[Federal Register Volume 69, Number 154 (Wednesday, August 11, 2004)]
[Rules and Regulations]
[Pages 48774-48776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18224]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0287]

21 CFR Parts 1, 5, 26, 203, 207, and 314


Change of Names and Addresses; 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 
regulations to reflect name and address changes for the Office of 
Compliance, Center for Drug Evaluation and Research (CDER). This action 
is editorial in nature and is intended to provide accuracy and clarity 
to the agency's regulations.

EFFECTIVE DATE:  August 11, 2004.

FOR FURTHER INFORMATION CONTACT: Mary C. Hennessey, Office of 
Compliance, Center for Drug Evaluation and Research (HFD-300), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
8910.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations in 21 CFR 
parts 1, 5, 26, 203, 207, and 314 to reflect name and address changes 
for certain divisions of the Office of Compliance, CDER. The name 
changes are the result of a reorganization in CDER's Office of 
Compliance to improve coordination and communication and to enhance the 
office's capacity to implement risk management approaches to compliance 
activities. The address changes are due to the relocation of CDER's 
Office of Compliance.
    Under this reorganization, the following organizational changes are 
reflected in the amendments made by this final rule:
     The name of the former Division of Labeling and 
Nonprescription Drug Compliance has been changed to the Division of New 
Drugs and Labeling Compliance,
     The name of the former Division of Prescription Drug 
Compliance and Surveillance has been changed to the Division of 
Compliance Risk Management and Surveillance, and
     Information sent to or obtained from the Drug Listing 
Branch is now maintained and distributed by CDER's Records Repository 
Team.
    The amendments also include:
     The new mailing address of the Office of Compliance, CDER, 
and
     The new mailing addresses of specific divisions within the 
Office of Compliance (CDER) and for the Records Repository Team.
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). Notice 
and public procedure are unnecessary because these amendments are 
nonsubstantive.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 5

    Authority delegations (Government agencies), Imports, Organization 
and functions (Government agencies).

21 CFR Part 26

    Animal drugs, Biologics, Drugs, Exports, Imports.

21 CFR Part 203

    Labeling, Prescription drugs, Reporting and recordkeeping 
requirements, Warehouses.

21 CFR Part 207

    Drugs, Reporting and recordkeeping requirements.

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 parts 
1, 5, 26, 203, 207, and 314 are amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

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

    Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21 
U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355, 
360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 
264.

0
2. Section 1.101 is amended by revising paragraph (d)(2)(ii) to read as 
follows:


Sec.  1.101  Notification and recordkeeping.

* * * * *

[[Page 48775]]

    (d) * * *
    (2) * * *
    (ii) For human drug products--Division of New Drugs and Labeling 
Compliance (HFD-310), Office of Compliance, Center for Drug Evaluation 
and Research, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857.
* * * * *

PART 5--ORGANIZATION

0
3. The authority citation for 21 CFR part 5 continues to read as 
follows:

    Authority: 5 U.S.C. 552; 21 U.S.C. 301-397.


Sec.  5.1100  [Amended]

0
4. Section 5.1100 is amended under the heading ``CENTER FOR DRUG 
EVALUATION AND RESEARCH.\1\'' by removing the entries
``Office of Compliance.\6\
Division of Manufacturing and Product Quality.
Division of Prescription Drug Compliance and Surveillance.
Division of Labeling and Non-Prescription Drug Compliance.'' and by 
adding in its place the entries
``Office of Compliance.\1\
Division of New Drugs and Labeling Compliance (HFD-310).
Division of Manufacturing and Product Quality (HFD-320).
Division of Compliance Risk Management and Surveillance (HFD-330).''

PART 26--MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING 
PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND 
CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES 
AND THE EUROPEAN COMMUNITY

0
5. The authority citation for 21 CFR part 26 continues to read as 
follows:

    Authority: 5 U.S.C. 552; 15 U.S.C. 1453, 1454, 1455; 18 U.S.C. 
1905; 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 360c, 360d, 
360e, 360f, 360g, 360h, 360i, 360j, 360l, 360m, 371, 374, 381, 382, 
383, 393; 42 U.S.C. 216, 241, 242l, 262, 264, 265.
0
6. Appendix E to Subpart A of part 26 is amended under the heading ``B. 
For the United States:'' in the entry for ``Human Drugs'' by removing 
the phrase ``MPN I, 7520 Standish Pl., Rockville, MD 20855-2737, phone: 
301-594-0054, fax: 301-594-2114'' and by adding in its place the phrase 
``5600 Fishers Lane, Rockville, MD 20857, phone: 301-827-8910, fax: 
301-827-8901''.

PART 203--PRESCRIPTION DRUG MARKETING

0
7. The authority citation for 21 CFR part 203 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 333, 351, 352, 353, 360, 371, 374, 
381.


Sec.  203.12  [Amended]

0
8. Section 203.12 is amended in the first sentence by removing the 
phrase ``7520 Standish Pl., Rockville, MD 20855'' and by adding in its 
place the phrase ``5600 Fishers Lane, Rockville, MD 20857''.

0
9. Section 203.37 is amended by revising the first sentence of 
paragraph (e) to read as follows:


Sec.  203.37  Investigation and notification requirements.

* * * * *
    (e) Whom to notify at FDA. Notifications and reports concerning 
prescription human drugs shall be made to the Division of Compliance 
Risk Management and Surveillance (HFD-330), Office of Compliance, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857. * * *


Sec.  203.70  [Amended]

0
10. Section 203.70 is amended in paragraph (b)(1) by removing the 
phrase ``7500 Standish Pl., Rockville, MD 20855'' and by adding in its 
place the phrase ``5600 Fishers Lane, Rockville, MD 20857''.

PART 207--REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS 
IN COMMERCIAL DISTRIBUTION

0
11. The authority citation for 21 CFR part 207 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 
374, 381, 393; 42 U.S.C. 262, 264, 271.


Sec.  207.7  [Amended]

0
12. Section 207.7 is amended in paragraph (d) by removing the phrase 
``Drug Listing Branch (HFD-334)'' and by adding in its place the phrase 
``Records Repository Team (HFD-143)''.


Sec.  207.22  [Amended]

0
13. Section 207.22 is amended in paragraph (a) by removing the phrase 
``Drug Listing Branch (HFD-334)'' and by adding in its place the phrase 
``Records Repository Team (HFD-143)''; and in paragraph (b) by removing 
the phrase ``Drug Listing Branch (HFD-334)'' and by adding in its place 
the phrase ``Records Repository Team (HFD-143)''.

0
14. Section 207.37 is amended by revising the introductory text of 
paragraph (a) to read as follows:


Sec.  207.37  Inspection of registrations and drug listings.

    (a) A copy of the Form FDA-2656 (Registration of Drug 
Establishment) filed by the registrant will be available for inspection 
in accordance with section 510(f) of the act, at the Records Repository 
Team (HFD-143), Center for Drug Evaluation and Research, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857. In addition, 
copies of these forms for establishments located within a particular 
geographic area are available for inspection at FDA district offices 
responsible for that geographical area. Copies of forms submitted by 
foreign drug establishments are available for inspection at the 
Division of Manufacturing and Product Quality, Foreign Inspection Team 
(HFD-325), Office of Compliance, Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857. Upon request and receipt of a stamped, self-addressed 
envelope, the Records Repository Team, the Foreign Inspection Team, or 
the appropriate FDA district office will verify registration numbers or 
provide the location of a registered establishment. The mailing address 
for the Foreign Inspection Team is: Division of Manufacturing and 
Product Quality, Office of Compliance, Center for Drug Evaluation and 
Research (HFD-325), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857.
* * * * *

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

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

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


Sec.  314.81  [Amended]

0
16. Section 314.81 is amended in paragraph (b)(3)(iii)(b) by removing 
the phrase ``Drug Listing Branch (HFD-334)'' and by adding in its place 
the phrase ``Records Repository Team (HFD-143)''.


Sec.  314.200  [Amended]

0
17. Section 314.200 is amended in the second sentence of paragraph 
(a)(3) by removing the phrase ``Division of Drug Labeling Compliance 
(HFD-310)'' and by adding in its place the phrase ``Division of New 
Drugs and Labeling

[[Page 48776]]

Compliance (HFD-310), Office of Compliance''.

    Dated: August 3, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-18224 Filed 8-10-04; 8:45 am]
BILLING CODE 4160-01-S