Source: https://www.federalregister.gov/documents/2009/03/06/E9-4813/new-drug-applications-and-abbreviated-new-drug-applications-technical-amendment
Timestamp: 2017-09-26 18:46:47
Document Index: 771045278

Matched Legal Cases: ['§\u2009314', '§\u2009314', '§\u2009314', '§\u2009314', '§\u2009314', 'art 56', 'art 58', 'art 56', 'art 58', 'art 56']

Federal Register :: New Drug Applications and Abbreviated New Drug Applications; Technical Amendment
https://www.federalregister.gov/d/E9-4813 https://www.federalregister.gov/d/E9-4813
In §§ 314.52(a)(2) and 314.95(a)(2), FDA is updating the agency contact for obtaining the name and address of the NDA holder or designee for purposes of providing notice of a patent certification submitted under section 505(b)(2)(A)(iv) Start Printed Page 9766or 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV)). The Division of Drug Information Resources no longer exists. The agency contact for this information is now the Orange Book Staff, Office of Generic Drugs.
In § 314.53(f), FDA is updating the agency unit to which notifications of requests for correction of patent information should be directed. The Drug Information Services Branch no longer exists. These notifications should now be sent to the Office of Generic Drugs Document Room, attention the Orange Book Staff.
In § 314.107(e), FDA is updating the listing of agency units to which a 505(b)(2) applicant must send notification of entry of an order or judgment in a court action. Instead of the appropriate division in the Office of Drug Evaluation I and Office of Drug Evaluation II, these notifications should now be sent to the appropriate division in the Office of New Drugs.
In § 314.107(f)(2)(iv), FDA is updating the agency recipient of a 505(b)(2) applicant's required notification that a legal action has been filed within 45 days of receipt of a notice of paragraph IV certification (submitted under section 505(b)(2)(A)(iv) of the act) from the appropriate division in the Center for Drug Evaluation and Research to the appropriate division in the Office of New Drugs.
In § 314.125(b)(16), FDA is correcting a cross-reference to the agency's regulations on institutional review boards (21 CFR part 56) by replacing “part 58” with “part 56.”
2. Section 314.52 is amended in paragraph (a)(2) by removing “Division of Drug Information Resources (HFD-80), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857” and by adding in its place “Orange Book Staff, Office of Generic Drugs, at the address identified on FDA's Web site (
3. Section 314.53 is amended in paragraph (f) by removing “Drug Information Services Branch (HFD-84), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857” and by adding in its place “Office of Generic Drugs, OGD Document Room, Attention: Orange Book Staff, at the address identified on FDA's Web site (
4. Section 314.95 is amended in paragraph (a)(2) by removing “Division of Drug Information Resources (HFD-80), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857” and by adding in its place “Orange Book Staff, Office of Generic Drugs, at the address identified on FDA's Web site (
5. Section 314.107 is amended in paragraph (e) by removing “Office of Drug Evaluation I (HFD-100) or Office of Drug Evaluation II (HFD-500), whichever is applicable,” and by adding in its place “Office of New Drugs” and in paragraph (f)(2)(iv) by removing “Center for Drug Evaluation and Research” and by adding in its place “Office of New Drugs”.
6. Section 314.125 is amended in paragraph (b)(16) by removing “part 58” and by adding in its place “part 56”.