21 C.F.R. § 314.440 Addresses for applications and abbreviated applications.
Title 21 - Food and Drugs
(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 Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, and directed 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 Document and Records Section, 5901–B Ammendale Rd., Beltsville, MD 20705–1266. Applicants may obtain folders for binding applications from the Consolidated Forms and Publications Distribution Center, Washington Commerce Center, 3222 Hubbard Rd., Landover, MD 20785. 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 directed to 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, 5600 Fishers Lane, Rockville, MD 20857. Items sent by parcel post or overnight courier service should be directed to the Office of Generic Drugs (HFD–600), Center for Drug Evaluation and Research, Food and Drug Administration, Metro Park North II, 7500 Standish Place, rm. 150, Rockville, MD 20855. Correspondence not associated with an application should be addressed specifically to the intended office or division and to the person as follows: Center for Drug Evaluation and Research, Food and Drug Administration, Attn: [insert name of person], MPN II, HFD–[insert mail code of office or division], 5600 Fishers Lane, Rockville, MD 20857. The mail code for the Office of Generic Drugs is HFD–600, the mail code for the Division of Chemistry is HFD–630, and the mail code for the Division of Bioequivalence is HFD–650. (3) A request for an opportunity for a hearing under §314.110 or §314.120 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 or §314.120 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]
Title 21: Food and Drugs
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart G—Miscellaneous Provisions
§ 314.440 Addresses for applications and abbreviated applications.
