknowledged;
b) Texts must be concise, well organized, and well written;
c) Credit will be given to documents/authors when their material is
used; names under patent, trademark, or copyright protection will be so
designated;
d) Authors of drafts shall put their name, organization, and
phone number at the end.
3. Procedures
a) Before initiating articles, District personnel will discuss potential
topics with their supervisors to assure appropriate subject matter and
available time for writing the ITG.
b) 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.
c) After approval by the District, all draft ITG's shall be submitted
to: Inspection Branch, HFC-132
d) 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.
e) 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.*
f) *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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