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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2014]
[CITE: 21CFR314.99]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE

PART 314 -- APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

Subpart C--Abbreviated Applications

Sec. 314.99 Other responsibilities of an applicant of an abbreviated application.

(a) An applicant shall comply with the requirements of 314.65 regarding withdrawal by the applicant of an unapproved abbreviated application and 314.72 regarding a change in ownership of an abbreviated application.

(b) An applicant may ask FDA to waive under this section any requirement that applies to the applicant under 314.92 through 314.99. The applicant shall comply with the requirements for a waiver under 314.90.

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