§ 25.31. Human drugs and biologics.
299 words·~1 min read·
/us/cfr/t21/s§ 25.31·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:
(a)Action on an NDA, abbreviated application, application for marketing approval of a biologic product, or a supplement to such applications, or action on an OTC monograph, if the action does not increase the use of the active moiety.
(b)Action on an NDA, abbreviated application, or a supplement to such applications, or action on an OTC monograph, if the action increases the use of the active moiety, but the estimated concentration of the substance at the point of entry into the aquatic environment will be below 1 part per billion.
(c)Action on an NDA, abbreviated application, application for marketing approval of a biologic product, or a supplement to such applications, or action on an OTC monograph, for substances that occur naturally in the environment when the action does not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment.
(d)Withdrawal of approval of an NDA or an abbreviated application.
(e)Action on an IND.
(f)Testing and release by the Food and Drug Administration of lots or batches of a licensed biologic product.
(g)Establishment of bioequivalence requirements for a human drug or a comparability determination for a biologic product subject to licensing.
(h)Issuance, revocation, or amendment of a standard for a biologic product.
(i)Revocation of a license for a biologic product.
(j)Action on an application for marketing approval for marketing of a biologic product for transfusable human blood or blood components and plasma. [62 FR 40592, July 29, 1997, as amended at 63 FR 26697, May 13, 1998; 64 FR 399, Jan. 5, 1999; 70 FR 14980, Mar. 24, 2005]
Connections113 cite this
Cited by 113 sections · top 60
register
- Rules and RegulationsDirect final rule
- NoticesNotice of eligibility; request for data and information
- NoticesProposed rule
- Rules and RegulationsFinal rule
- Proposed RulesProposed rule
- Rules and RegulationsFinal rule
- Rules and RegulationsFinal rule; technical amendment
- Rules and RegulationsFinal rule; technical amendment
- Rules and RegulationsFinal rule; technical amendment
- NoticesRequest for data and information
- NoticesProposed rule
- NoticesProposed rule
- Rules and RegulationsDirect final rule
- Rules and RegulationsFinal rule
- Rules and RegulationsFinal rule
- Proposed RulesProposed rule; supplemental notice of proposed rulemaking
- UnknownFinal rule; technical amendment
- Proposed RulesFinal rule
- NoticesFinal rule; delay of implementation date of certain provisions
- Proposed RulesProposed rule
- Proposed RulesProposed rule
- NoticesNotice of public hearing; request for comments
- Rules and RegulationsFinal rule
- Rules and RegulationsFinal rule; partial delay of compliance dates
- NoticesProposed rule
- Rules and RegulationsFinal rule
- NoticesFinal rule
- Rules and RegulationsFinal rule
- Rules and RegulationsFinal rule
- Rules and RegulationsFinal rule
- Rules and RegulationsFinal rule
- Rules and RegulationsCorrecting amendments
- Rules and RegulationsProposed rule
- Rules and RegulationsFinal rule
- Rules and RegulationsNotice of proposed rulemaking
- Proposed RulesProposed rule
- Rules and RegulationsFinal rule; technical amendment
- Proposed RulesProposed rule
- UnknownFinal rule
- Rules and RegulationsAdvance notice of proposed rulemaking
- Rules and RegulationsFinal rule
- Rules and RegulationsFinal rule
- UnknownInterim rule and request for comments
- Rules and RegulationsProposed rule
- NoticesNotice of availability; request for comment
- Proposed RulesProposed rule
- Rules and RegulationsDirect final rule
- NoticesFinal rule
- Rules and RegulationsFinal rule
- Rules and RegulationsFinal rule; partial stay; reopening of the administrative record
- Rules and RegulationsFinal rule
- Proposed RulesProposed rule
- Rules and RegulationsFinal rule
- Rules and RegulationsNotice
- Rules and RegulationsProposed rule
- Rules and RegulationsFinal rule
- Rules and RegulationsFinal rule; finding of ineligibility for inclusion in final monograph
- Rules and RegulationsFinal rule
- NoticesFinal rule; lift of partial stay of effective date
Citation graph
cites case law
§ 25.31
Human drugs and biologics.
Fed. Reg.×112
C.F.R.×1
Cites 0Cited by 113 across 2 sources