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[A2]
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Electronic Code of Federal Regulations
| e-CFR data is current as of February 21, 2020
TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A—GENERAL PART 99—DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
Subpart A—GENERAL INFORMATION
Subpart B—INFORMATION TO BE DISSEMINATED
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| Information that may be disseminated. |
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| Mandatory statements and information. |
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| Recipients of information. |
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Subpart C—MANUFACTURER'S SUBMISSIONS, REQUESTS, AND APPLICATIONS
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| Manufacturer's submission to the agency. |
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| Request to extend the time for completing planned studies. |
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| Application for exemption from the requirement to file a supplemental application. |
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Subpart D—FDA ACTION ON SUBMISSIONS, REQUESTS, AND APPLICATIONS
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| Agency action on a submission. |
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| Extension of time for completing planned studies. |
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| Exemption from the requirement to file a supplemental application. |
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Subpart E—CORRECTIVE ACTIONS AND CESSATION OF DISSEMINATION
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| Corrective actions and cessation of dissemination of information. |
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| Termination of approvals of applications for exemption. |
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| Applicability of labeling, adulteration, and misbranding authority. |
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Subpart F—RECORDKEEPING AND REPORTS
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| Recordkeeping and reports. |
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