[Federal Register Volume 74, Number 57 (Thursday, March 26, 2009)]
[Rules and Regulations]
[Pages 13111-13114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-6795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 26, 201, 203, 206, 310, 312, 314, 320, and 600

[Docket No. FDA-2009-N-0133]


Change of Addresses and Names; 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 a change of address for the Center for Drug 
Evaluation and Research's (CDER's) Central Document Room in Beltsville, 
MD; the relocation of certain CDER offices to the White Oak campus in 
Silver Spring, MD; and changes of the names of certain CDER 
organizational units. This action is editorial in nature and is 
intended to ensure the accuracy and clarity of the agency's 
regulations.

DATES: This rule is effective March 26, 2009.

FOR FURTHER INFORMATION CONTACT: Wendy Aaronson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 1128, Silver Spring, MD 20993-0002, 301-
796-0410.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations in parts 1, 
26, 201, 203, 206, 310, 312, 314, 320, and 600 (21 CFR parts 1, 26, 
201, 203, 206, 310, 312, 314, 320, and 600) to reflect the following 
changes: (1) Names of certain CDER organizational units; (2) a change 
of address for CDER's Central Document Room in Beltsville, MD; and (3) 
the relocation of certain CDER offices to the White Oak campus in 
Silver Spring, MD. The addresses are locations to which applicants must 
submit information related to marketing applications or products 
regulated by CDER or from which the public can request information. 
Where appropriate, Internet addresses for obtaining information and 
forms are added and outdated addresses are removed.
    The technical amendments made by this document are largely related 
to paper submissions; however, FDA is committed to adapting its 
business practices to evolving technology, including using the 
significant advancements in Web-based, electronic systems. We 
anticipate that, in future rulemakings, Web-based filing of most 
submissions will eventually be required. We anticipate that when a 
change to an electronic submission system is implemented, we will 
provide guidance to address any technical questions related to such 
submissions.
    The technical amendments, reflected in the regulatory text of this 
final rule, are as follows:
     In Sec.  1.101(d)(2)(ii), the address to submit 
notifications for products regulated by CDER exported under section 802 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 382) is changed 
to the White Oak campus.
     In Appendix E to subpart A of part 26, the contact 
information for CDER's Office of Compliance is updated to the White Oak 
campus.
     In Sec.  201.58, the address to submit requests for 
waivers of labeling requirements is updated to the Beltsville Central 
Document Room.
     In Sec.  203.12, the CDER address for notification of an 
appeal from an adverse decision regarding reimportation of an insulin-
containing or prescription drug by a district office is changed to the 
White Oak campus.
     In Sec.  203.37(e), the address to submit information 
regarding falsification of drug sample records or loss or theft of 
samples for prescription drugs and biological products regulated by 
CDER is changed to the White Oak campus.
     In Sec.  203.70(b)(1), the address to apply for a reward 
for providing information leading to a criminal proceeding or 
conviction related to the sale, purchase, or trade of a drug sample is 
changed to the White Oak campus.
     In Sec.  206.7(b)(1)(i), the address to request exemptions 
from imprinting requirements for solid oral dosage form drugs is 
updated to the Beltsville Central Document Room.
     In Sec.  310.6(e), the address for interested parties to 
submit the names of drug products, and of their manufacturers or 
distributors, that should be subject to the same purchasing and 
regulatory policies as those reviewed by the Drug Efficacy Study Group 
is changed to the White Oak campus.
     In Sec. Sec.  310.305(c) and 314.98(b), the address to 
submit postmarketing safety reports is updated to the Beltsville 
Central Document Room. (Note that applicants and any person other than 
the applicant whose name appears on the label of an approved drug 
product as a manufacturer, packer, or distributor may also elect to 
submit postmarketing safety reports in electronic format.)
     In Sec. Sec.  310.305(d)(4) and 314.80(f)(4), the address 
to obtain reporting forms is updated to reflect Internet availability.
     In Sec. Sec.  310.501(e) and 310.515(d), the name and 
address to request labeling guidance for estrogen drug products are 
updated to the Division of Reproductive and Urologic Products and the 
White Oak campus.
     In Sec.  312.140(b), mailing instructions are updated to 
ensure submissions are addressed properly.
     In Sec. Sec.  312.145(b) and 314.445(b), the CDER unit 
from which to request a list of CDER guidances is updated to the 
Division of Drug Information. The address is updated to the White Oak 
campus, and an Internet address is added to reflect the availability of 
the list on the Internet.
     In Sec.  314.80(d)(2) and (f)(3)(ii), the CDER unit to 
contact regarding alternative reporting formats is updated to the 
Office of Surveillance and Epidemiology.
     In Sec.  314.81(b)(3)(i), the address to obtain Form FDA-
2253 (Transmittal of Advertisements and Promotional Labeling for Drugs 
for Human Use) is updated to reflect Internet availability.
     In Sec.  314.200(a)(3), the address to request opinions of 
the applicability of a notice of opportunity for a hearing published in 
the Federal Register to a specific product that may be identical, 
related, or similar to a product listed in the notice is changed to the 
White Oak campus.
     In Sec.  314.440(a), an outdated address to submit 
applications, abbreviated applications, and related

[[Page 13112]]

correspondence is removed and in Sec.  314.440(a)(1), mailing 
instructions are updated to ensure submissions are addressed properly 
and the address to obtain folders for binding applications is updated 
to reflect information available at an Internet address.
     In Sec.  320.30(c)(1), the name and address to submit 
general inquiries related to bioavailability requirements and 
methodology are updated to the Office of Clinical Pharmacology and the 
White Oak campus.
     In Sec.  600.2(b)(1), the address for submitting 
biological product deviation reports for biological products regulated 
by CDER is changed to the White Oak campus.
     In Sec.  600.2(b)(3), the address for submitting 
advertising and promotional labeling supplements required under Sec.  
600.12(f) is updated to the Beltsville Central Document Room.
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has 
determined that notice and public comment are unnecessary because this 
amendment to the regulations provides only technical changes to update 
names and addresses of CDER organizational units.

List of Subjects

21 CFR Part 1

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

21 CFR Part 26

    Animal drugs, Biologics, Drugs, Exports, Imports.

21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 203

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

21 CFR Part 206

    Drugs.

21 CFR Part 310

    Administrative practice and procedure, Drugs, Labeling, Medical 
devices, Reporting and recordkeeping requirements.

21 CFR Part 312

    Drugs, Exports, Imports, Investigations, Labeling, Medical 
research, Reporting and recordkeeping requirements, Safety.

21 CFR Part 314

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

21 CFR Part 320

    Drugs, Reporting and recordkeeping requirements.

21 CFR Part 600

    Biologics, 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, 26, 201, 203, 206, 310, 312, 314, 320, and 600 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, 333, 334, 335a, 343, 350c, 350d, 352, 355, 360b, 
362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 264.


Sec.  1.101  [Amended]

0
2. Section 1.101 is amended in paragraph (d)(2)(ii) by removing ``(HFD-
310)''; and by removing ``5600 Fishers Lane, Rockville, MD 20857'' and 
adding in its place ``10903 New Hampshire Ave., Silver Spring, MD 
20993-0002''.

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
3. 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
4. Appendix E to subpart A of part 26 is amended under the heading ``B. 
Forthe United States:'' in the entry for ``Human Drugs'' by removing 
``(HFD-300), 5600 Fishers Lane, Rockville, MD 20857, phone: 301-827-
8910, fax: 301-827-8901'' and by adding in its place ``10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, phone: 301-796-3100, fax: 
301-847-8747''.

PART 201--LABELING

0
5. The authority citation for 21 CFR part 201 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.


Sec.  201.58  [Amended]

0
6. Section 201.58 is amended in the second sentence by removing ``5600 
Fishers Lane, Rockville, MD 20857'' and by adding in its place 
``Central Document Room, 5901-B Ammendale Rd., Beltsville, MD 20705-
1266''.

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 by removing ``(HFD-300)'' both times it 
appears; and by removing ``5600 Fishers Lane, Rockville, MD 20857'' 
both times it appears and adding in its place ``10903 New Hampshire 
Ave., Silver Spring, MD 20993-0002''.


Sec.  203.37  [Amended]

0
9. Section 203.37 is amended in the first sentence of paragraph (e) by 
removing ``(HFD-330)''; and by removing ``5600 Fishers Lane, Rockville, 
MD 20857'' and adding in its place ``10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002''.


Sec.  203.70  [Amended]

0
10. Section 203.70 is amended in paragraph (b)(1) by removing ``(HFD-
300)''; and by removing ``5600 Fishers Lane, Rockville, MD 20857'' and 
adding in its place ``10903 New Hampshire Ave., Silver Spring, MD 
20993-0002''.

PART 206--IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR 
HUMAN USE

0
11. The authority citation for 21 CFR part 206 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 355, 371; 42 U.S.C. 262.


Sec.  206.7  [Amended]

0
12. Section 206.7 is amended in paragraph (b)(1)(i) by removing ``5600 
Fishers Lane, Rockville, MD 20857'' and by adding in its place ``5901-B 
Ammendale Rd., Beltsville, MD 20705-1266''.

PART 310--NEW DRUGS

0
13. The authority citation for 21 CFR part 310 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 
360j, 361(a), 371, 374,

[[Page 13113]]

375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 263b-263n.


Sec.  310.6  [Amended]

0
14. Section 310.6 is amended in the first sentence of paragraph (e) by 
removing ``HFD-300, 5600 Fishers Lane, Rockville, MD 20857'' and by 
adding in its place ``10903 New Hampshire Ave., Silver Spring, MD 
20993-0002''.

0
15. Section 310.305 is amended in paragraph (c) by removing ``Division 
of Pharmacovigilance and Epidemiology (HFD-730)'' and by adding in its 
place ``Central Document Room''; by removing ``5600 Fishers Lane, 
Rockville, MD 20857'' and by adding in its place ``5901-B Ammendale 
Rd., Beltsville, MD 20705-1266''; and by revising paragraph (d)(4) to 
read as follows:


Sec.  310.305  Records and reports concerning adverse drug experiences 
on marketed prescription drugs for human use without approved new drug 
applications.

* * * * *
    (d) * * *
    (4) FDA Form 3500A and instructions for completing the form are 
available on the Internet at http://www.fda.gov/medwatch/index.html.
* * * * *


Sec.  310.501  [Amended]

0
16. Section 310.501 is amended in paragraph (e) by removing 
``Metabolism and Endocrine Drug Products (HFD-510)'' and by adding in 
its place ``Reproductive and Urologic Products'' and by removing ``5600 
Fishers Lane, Rockville, MD 20857'' and by adding in its place ``10903 
New Hampshire Ave., Silver Spring, MD 20993-0002''.


Sec.  310.515  [Amended]

0
17. Section 310.515 is amended in the second sentence of paragraph (d) 
by removing ``Metabolism and Endocrine Drug Products (HFD-510)'' and by 
adding in its place ``Reproductive and Urologic Products'' and by 
removing ``5600 Fishers Lane, Rockville, MD 20857'' and by adding in 
its place ``10903 New Hampshire Ave., Silver Spring, MD 20993-0002''.

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION

0
18. The authority citation for 21 CFR part 312 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 371, 
381, 383, 393; 42 U.S.C. 262.


Sec.  312.140  [Amended]

0
19. Section 312.140 is amended in the second sentence of paragraph (b) 
by removing ``directed to the appropriate Center and division'' and by 
adding in its place ``sent to the appropriate center at the address 
indicated in this section and marked to the attention of the 
responsible division''.


Sec.  312.145  [Amended]

0
20. Section 312.145 is amended in the third sentence of paragraph (b) 
by removing ``Division of Communications Management, Drug Information 
Branch (HFD-210)'' and by adding in its place ``Division of Drug 
Information'' and by removing ``5600 Fishers Lane, Rockville, MD 
20857'' and by adding in its place ``10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002''.

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

0
21. 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.

0
22. Section 314.80 is amended as follows:
0
a. In the second sentence of paragraph (d)(2), by removing ``Division 
of Pharmacovigilance and Epidemiology'' and by adding in its place 
``Office of Surveillance and Epidemiology''; and
0
b. By revising paragraphs (f)(3)(ii) and (f)(4) to read as follows:
    The revisions read as follows:


Sec.  314.80  Postmarketing reporting of adverse drug experiences.

* * * * *
    (f) * * *
    (3) * * * (ii) The format is agreed to in advance by the Office of 
Surveillance and Epidemiology.
    (4) FDA Form 3500A and instructions for completing the form are 
available on the Internet at http://www.fda.gov/medwatch/index.html.
* * * * *

0
23. Section 314.81 is amended by revising the last sentence of 
paragraph (b)(3)(i) to read as follows:


Sec.  314.81  Other postmarketing reports.

* * * * *
    (b) * * *
    (3) * * *
    (i) * * *Form FDA-2253 is available on the Internet at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html.
* * * * *


Sec.  314.98  [Amended]

0
24. Section 314.98 is amended in paragraph (b) by removing ``Division 
of Epidemiology and Surveillance (HFD-730)'' and by adding in its place 
``Central Document Room'' and by removing ``5600 Fishers Lane, 
Rockville, MD 20857'' and by adding in its place ``5901-B Ammendale 
Rd., Beltsville, MD 20705-1266''.


Sec.  314.200  [Amended]

0
25. Section 314.200 is amended in the second sentence of paragraph 
(a)(3) by removing ``(HFD-310)''; and by removing ``5600 Fishers Lane, 
Rockville, MD 20857'' and adding in its place ``10903 New Hampshire 
Ave., Silver Spring, MD 20993-0002''.

0
26. Section 314.440 is amended by revising paragraph (a) introductory 
text, and paragraph (a)(1) to read as follows:


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 Sec.  314.50 or Sec.  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.
* * * * *


Sec.  314.445  [Amended]

0
27. Section 314.445 is amended in the third sentence of paragraph (b) 
by removing ``Division of Communications Management, Drug Information 
Branch (HFD-210)'' and by adding in its place ``Division of Drug 
Information'' and by removing ``5600 Fishers Lane, Rockville, MD 
20857'' and by adding in its place ``10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002''.

PART 320--BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

0
28. The authority citation for 21 CFR part 320 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 351, 352, 355, 371.

[[Page 13114]]

Sec.  320.30  [Amended]

0
29. Section 320.30 is amended in paragraph (c)(1) by removing ``and 
Biopharmaceutics (HFD-850), 5600 Fishers Lane, Rockville, MD 20857'' 
and by adding in its place ``, 10903 New Hampshire Ave., Silver Spring, 
MD 20993-0002''.

PART 600--BIOLOGICAL PRODUCTS: GENERAL

0
30. The authority citation for 21 CFR part 600 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 351, 352, 355, 360, 360i, 371, 374; 42 
U.S.C. 216, 262, 263, 263a, 264, 300aa-25.


Sec.  600.2  [Amended]

0
31. Section 600.2 is amended as follows:
    a. In paragraph (b)(1) by removing ``(HFD-330)''; and by removing 
``5600 Fishers Lane, Rockville, MD 20857'' and adding in its place 
``10903 New Hampshire Ave., Silver Spring, MD 20993-0002''; and
    b. In paragraph (b)(3) by removing ``(HFD-42)''; and by removing 
``5600 Fishers Lane, rm. 8B45, Rockville, MD 20857'' and adding in its 
place ``5901-B Ammendale Rd., Beltsville, MD 20705-1266''.

    Dated: March 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-6795 Filed 3-25-09; 8:45 am]
BILLING CODE 4160-01-S