[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR10.70]

[Page 107]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents
 
              Subpart B--General Administrative Procedures
 
Sec. 10.70  Documentation of significant decisions in administrative file.

    (a) This section applies to every significant FDA decision on any 
matter under the laws administered by the Commissioner, whether it is 
raised formally, for example, by a petition or informally, for example, 
by correspondence.
    (b) FDA employees responsible for handling a matter are responsible 
for insuring the completeness of the administrative file relating to it. 
The file must contain:
    (1) Appropriate documentation of the basis for the decision, 
including relevant evaluations, reviews, memoranda, letters, opinions of 
consultants, minutes of meetings, and other pertinent written documents; 
and
    (2) The recommendations and decisions of individual employees, 
including supervisory personnel, responsible for handling the matter.
    (i) The recommendations and decisions are to reveal significant 
controversies or differences of opinion and their resolution.
    (ii) An agency employee working on a matter and, consistent with the 
prompt completion of other assignments, an agency employee who has 
worked on a matter may record individual views on that matter in a 
written memorandum, which is to be placed in the file.
    (c) A written document placed in an administrative file must:
    (1) Relate to the factual, scientific, legal or related issues under 
consideration;
    (2) Be dated and signed by the author;
    (3) Be directed to the file, to appropriate supervisory personnel, 
and to other appropriate employees, and show all persons to whom copies 
were sent;
    (4) Avoid defamatory language, intemperate remarks, undocumented 
charges, or irrelevant matters (e.g., personnel complaints);
    (5) If it records the views, analyses, recommendations, or decisions 
of an agency employee in addition to the author, be given to the other 
employees; and
    (6) Once completed (i.e., typed in final form, dated, and signed) 
not be altered or removed. Later additions to or revisions of the 
document must be made in a new document.
    (d) Memoranda or other documents that are prepared by agency 
employees and are not in the administrative file have no status or 
effect.
    (e) FDA employees working on a matter have access to the 
administrative file on that matter, as appropriate for the conduct of 
their work. FDA employees who have worked on a matter have access to the 
administrative file on that matter so long as attention to their 
assignments is not impeded. Reasonable restrictions may be placed upon 
access to assure proper cataloging and storage of documents, the 
availability of the file to others, and the completeness of the file for 
review.