[Federal Register Volume 74, Number 43 (Friday, March 6, 2009)]
[Rules and Regulations]
[Pages 9765-9766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4813]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314

[Docket No. FDA-2009-N-0099]


New Drug Applications and Abbreviated New Drug Applications; 
Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending its new 
drug application (NDA) and abbreviated new drug application (ANDA) 
regulations to update agency contacts for patent information and patent 
notifications and to correct an inaccurate cross-reference. This action 
is being taken to ensure accuracy and clarity in the agency's 
regulations.

DATES: This rule is effective March 6, 2009.

FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug 
Evaluation and Research, Food and Drug Administration, Bldg. 51, rm. 
6308, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
3506.

SUPPLEMENTARY INFORMATION: FDA is amending its NDA and ANDA regulations 
in part 314 (21 CFR part 314) to update agency contacts for information 
and notifications pertaining to patents and to correct an inaccurate 
reference. To accommodate the ongoing relocation of FDA offices, users 
are directed to FDA's Web site to obtain the current address of the 
Office of Generic Drugs.
    In Sec. Sec.  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)

[[Page 9766]]

or 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 Sec.  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 Sec.  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 Sec.  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 Sec.  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.''
    Publication of this document constitutes final action under the 
Administrative Procedure Act (5 U.S.C. 553). FDA has determined that 
notice and public comment are unnecessary because the amendments to the 
regulations provide only technical changes to correct an inaccurate 
citation and to update agency contacts, and are nonsubstantive.

List of Subjects in 21 CFR Part 314

    Administrative practice and procedure, Confidential business 
information, Drugs, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
314 is amended as follows:

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

0
1. The authority citation for 21 CFR part 314 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a, 
356b, 356c, 371, 374, 379e.


Sec.  314.52  [Amended]

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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 (http://www.fda.gov/cder/ogd)''.


Sec.  314.53  [Amended]

0
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 (http://www.fda.gov/cder/ogd)''.


Sec.  314.95  [Amended]

0
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 (http://www.fda.gov/cder/ogd)''.


Sec.  314.107  [Amended]

0
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''.


Sec.  314.125  [Amended]

0
6. Section 314.125 is amended in paragraph (b)(16) by removing ``part 
58'' and by adding in its place ``part 56''.

    Dated: February 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy.
[FR Doc. E9-4813 Filed 3-5-09; 8:45 am]
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