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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: 21CFR314.440]



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 G--Miscellaneous Provisions

Sec. 314.440 Addresses for applications and abbreviated applications.

(a) Applicants shall send applications, abbreviated applications, and other correspondence relating to matters covered by this part, except for products listed in paragraph (b) of this section, to the appropriate office identified below:

(1) Except as provided in paragraph (a)(4) of this section, an application under 314.50 or 314.54 submitted for filing should be directed to the Central Document Room, 5901-B Ammendale Rd., Beltsville, MD 20705-1266. Applicants may obtain information about folders for binding applications on the Internet at http://www.fda.gov/cder/ddms/binders.htm . After FDA has filed the application, the agency will inform the applicant which division is responsible for the application. Amendments, supplements, resubmissions, requests for waivers, and other correspondence about an application that has been filed should be addressed to 5901-B Ammendale Rd., Beltsville, MD 20705-1266, to the attention of the appropriate division.

(2) Except as provided in paragraph (a)(4) of this section, an abbreviated application under 314.94, and amendments, supplements, and resubmissions should be directed to the Office of Generic Drugs (HFD-600), Center for Drug Evaluation and Research, Food and Drug Administration, Metro Park North VII, 7620 Standish Pl., Rockville, MD 20855. This includes items sent by parcel post or overnight courier service. Correspondence not associated with an abbreviated application should be addressed specifically to the intended office or division and to the person as follows: Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Attn: [insert name of person], Metro Park North II, HFD-[insert mail code of office or division], 7500 Standish Place, rm. 150, Rockville, MD 20855. The mail code for the Office of Generic Drugs is HFD-600, the mail codes for the Divisions of Chemistry I, II, and III are HFD-620, HFD-640, and HFD-630, respectively, and the mail code for the Division of Bioequivalence is HFD-650.

(3) A request for an opportunity for a hearing under 314.110 on the question of whether there are grounds for denying approval of an application, except an application under paragraph (b) of this section, should be directed to the Associate Director for Policy (HFD-5).

(4) The field copy of an application, an abbreviated application, amendments, supplements, resubmissions, requests for waivers, and other correspondence about an application and an abbreviated application shall be sent to the applicant's home FDA district office, except that a foreign applicant shall send the field copy to the appropriate address identified in paragraphs (a)(1) and (a)(2) of this section.

(b) Applicants shall send applications and other correspondence relating to matters covered by this part for the drug products listed below to the Document Control Center (HFM-99), Center for Biologics Evaluation and Research, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, except applicants shall send a request for an opportunity for a hearing under 314.110 on the question of whether there are grounds for denying approval of an application to the Director, Center for Biologics Evaluation and Research (HFM-1), at the same address.

(1) Ingredients packaged together with containers intended for the collection, processing, or storage of blood and blood components;

(2) Plasma volume expanders and hydroxyethyl starch for leukapheresis;

(3) Blood component processing solutions and shelf life extenders; and

(4) Oxygen carriers.

[50 FR 7493, Feb. 22, 1985, as amended at 50 FR 21238, May 23, 1985; 55 FR 11581, Mar. 29, 1990; 57 FR 17997, Apr. 28, 1992; 58 FR 47352, Sept. 8, 1993; 62 FR 43639, Aug. 15, 1997; 69 FR 13473, Mar. 23, 2004; 70 FR 14981, Mar. 24, 2005; 73 FR 39610, July 10, 2008; 74 FR 13113, Mar. 26, 2009; 75 FR 37295, June 29, 2010]

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