§10.115. Good guidance practices. — Inbound Citations

(v) Material placed on public display under the regulations in this chapter, e.g., agency guidance documents developed under § 10.115.

(c) In addition to the guidance documents subject to § 10.115, 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 21 U.S.C. 360ii. These recommendations may, in the discretion of the Commissioner, be handled under the procedures established in § 10.115, except that the recommendations will be included in a separate public file of recommendations established by the Dockets Management Staff and will be separated from the guidance documents 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.

(a) FDA has made available guidance documents under § 10.115 of this chapter to help you to comply with certain requirements of this part.

(a) FDA has made available guidance documents under § 10.115 of this chapter to help you to comply with certain requirements of this part.

(a) FDA has made available guidance documents under § 10.115 of this chapter to help you comply with certain requirements of this part.