21 C.F.R. · Food and Drugs
21 C.F.R. § 71.2

Notice of filing of petition.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 71.2 — Notice of filing of petition.

§ 71.2 Notice of filing of petition. (a) Except where the petition involves a new drug, the Commissioner, within 15 days after receipt, will notify the petitioner of acceptance or nonacceptance of a petition, and if not accepted the reasons therefor. If accepted, the date of the notification letter sent to petitioner becomes the date of filing for the purposes of section 721(d)(1) of the act. If the petitioner desires, he may supplement a deficient petition after being notified regarding deficiencies. If the supplementary material or explanation of the petition is deemed acceptable, petitioner shall be notified. The date of such notification becomes the date of filing. If the petitioner does not wish to supplement or explain the petition and requests in writing that it be filed as submitted, the petition shall be filed and the petitioner so notified. The date of such notification becomes the date of filing. Where the petition involves a new drug, notification to the petitioner will be made in accordance with § 70.10(b)(3) of this chapter. (b) The Commissioner will cause to be published in the Federal Register within 30 days from the date of filing of such petition a notice of the filing, the name of the petitioner, and a brief description of the proposal in general terms. A copy of the notice will be mailed to the petitioner when the original document is signed. [42 FR 15639, Mar. 22, 1977, as amended at 64 FR 400, Jan. 5, 1999]

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
Root-LD Entity Data
◈ Machine-Readable Provenance Record Root-LD v1.0 · boisestandard.org
Federation ID
BS-CFR21-SEC-1B84D8
Entity Class
REGULATION / FEDERAL-CFR-SECTION
Domain Signature
boisestandard.org
Citation
21 C.F.R. § 71.2
Corpus
CFR — Code of Federal Regulations
Status
✓ ACTIVE
Source
PRIMARY-SOURCE
Source Verified
✓ TRUE
Content Hash
795cf0c6adebe0d8...
Semantic Edges
Pending — corpus passes queued
The regulatory text of 21 C.F.R. § 71.2 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
Navigate Corpus — Title 21 C.F.R.
◈ Provenance
boisestandard.org United States Law CFR Title 21 21 C.F.R. § 71.2