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- 21 CFR 510.202 · Definitions.
- 21 CFR 510.203 · Initiation of a proceeding to establish or amend an import tolerance.
- 21 CFR 510.205 · Content and administration of a request.
- 21 CFR 510.206 · Review of information supporting actions to establish or amend an import tolerance.
- 21 CFR 510.207 · Disclosure of information submitted in a request.
- 21 CFR 510.209 · Establishment, denial, or amendment of an import tolerance.
- 21 CFR 510.210 · Revocation of an import tolerance.
- 21 CFR 510.212 · Administrative reconsideration of action.
- 21 CFR 510.213 · Administrative stay of action.
- 21 CFR 510.301 · Records and reports concerning experience with animal feeds bearing or containing new animal drugs for which an approved medicated feed mill license application is in effect.
- 21 CFR 510.305 · Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs.
- 21 CFR 510.410 · Corticosteroids for oral, injectable, and ophthalmic use in animals; warnings and labeling requirements.
- 21 CFR 510.440 · Injectable iron preparations.
- 21 CFR 510.455 · Requirements for free-choice medicated feeds.
- 21 CFR 510.600 · Names, addresses, and drug labeler codes of sponsors of approved applications.
- 21 CFR 511.1 · New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act.
- 21 CFR 511.3 · Definitions.
- 21 CFR 514.1 · Applications.
- 21 CFR 514.3 · Definitions.
- 21 CFR 514.4 · Substantial evidence.
- 21 CFR 514.5 · Presubmission conferences.
- 21 CFR 514.6 · Amended applications.
- 21 CFR 514.7 · Withdrawal of applications without prejudice.
- 21 CFR 514.8 · Supplements and other changes to an approved application.
- 21 CFR 514.11 · Confidentiality of data and information in a new animal drug application file.
- 21 CFR 514.12 · Confidentiality of data and information in an investigational new animal drug notice.
- 21 CFR 514.15 · Untrue statements in applications.
- 21 CFR 514.80 · Records and reports concerning experience with approved new animal drugs.
- 21 CFR 514.87 · Annual reports for antimicrobial animal drug sales and distribution.
- 21 CFR 514.100 · Evaluation and comment on applications.
- 21 CFR 514.105 · Approval of applications.
- 21 CFR 514.106 · Approval of supplemental applications.
- 21 CFR 514.110 · Reasons for refusing to file applications.
- 21 CFR 514.111 · Refusal to approve an application.
- 21 CFR 514.115 · Withdrawal of approval of applications.
- 21 CFR 514.116 · Notice of withdrawal of approval of application.
- 21 CFR 514.117 · Adequate and well-controlled studies.
- 21 CFR 514.120 · Revocation of order refusing to approve an application or suspending or withdrawing approval of an application.
- 21 CFR 514.121 · Service of notices and orders.
- 21 CFR 514.200 · Notice of opportunity for hearing; notice of participation and requests for hearing; grant or denial of hearing.
- 21 CFR 514.201 · Procedures for hearings.
- 21 CFR 514.235 · Judicial review.
- 21 CFR 515.10 · Medicated feed mill license applications.
- 21 CFR 515.11 · Supplemental medicated feed mill license applications.
- 21 CFR 515.20 · Approval of medicated feed mill license applications.
- 21 CFR 515.21 · Refusal to approve a medicated feed mill license application.
- 21 CFR 515.22 · Suspension and/or revocation of approval of a medicated feed mill license.
- 21 CFR 515.23 · Voluntary revocation of medicated feed mill license.
- 21 CFR 515.24 · Notice of revocation of a medicated feed mill license.
- 21 CFR 515.25 · Revocation of order refusing to approve a medicated feed mill license application or suspending or revoking a license.
- 21 CFR 515.26 · Services of notices and orders.
- 21 CFR 515.30 · Contents of notice of opportunity for a hearing.
- 21 CFR 515.31 · Procedures for hearings.
- 21 CFR 515.40 · Judicial review.
- 21 CFR 516.1 · Scope.
- 21 CFR 516.2 · Purpose.
- 21 CFR 516.3 · Definitions.
- 21 CFR 516.11 · Scope of this subpart.
- 21 CFR 516.12 · Purpose.
- 21 CFR 516.13 · Definitions.
- 21 CFR 516.14 · Submission of requests for designation.
- 21 CFR 516.16 · Eligibility to request designation.
- 21 CFR 516.20 · Content and format of a request for MUMS-drug designation.
- 21 CFR 516.21 · Documentation of minor use status.
- 21 CFR 516.22 · Permanent-resident U.S. agent for foreign sponsor.
- 21 CFR 516.23 · Timing of requests for MUMS-drug designation.
- 21 CFR 516.24 · Granting MUMS-drug designation.
- 21 CFR 516.25 · Refusal to grant MUMS-drug designation.
- 21 CFR 516.26 · Amendment to MUMS-drug designation.
- 21 CFR 516.27 · Change in sponsorship.
- 21 CFR 516.28 · Publication of MUMS-drug designations.
- 21 CFR 516.29 · Termination of MUMS-drug designation.
- 21 CFR 516.30 · Annual reports for a MUMS-designated drug.
- 21 CFR 516.31 · Scope of MUMS-drug exclusive marketing rights.
- 21 CFR 516.34 · FDA recognition of exclusive marketing rights.
- 21 CFR 516.36 · Insufficient quantities of MUMS-designated drugs.
- 21 CFR 516.52 · Availability for public disclosure of data and information in requests.
- 21 CFR 516.111 · Scope of this subpart.
- 21 CFR 516.115 · Definitions.
- 21 CFR 516.117 · Submission of correspondence under this subpart.
- 21 CFR 516.119 · Permanent-resident U.S. agent for foreign requestors and holders.
- 21 CFR 516.121 · Meetings.
- 21 CFR 516.123 · Informal conferences regarding agency administrative actions.
- 21 CFR 516.125 · Investigational use of minor species new animal drugs to support indexing.
- 21 CFR 516.129 · Content and format of a request for determination of eligibility for indexing.
- 21 CFR 516.131 · Refuse to file a request for determination of eligibility for indexing.
- 21 CFR 516.133 · Denying a request for determination of eligibility for indexing.
- 21 CFR 516.135 · Granting a request for determination of eligibility for indexing.
- 21 CFR 516.137 · Notification of decision regarding eligibility for indexing.
- 21 CFR 516.141 · Qualified expert panels.
- 21 CFR 516.143 · Written report.
- 21 CFR 516.145 · Content and format of a request for addition to the index.
- 21 CFR 516.147 · Refuse to file a request for addition to the index.
- 21 CFR 516.149 · Denying a request for addition to the index.
- 21 CFR 516.151 · Granting a request for addition to the index.
- 21 CFR 516.153 · Notification of decision regarding index listing.
- 21 CFR 516.155 · Labeling of indexed drugs.
- 21 CFR 516.157 · Publication of the index and content of an index listing.
- 21 CFR 516.161 · Modifications to indexed drugs.
- 21 CFR 516.163 · Change in ownership of an index file.