[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR10.90]

[Page 110]
 
                        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. 10.90  Food and Drug Administration regulations, recommendations, and agreements.

    (a) Regulations. FDA regulations are promulgated in the Federal 
Register under Sec. 10.40 or Sec. 10.50 and codified in the Code of 
Federal Regulations. Regulations may contain provisions that will be 
enforced as legal requirements, or which are intended only as guidelines 
and recommendations, or both. The dissemination of draft notices and 
regulations is subject to Sec. 10.80.
    (b) [Reserved]
    (c) Recommendations. In addition to the guidelines subject to 
paragraph (b) of this section, FDA often formulates and disseminates 
recommendations about matters which are authorized by, but do not 
involve direct regulatory action under, the laws administered by the 
Commissioner, e.g., model State and local ordinances, or personnel 
practices for reducing radiation exposure, issued under 42 U.S.C. 243 
and 263d(b). These recommendations may, in the discretion of the 
Commissioner, be handled under the procedures established in paragraph 
(b) of this section, except that the recommendations will be included in 
a separate public file of recommendations established by the Dockets 
Management Branch and will be separated from the guidelines in the 
notice of availability published in the Federal Register, or be 
published in the Federal Register as regulations under paragraph (a) of 
this section.
    (d) Agreements. Formal agreements, memoranda of understanding, or 
other similar written documents executed by FDA and another person will 
be included in the public file on agreements established by the Freedom 
of Information Staff (HFI-35) under Sec. 20.108. A document not included 
in the public file is deemed to be rescinded and has no force or effect 
whatever.

[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 65 
FR 56477, Sept. 19, 2000]