[Federal Register Volume 70, Number 56 (Thursday, March 24, 2005)]
[Rules and Regulations]
[Pages 14978-14986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5780]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 25, 26, 99, 201, 203, 206, 310, 312, 314, 600, 601, 
606, 607, 610, 640, 660, 680, 807, and 822


Food and Drug Administration Regulations; Drug and Biological 
Product Consolidation; Addresses; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending certain 
regulations regarding biological products to include references to the 
Center for Drug Evaluation and Research (CDER) or the Director, CDER, 
and to include CDER address information or updated CDER address 
information, where appropriate. FDA is also amending the regulations to 
update mailing address information including mailing codes for the 
Center for Biologics Evaluation and Research (CBER), and to place the 
current mailing addresses for certain biologics regulations in a single 
location. These changes, among others, are being taken to reflect the 
reorganization between CBER and CDER due to the transfer of 
responsibility for certain products from CBER to CDER, and to ensure 
the consistency and accuracy of the regulations.

DATES: This rule is effective March 24, 2005.

FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

A. Transfer of Regulatory Responsibility from the Center for Biologics 
Evaluation and Research to the Center for Drug Evaluation and Research

    In a letter dated June 20, 2003, FDA notified sponsors that the 
regulatory responsibility, review, and continuing oversight for many 
biological products would be transferred from CBER to CDER. This change 
in regulatory responsibility resulted in the transfer of applications 
for the affected product classes (see section I.B of this document). 
This consolidation initiative was undertaken to provide greater 
opportunities to further develop and coordinate scientific and 
regulatory activities between CBER and CDER, leading to a more 
efficient, effective, and consistent review program for human drugs and 
biologics.
    In the Federal Register of June 26, 2003 (68 FR 38067), we 
published a notice announcing the transfer of certain product oversight 
from CBER to CDER. On June 30, 2003, the responsibility for regulating 
most therapeutic biologics, with certain exceptions (e.g., cell and 
gene therapy products and therapeutic vaccines) was transferred from 
the Office of Therapeutics Research and Review (OTRR), CBER, to the 
Office of New Drugs (OND) and the Office of Pharmaceutical Science 
(OPS), CDER. Initially, this transfer of products was effected when the 
divisions of OTRR formerly within CBER were detailed to offices within 
CDER. On October 1, 2003, those CBER offices detailed to CDER were 
incorporated into CDER's organizational structure. Throughout these 
transitions, the staff that was formerly with OTRR, CBER, maintained 
responsibility for the therapeutic biologic products.
    The two new CDER offices established for review of the therapeutic 
biologics include the OND, Office of Drug Evaluation VI (ODE VI), and 
the OPS, Office of Biotechnology Products (OBP). Within ODE VI, the 
following divisions were established: Division of Therapeutic 
Biological Oncology Products, Division of Therapeutic Biological 
Internal Medicine Products, and Division of Review Management and 
Policy. Within OBP, the following divisions were established: Division 
of Monoclonal Antibodies and Division of Therapeutic Proteins. The 
delegations of authority for CBER and CDER, which give officials in the 
Centers the legal authority needed to take substantive actions and 
perform certain functions of the Commissioner of Food and Drugs, have 
been revised to reflect these changes.

B. Products Transferred to CDER and Products Remaining in CBER

    The change in regulatory responsibility resulted in the transfer of 
applications to CDER for products belonging to the following product 
classes:
     Monoclonal antibodies for in-vivo use;
     Proteins intended for therapeutic use, including cytokines 
(e.g., interferons), enzymes (e.g., thrombolytics), and other novel 
proteins, except for those that are specifically assigned to CBER 
(e.g., vaccines and blood products). This category includes therapeutic 
proteins derived from plants, animals, or microorganisms, and 
recombinant versions of these products;
     Immunomodulators (nonvaccine and nonallergenic products 
intended to treat disease by inhibiting or modifying a preexisting 
immune response); and
     Growth factors, cytokines, and monoclonal antibodies 
intended to mobilize, stimulate, decrease or otherwise alter the 
production of hematopoietic cells in vivo.\1\
---------------------------------------------------------------------------

    \1\ Growth factors, cytokines, and monoclonal antibodies 
intended to mobilize, stimulate, decrease or otherwise alter the 
production of hematopoietic cells in vivo, for the purpose of being 
harvested for use in the production of a therapeutic cellular or 
blood product, may be regulated in combination with the therapeutic 
cellular or blood product, as appropriate. Sponsors of products that 
fit this description should contact the center jurisdiction officers 
for guidance on appropriate center assignment.
---------------------------------------------------------------------------

The following biological product classes remain at CBER:
     Cellular products, including products composed of human, 
bacterial or animal cells (such as pancreatic islet cells for 
transplantation), or from physical parts of those cells (such as whole 
cells, cell fragments, or other components intended for use as 
preventative or therapeutic vaccines);
     Allergenic extracts used for the diagnosis and treatment 
of allergic diseases and allergen patch tests;
     Antitoxins, antivenins, and venoms;
     Vaccines (products intended to induce or increase an 
antigen specific immune response for prophylactic or therapeutic 
immunization, regardless of the composition or method of manufacture);
     Blood, blood components, plasma derived products (e.g., 
albumin, immunoglobulins, clotting factors, fibrin sealants, proteinase 
inhibitors), including recombinant and transgenic versions of plasma 
derivatives (e.g., clotting factors), blood substitutes,

[[Page 14979]]

plasma volume expanders, human or animal polyclonal antibody 
preparations including radiolabeled or conjugated forms, and certain 
fibrinolytics such as plasma-derived plasmin, and red cell reagents.
    The lists above contain some combination products comprised of a 
biological product component with a device and/or drug component, 
though such products are not specifically identified. Combination 
products are assigned to a Center for review and regulation in 
accordance with the products' primary mode of action.\2\ When a 
product's primary mode of action is attributable to a type of 
biological product assigned to CDER, the product will be assigned to 
CDER. Similarly, when a product's primary mode of action is 
attributable to a type of biological product assigned to CBER, the 
product will be assigned to CBER. For further information about 
combination products, see http://www.fda.gov/oc/combination, or contact 
the Office of Combination Products at 301-827-9229, or 
combination[email protected].
---------------------------------------------------------------------------

    \2\ See section 503(g) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 353(g)).
---------------------------------------------------------------------------

II. Organizational and Mailing Address Changes

    As a result of this product consolidation and the resulting changes 
to the organizational structure of CBER and CDER, certain technical 
amendments are necessary to the regulations in title 21 of the Code of 
Federal Regulations, chapter I. These amendments include adding 
references to CDER or the CDER Director, and the CDER address 
information or updated CDER address information where appropriate. CDER 
has announced through the Internet new mailing addresses for certain 
therapeutic biological product submissions.
    We are also amending the biologics regulations in parts 600 through 
680 (21 CFR parts 600 through 680) to update the mailing address 
information including mailing codes for the various submissions to 
CBER, and are amending these regulations to place the current mailing 
addresses in a single location in part 600.
    The various CBER mailing addresses currently listed in the 
biologics regulations under parts 600 through 680, as applicable, are 
being moved to one location under new Sec.  600.2. The creation of 
Sec.  600.2 will ensure the consistency and accuracy of the regulations 
in part 600 by providing one central location to obtain CBER's mailing 
addresses and will expedite the mail flow system throughout CBER. 
Section 600.2 will provide the public with direct and easy access to 
CBER's mailing addresses for various CBER submissions. The specific 
biologics regulations will continue to identify the appropriate 
recipient and specific submission requirements for the various CBER 
submissions. Section 600.2 will include the addresses for submissions 
such as biologics license applications and the amendments and 
supplements to these applications, samples and protocols for licensed 
biological products, biological product deviation reports, adverse 
experience reports, fatality reports, Vaccine Adverse Event Reporting 
System (VAERS) reports, and other correspondence.
    The CDER addresses for some of the various submissions under parts 
600 through 680, related to the transferred biological products 
regulated by CDER, have also been included in Sec.  600.2.
    In the amendments to parts 1, 99, 201, 203, 206, 310, 312, and 314 
(21 CFR parts 1, 99, 201, 203, 206, 310, 312, and 314), the updated 
CBER mailing address and other related information will continue to be 
located directly in the applicable regulations so as to minimize the 
need for cross-referencing across different volumes of the Code of 
Federal Regulations.
    Section 610.12(e)(2)(ii) is amended to include the updated address 
for obtaining American Type Culture Collection (ATCC) strains of 
microorganisms described in that regulation and available from the 
ATCC.

III. Other Changes as a Result of the Drug and Biological Product 
Consolidation

    The revised address information for the submission of 
investigational new drug applications is included in Sec.  312.140(a). 
We are revising Sec.  312.140(b), by removing the currently listed 
products, and removing Sec.  312.140(c), biological products for human 
use which are also radioactive drugs, because these products will be 
submitted to the appropriate Center in accordance with revised Sec.  
312.140(a). As a result of the removal of current Sec.  312.140(c), we 
are redesignating current Sec.  312.140(d) as Sec.  312.140(c).
    We are removing current Sec.  314.440(b)(2), urokinase products, 
because this product is now regulated by CDER. As a result, we are 
redesignating current Sec.  314.440(b)(3) as Sec.  314.440(b)(2). We 
are also clarifying Sec.  314.440(b) by adding as paragraphs (b)(3) and 
(b)(4), two additional products that are submitted to CBER as new drug 
applications.
    We have also removed and reserved Sec.  601.2(b), radioactive 
biological products, because these products will be submitted in 
accordance with revised Sec.  601.2(a). In addition, we have removed 
any reference to Sec.  601.2(b) under Sec.  601.2.
    Finally, we have also included the appropriate CDER information 
under 21 CFR 807.90 and 822.8. This reflects the fact that authority to 
use the device authorities has already been delegated to CDER 
officials. One investigational device exemption product was transferred 
from CBER to CDER in this product consolidation initiative.
    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 this amendment to the 
regulations provides only a technical change to update information and 
addresses, and is nonsubstantive.

List of Subjects

21 CFR Part 1

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

21 CFR Part 25

    Environmental impact statements, Foreign relations, Reporting and 
recordkeeping requirements.

21 CFR Part 26

    Animal drugs, Biologics, Drugs, Exports, Imports.

21 CFR Part 99

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

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.

[[Page 14980]]

21 CFR Part 314

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

21 CFR Part 600

    Biologics, Reporting and recordkeeping requirements.

21 CFR Part 601

    Administrative practice and procedure, Biologics, Confidential 
business information.

21 CFR Part 606

    Blood, Labeling, Laboratories, Reporting and recordkeeping 
requirements.

21 CFR Part 607

    Blood.

21 CFR Part 610

    Biologics, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 640

    Blood, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 660

    Biologics, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 680

    Biologics, Blood, Reporting and recordkeeping requirements.

21 CFR Part 807

    Confidential business information, Imports, Medical devices, 
Reporting and recordkeeping requirements.

21 CFR Part 822

    Medical devices, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and Public 
Health Service Act, and under authority delegated to the Commissioner 
of Food and Drugs, 21 CFR parts 1, 25, 26, 99, 201, 203, 206, 310, 312, 
314, 600, 601, 606, 607, 610, 640, 660, 680, 807, and 822 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 paragraphs (d)(2)(i) and 
(d)(2)(ii) to read as follows:


Sec.  1.101  Notification and recordkeeping.

* * * * *
    (d) * * *
    (2) * * *
    (i) For biological products and devices regulated by the Center for 
Biologics Evaluation and Research--Division of Case Management (HFM-
610), Office of Compliance and Biologics Quality, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852-1448.
    (ii) For human drug products, biological products, and devices 
regulated by the Center for Drug Evaluation and Research--Division of 
New Drugs and Labeling Compliance (HFD-310), Center for Drug Evaluation 
and Research, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857.
* * * * *

PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS

0
3. The authority citation for 21 CFR part 25 continues to read as 
follows:

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 
4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 
1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 
1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 
Comp., p. 356-360.


Sec.  25.31  [Amended]

0
4. Section 25.31 is amended in paragraph (f) by removing the words 
``Center for Biologics Evaluation and Research'' and adding in their 
place the words ``Food and Drug Administration''.

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.


Sec.  26.4  [Amended]

0
6. Section 26.4 is amended in paragraph (b) by adding in the last 
sentence the words ``or Center for Drug Evaluation and Research'' after 
the words ``Center for Biologics Evaluation and Research''.

PART 99--DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR 
MARKETED DRUGS, BIOLOGICS, AND DEVICES

0
7. The authority citation for 21 CFR part 99 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360c, 360e, 
360aa-360aaa-6, 371, and 374; 42 U.S.C. 262.

0
8. Section 99.201 is amended by revising paragraphs (c)(1) and (c)(2) 
to read as follows:


Sec.  99.201  Manufacturer's submission to the agency.

* * * * *
    (c) * * *
    (1) For biological products and devices regulated by the Center for 
Biologics Evaluation and Research, the Advertising and Promotional 
Labeling Staff (HFM-602), Center for Biologics Evaluation and Research, 
Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448;
    (2) For human drug products, biological products, and devices 
regulated by the Center for Drug Evaluation and Research, the Division 
of Drug Marketing, Advertising, and Communications (HFD-42), Center for 
Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857; or
* * * * *

PART 201--LABELING

0
9. 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
10. Section 201.58 is amended in the first sentence by removing the zip 
code ``20587'' and adding in its place ``20857'', and by removing the 
words ``8800 Rockville Pike, Bethesda, MD 20892'' and adding in their 
place the words ``Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448''.

PART 203--PRESCRIPTION DRUG MARKETING

0
11. 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
12. Section 203.12 is amended at the end of the last sentence by adding 
the words ``or the Office of Compliance

[[Page 14981]]

(HFD-300), Center for Drug Evaluation and Research, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, depending on 
the Center responsible for regulating the product''.

0
13. Section 203.37 is amended by revising 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 and biological products regulated by the 
Center for Drug Evaluation and Research 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. Notifications 
and reports concerning prescription human biological products regulated 
by the Center for Biologics Evaluation and Research shall be made to 
the Division of Inspections and Surveillance (HFM-650), Office of 
Compliance and Biologics Quality, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852.

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

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

    Authority: 21 U.S.C. 321, 331, 351, 352, 355, 371; 42 U.S.C. 
262.

0
15. Section 206.7 is amended by revising paragraph (b)(1)(i) to read as 
follows:


Sec.  206.7  Exemptions.

* * * * *
    (b) * * *
    (1) * * *
    (i) Exemption requests for products with approved applications 
shall be made in writing to the appropriate review division in the 
Center for Drug Evaluation and Research (CDER), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857 or the Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. If FDA denies the request, the holder of the approved application 
will have 1 year after the date of an agency denial to imprint the drug 
product.
* * * * *

PART 310--NEW DRUGS

0
16. 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, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 
263b-263n.


Sec.  310.4  [Amended]

0
17. Section 310.4 is amended in paragraph (b) by removing ``601.2(b)'' 
and adding in its place ``Sec.  601.2(a)''.

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, 371; 42 
U.S.C. 262.

0
19. Section 312.140 is revised to read as follows:


Sec.  312.140  Address for correspondence.

    (a) A sponsor must send an initial IND submission to the Center for 
Drug Evaluation and Research (CDER) or to the Center for Biologics 
Evaluation and Research (CBER), depending on the Center responsible for 
regulating the product as follows:
    (1) For drug products regulated by CDER. Send the IND submission to 
the Central Document Room, Center for Drug Evaluation and Research, 
Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 
20705-1266.
    (2) For biological products regulated by CDER. Send the IND 
submission to the CDER Therapeutic Biological Products Document Room, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
12229 Wilkins Ave., Rockville, MD 20852.
    (3) For biological products regulated by CBER. Send the IND 
submission to the Document Control Center (HFM-99), Center for 
Biologics Evaluation and Research, Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448.
    (b) On receiving the IND, the responsible Center will inform the 
sponsor which one of the divisions in CDER or CBER is responsible for 
the IND. Amendments, reports, and other correspondence relating to 
matters covered by the IND should be directed to the appropriate Center 
and division. The outside wrapper of each submission shall state what 
is contained in the submission, for example, ``IND Application'', 
``Protocol Amendment'', etc.
    (c) All correspondence relating to export of an investigational 
drug under Sec.  312.110(b)(2) shall be submitted to the International 
Affairs Staff (HFY-50), Office of Health Affairs, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857.

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

0
20. 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.

0
21. Section 314.440 is amended by revising paragraph (b) to read as 
follows:


Sec.  314.440  Addresses for applications and abbreviated applications.

* * * * *
    (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 Sec.  314.110 or Sec.  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.

PART 600--BIOLOGICAL PRODUCTS: GENERAL

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

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 360i, 371, 
374; 42 U.S.C. 216, 262, 263, 263a, 264, 300aa-25.

0
23. Section 600.2 is added to subpart A to read as follows:


Sec.  600.2  Mailing addresses.

    (a) Licensed biological products regulated by the Center for 
Biologics Evaluation and Research (CBER). Unless otherwise stated in 
paragraphs (c) or (d) of this section, or as otherwise prescribed by 
FDA regulation, all submissions to CBER referenced in parts 600 through 
680 of this chapter, as applicable, must be sent to: Document Control 
Center (HFM-99), Center for Biologics Evaluation and Research, Food and 
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville,

[[Page 14982]]

MD 20852-1448. Examples of such submissions include: Biologics license 
applications (BLAs) and their amendments and supplements, adverse 
experience reports, biological product deviation reports, fatality 
reports, and other correspondence. Biological products samples must not 
be sent to this address but must be sent to the address in paragraph 
(c) of this section.
    (b) Licensed biological products regulated by the Center for Drug 
Evaluation and Research (CDER). Unless otherwise stated in paragraphs 
(b)(1), (b)(2), (b)(3), or (c) of this section, or as otherwise 
prescribed by FDA regulation, all submissions to CDER referenced in 
parts 600, 601, and 610 of this chapter, as applicable, must be sent 
to: CDER Therapeutic Biological Products Document Room, Center for Drug 
Evaluation and Research, Food and Drug Administration, 12229 Wilkins 
Ave., Rockville, MD 20852. Examples of such submissions include: BLAs 
and their amendments and supplements, and other correspondence.
    (1) Biological Product Deviation Reporting (CDER). All biological 
product deviation reports required under Sec.  600.14 must be sent to: 
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.
    (2) Postmarketing Adverse Experience Reporting (CDER). All 
postmarketing reports required under Sec.  600.80 must be sent to: 
Central Document Room, Center for Drug Evaluation and Research, Food 
and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-
1266.
    (3) Advertising and Promotional Labeling (CDER). All advertising 
and promotional labeling supplements required under Sec.  601.12(f) of 
this chapter must be sent to: Division of Drug Marketing, Advertising 
and Communication (HFD-42), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, rm. 8B45, Rockville, 
MD 20857.
    (c) Samples and Protocols for licensed biological products 
regulated by CBER or CDER. (1) Biological product samples and/or 
protocols, other than radioactive biological product samples and 
protocols, required under Sec. Sec.  600.13, 600.22, 601.15, 610.2, 
660.6, 660.36, or 660.46 of this chapter must be sent by courier 
service to: Sample Custodian (ATTN: HFM-672), Food and Drug 
Administration, Center for Biologics Evaluation and Research, Bldg: 
NLRC-B, rm. 113, 5516 Nicholson Lane, Kensington, MD 20895. The 
protocol(s) may be placed in the box used to ship the samples to CBER. 
A cover letter should not be included when submitting the protocol with 
the sample unless it contains pertinent information affecting the 
release of the lot.
    (2) Radioactive biological products required under Sec.  610.2 of 
this chapter must be sent by courier service to: Sample Custodian 
(ATTN: HFM-672), Food and Drug Administration, Center for Biologics 
Evaluation and Research, Nicholson Lane Research Center, c/o Radiation 
Safety Office, National Institutes of Health, 21 Wilson Dr., rm. 107, 
Bethesda, MD 20892-6780.
    (d) Vaccine Adverse Event Reporting System (VAERS). All VAERS 
reports as specified in Sec.  600.80(c) must be sent to: Vaccine 
Adverse Event Reporting System (VAERS), P.O. Box 1100, Rockville, MD 
20849-1100.
    (e) Address information for submissions to CBER and CDER other than 
those listed in parts 600 through 680 of this chapter are included 
directly in the applicable regulations.
    (f) Obtain updated mailing address information for biological 
products regulated by CBER at http://www.fda.gov/cber/pubinquire.htm, 
or for biological products regulated by CDER at http://www.fda.gov/cder/biologics/default.htm.


Sec.  600.3  [Amended]

0
24. Section 600.3 is amended in paragraph (gg) by removing the words 
``to the Director, Center for Biologics Evaluation and Research,''.


Sec.  600.11  [Amended]

0
25. Section 600.11 is amended in paragraph (f)(6) by adding at the end 
of the paragraph the words ``or the Director, Center for Drug 
Evaluation and Research (see mailing addresses in Sec.  600.2)''.


Sec.  600.12  [Amended]

0
26. Section 600.12 is amended in paragraph (b)(2) by adding the words 
``or the Director, Center for Drug Evaluation and Research'' after the 
words ``Director, Center for Biologics Evaluation and Research'', and 
in paragraph (b)(3) by adding the words ``or the Director, Center for 
Drug Evaluation and Research'' after the words ``Director, Center for 
Biologics Evaluation and Research''.

0
27. Section 600.13 is amended by revising the last two sentences to 
read as follows:


Sec.  600.13  Retention samples.

    * * * Samples retained as required in this section shall be in 
addition to samples of specific products required to be submitted to 
the Center for Biologics Evaluation and Research or the Center for Drug 
Evaluation and Research (see mailing addresses in Sec.  600.2). 
Exceptions may be authorized by the Director, Center for Biologics 
Evaluation and Research or the Director, Center for Drug Evaluation and 
Research, when the lot yields relatively few final containers and when 
such lots are prepared by the same method in large number and in close 
succession.

0
28. Section 600.14 is amended by revising paragraph (e) to read as 
follows:


Sec.  600.14  Reporting of biological product deviations by licensed 
manufacturers.

* * * * *
    (e) Where do I report under this section?
    (1) For biological products regulated by the Center for Biologics 
Evaluation and Research (CBER), send the completed Form FDA-3486 to the 
Director, Office of Compliance and Biologics Quality (HFM-600) (see 
mailing addresses in Sec.  600.2), or an electronic filing through 
CBER's Web site at http://www.fda.gov/cber/biodev/biodev.htm.
    (2) For biological products regulated by the Center for Drug 
Evaluation and Research (CDER), send the completed Form FDA-3486 to the 
Division of Compliance Risk Management and Surveillance (HFD-330) (see 
mailing addresses in Sec.  600.2). CDER does not currently accept 
electronic filings.
    (3) If you make a paper filing, you should identify on the envelope 
that a biological product deviation report (BPDR) is enclosed.
* * * * *


Sec.  600.22  [Amended]

0
29. Section 600.22 is amended in paragraph (e) by adding the words ``or 
the Director, Center for Drug Evaluation and Research (see mailing 
addresses in Sec.  600.2) after the words ``Director, Center for 
Biologics Evaluation and Research''.

0
30. Section 600.80 is amended by revising paragraphs (c) introductory 
text and (f)(4) to read as follows:


Sec.  600.80  Postmarketing reporting of adverse experiences.

* * * * *
    (c) Reporting requirements. The licensed manufacturer shall report 
to FDA adverse experience information, as described in this section. 
The licensed manufacturer shall submit two copies of each report 
described in this section for nonvaccine biological products to the 
Center for Biologics Evaluation and Research (HFM-210), or to the 
Center for Drug Evaluation and Research (see mailing addresses in Sec.  
600.2). Submit all vaccine adverse experience reports to: Vaccine 
Adverse Event Reporting

[[Page 14983]]

System (VAERS) (see mailing addresses in Sec.  600.2). FDA may waive 
the requirement for the second copy in appropriate instances.
* * * * *
    (f) * * *
    (4) Copies of the reporting form designated by FDA (FDA-3500A) for 
nonvaccine biological products may be obtained from http://www.fda.gov/medwatch/getforms.htm. Additional supplies of the form may be obtained 
from the Consolidated Forms and Publications Distribution Center, 3222 
Hubbard Rd., Landover, MD 20785. Supplies of the VAERS form may be 
obtained from VAERS by calling 1-800-822-7967.
* * * * *

0
31. Section 600.81 is amended by revising the first sentence to read as 
follows:


Sec.  600.81  Distribution reports.

    The licensed manufacturer shall submit to the Center for Biologics 
Evaluation and Research or the Center for Drug Evaluation and Research 
(see mailing addresses in Sec.  600.2), information about the quantity 
of the product distributed under the biologics license, including the 
quantity distributed to distributors. * * *

PART 601--LICENSING

0
32. The authority citation for 21 CFR part 601 continues to read as 
follows:

    Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 
355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 
216, 241, 262, 263, 264; sec. 122, Pub. L. 105-115, 111 Stat. 2322 
(21 U.S.C. 355 note).

0
33. Section 601.2 is amended by revising the first and fourth sentences 
and removing the sixth sentence of paragraph (a), by removing and 
reserving paragraph (b), and by revising paragraph (c)(2) to read as 
follows:


Sec.  601.2  Applications for biologics licenses; procedures for 
filing.

    (a) General. To obtain a biologics license under section 351 of the 
Public Health Service Act for any biological product, the manufacturer 
shall submit an application to the Director, Center for Biologics 
Evaluation and Research or the Director, Center for Drug Evaluation and 
Research (see mailing addresses in Sec.  600.2 of this chapter), on 
forms prescribed for such purposes, and shall submit data derived from 
nonclinical laboratory and clinical studies which demonstrate that the 
manufactured product meets prescribed requirements of safety, purity, 
and potency; with respect to each nonclinical laboratory study, either 
a statement that the study was conducted in compliance with the 
requirements set forth in part 58 of this chapter, or, if the study was 
not conducted in compliance with such regulations, a brief statement of 
the reason for the noncompliance; statements regarding each clinical 
investigation involving human subjects contained in the application, 
that it either was conducted in compliance with the requirements for 
institutional review set forth in part 56 of this chapter; or was not 
subject to such requirements in accordance with Sec.  56.104 or Sec.  
56.105, and was conducted in compliance with requirements for informed 
consent set forth in part 50 of this chapter. * * * An application for 
a biologics license shall not be considered as filed until all 
pertinent information and data have been received by the Food and Drug 
Administration. * * *
    (b) [Reserved]
    (c) * * *
    (2) To the extent that the requirements in this paragraph (c) 
conflict with other requirements in this subchapter, this paragraph (c) 
shall supersede other requirements.
* * * * *


Sec.  601.4  [Amended]

0
34. Section 601.4 is amended in the first sentence of paragraph (a) by 
adding the words ``or the Director, Center for Drug Evaluation and 
Research'' after the words ``Director, Center for Biologics Evaluation 
and Research''.

0
35. Section 601.6 is amended by revising paragraph (a)(2) to read as 
follows:


Sec.  601.6  Suspension of license.

    (a) * * *
    (2) Furnish to the Center for Biologics Evaluation and Research or 
the Center for Drug Evaluation and Research, complete records of such 
deliveries and notice of suspension.
* * * * *


Sec.  601.9  [Amended]

0
36. Section 601.9 is amended in paragraph (a) by adding at the end of 
the paragraph the words ``or the Director, Center for Drug Evaluation 
and Research''.

0
37. Section 601.12 is amended by revising the first sentence of 
paragraph (a)(1), by revising the second sentence of paragraph (d)(1), 
and by revising paragraph (f)(4) to read as follows:


Sec.  601.12  Changes to an approved application.

    (a)(1) General. As provided by this section, an applicant must 
inform the Food and Drug Administration (FDA) (see mailing addresses in 
Sec.  600.2 of this chapter) about each change in the product, 
production process, quality controls, equipment, facilities, 
responsible personnel, or labeling established in the approved license 
application(s). * * *
* * * * *
    (d) * * *
    (1) * * * The Director, Center for Biologics Evaluation and 
Research or the Director, Center for Drug Evaluation and Research, may 
approve a written request for an alternative date to combine annual 
reports for multiple approved applications into a single annual report 
submission.
* * * * *
    (f) * * *
    (4) Advertisements and promotional labeling. Advertisements and 
promotional labeling shall be submitted to the Center for Biologics 
Evaluation and Research or Center for Drug Evaluation and Research in 
accordance with the requirements set forth in Sec.  314.81(b)(3)(i) of 
this chapter, except that Form FDA-2567 (Transmittal of Labels and 
Circulars) or an equivalent form shall be used.
* * * * *

0
38. Section 601.15 is revised to read as follows:


Sec.  601.15  Foreign establishments and products: samples for each 
importation.

    Random samples of each importation, obtained by the District 
Director of Customs and forwarded to the Director, Center for Biologics 
Evaluation and Research or the Director, Center for Drug Evaluation and 
Research (see mailing addresses in Sec.  600.2 of this chapter) must be 
at least two final containers of each lot of product. A copy of the 
associated documents which describe and identify the shipment must 
accompany the shipment for forwarding with the samples to the Director, 
Center for Biologics Evaluation and Research or the Director, Center 
for Drug Evaluation and Research (see mailing addresses in Sec.  
600.2). For shipments of 20 or less final containers, samples need not 
be forwarded, provided a copy of an official release from the Center 
for Biologics Evaluation and Research or Center for Drug Evaluation and 
Research accompanies each shipment.


Sec.  601.20  [Amended]

0
39. Section 601.20 is amended in paragraph (c) by adding the words ``or 
the Director, Center for Drug Evaluation and Research'' after the words 
``Director, Center for Biologics Evaluation and Research''.

[[Page 14984]]


0
40. Section 601.28 is amended by revising the introductory paragraph to 
read as follows:


Sec.  601.28  Annual reports of postmarketing pediatric studies.

    Sponsors of licensed biological products shall submit the following 
information each year within 60 days of the anniversary date of 
approval of each product under the license to the Director, Center for 
Biologics Evaluation and Research or the Director, Center for Drug 
Evaluation and Research (see mailing addresses in Sec.  600.2 of this 
chapter):
* * * * *


Sec.  601.29  [Amended]

0
41. Section 601.29 is amended in paragraph (b) by removing the words 
``, 1401 Rockville Pike, Rockville, MD 20852-1448'' and adding in their 
place ``(see mailing addresses in Sec.  600.2 of this chapter)''.


Sec.  601.43  [Amended]

0
42. Section 601.43 is amended in paragraph (b) by adding in the first 
sentence the words ``or the Director of the Center for Drug Evaluation 
and Research'' after the words ``Director of the Center for Biologics 
Evaluation and Research''.


Sec.  601.51  [Amended]

0
43. Section 601.51 is amended in last sentence of paragraph (b) by 
removing the words ``Director of the Center for Biologics Evaluation 
and Research'' and adding in their place the words ``Food and Drug 
Administration''.

0
44. Section 601.70 is amended by revising paragraph (d) to read as 
follows:


Sec.  601.70  Annual progress reports of postmarketing studies.

* * * * *
    (d) Where to report. Submit two copies of the annual progress 
report of postmarketing studies to the Center for Biologics Evaluation 
and Research or Center for Drug Evaluation and Research (see mailing 
addresses in Sec.  600.2 of this chapter).
* * * * *

0
45. Section 601.92 is amended by revising the first sentence of 
paragraph (b) to read as follows:


Sec.  601.92  Withdrawal procedures.

* * * * *
    (b) Notice of opportunity for a hearing. The Director of the Center 
for Biologics Evaluation and Research or the Director of the Center for 
Drug Evaluation and Research will give the applicant notice of an 
opportunity for a hearing on the proposal to withdraw the approval of 
an application approved under this subpart. * * *
* * * * *

PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD 
AND COMPONENTS

0
46. The authority citation for 21 CFR part 606 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360j, 371, 
374; 42 U.S.C. 216, 262, 263a, 264.


Sec.  606.121  [Amended]

0
47. Section 606.121 is amended in the introductory text of paragraph 
(d), and paragraphs (d)(4) and (d)(5) by removing the mail code ``(HFB-
1)''.


Sec.  606.171  [Amended]

0
48. Section 606.171 is amended in the introductory text in paragraph 
(e) by removing the words ``, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448'' and adding in their place ``(see mailing 
addresses in Sec.  600.2 of this chapter)''.

PART 607--ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR 
MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS

0
49. The authority citation for 21 CFR part 607 continues to read as 
follows:

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


Sec.  607.7  [Amended]

0
50. Section 607.7 is amended in paragraphs (b) and (c) by removing the 
words ``, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448'' 
and adding in their place ``(see mailing addresses in Sec.  600.2 of 
this chapter)''.


Sec.  607.22  [Amended]

0
51. Section 607.22 is amended in the first sentence in paragraph (a) by 
removing the words ``1401 Rockville Pike, suite 200N, Rockville, MD 
20852-1448'' and adding in their place ``(see mailing addresses in 
Sec.  600.2 of this chapter)''.


Sec.  607.37  [Amended]

0
52. Section 607.37 is amended in the first sentence of paragraph (a), 
and in paragraph (b) by removing the words ``, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448'' and adding in their place ``(see 
mailing addresses in Sec.  600.2 of this chapter)''.

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

0
53. The authority citation for 21 CFR part 610 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 
360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 
264.

0
54. Section 610.2 is amended by revising the paragaph heading and first 
sentence of paragraph (a) and by revising the heading and paragraph (b) 
to read as follows:


Sec.  610.2  Requests for samples and protocols; official release.

    (a) Licensed biological products regulated by CBER. Samples of any 
lot of any licensed product together with the protocols showing results 
of applicable tests, may at any time be required to be sent to the 
Director, Center for Biologics Evaluation and Research (see mailing 
addresses in Sec.  600.2 of this chapter). * * *
    (b) Licensed biological products regulated by CDER. Samples of any 
lot of any licensed product together with the protocols showing results 
of applicable tests, may at any time be required to be sent to the 
Director, Center for Drug Evaluation and Research (see mailing 
addresses in Sec.  600.2) for official release. Upon notification by 
the Director, Center for Drug Evaluation and Research, a manufacturer 
shall not distribute a lot of a biological product until the lot is 
released by the Director, Center for Drug Evaluation and Research: 
Provided, That the Director, Center for Drug Evaluation and Research 
shall not issue such notification except when deemed necessary for the 
safety, purity, or potency of the product.


Sec.  610.9  [Amended]

0
55. Section 610.9 is amended in paragraph (b) by removing the words ``, 
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-
1448'' and adding in their place the words ``or the Director, Center 
for Drug Evaluation and Research.''

0
56. Section 610.11 is amended by revising the first sentence in 
paragraphs (c)(2) and (c)(3), and by revising the first and last 
sentences of paragraph (g)(2) to read as follows:


Sec.  610.11  General safety.

* * * * *
    (c) * * *
    (2) Freeze-dried product for which the volume of reconstitution is 
not indicated on the label. The route of administration, test dose, and 
diluent shall be as approved in accordance with Sec.  610.9. * * *

[[Page 14985]]

    (3) Nonliquid products other than freeze-dried product. The route 
of administration, test dose, and diluent shall be as in accordance 
with Sec.  610.9. * * *
    (g)* * *
    (2) For products other than those identified in paragraph (g)(1) of 
this section, a manufacturer may request from the Director, Center for 
Biologics Evaluation and Research or the Director, Center for Drug 
Evaluation and Research (see mailing addresses in Sec.  600.2 of this 
chapter), an exemption from the general safety test. * * * The 
Director, Center for Biologics Evaluation and Research or the Director, 
Center for Drug Evaluation and Research, upon finding that the 
manufacturer's request justifies an exemption, may exempt the product 
from the general safety test subject to any condition necessary to 
assure the safety, purity, and potency of the product.

0
57. Section 610.12 is amended by revising the last sentence of 
paragraph (e)(2)(i), by revising the first sentence of the text 
appearing after the table in paragraph (e)(2)(ii), and by revising 
paragraph (g)(4)(ii) to read as follows:


Sec.  610.12  Sterility.

* * * * *
    (e) * * *
    (2) * * *
    (i)* * * When using a single batch of dehydrated culture medium, a 
manufacturer need not perform growth-promoting tests on each lot of 
prepared liquid medium, provided that a validation program exists for 
autoclaves used to sterilize the culture medium, and the manufacturer 
has received approval for this practice from the Director, Center for 
Biologics Evaluation and Research or the Director, Center for Drug 
Evaluation and Research.
    (ii) * * *
    ATCC strains of microorganisms described in this section are 
available from the American Type Culture Collection, 10801 University 
Blvd., Manassas, VA 20110. * * *
* * * * *
    (g)* * *
    (4)* * *
    (ii) Where a manufacturer submits data which the Director, Center 
for Biologics Evaluation and Research or the Director, Center for Drug 
Evaluation and Research, finds adequate to establish that the mode of 
administration, the method of preparation, or the special nature of the 
product precludes or does not require a sterility test or that the 
sterility of the lot is not necessary to assure the safety, purity, and 
potency of the product, the Director may exempt a product from the 
sterility requirements of this section subject to any conditions 
necessary to assure the safety, purity, and potency of the product.
* * * * *


Sec.  610.13  [Amended]

0
58. Section 610.13 is amended in the last sentence of paragraph (a)(1) 
by adding the words ``or the Director, Center for Drug Evaluation and 
Research'' after the words ``Director, Center for Biologics Evaluation 
and Research''.


Sec.  610.15  [Amended]

0
59. Section 610.15 is amended in paragraph (a)(3) by adding at the end 
of the last sentence the words ``or the Director, Center for Drug 
Evaluation and Research (see mailing addresses in Sec.  600.2 of this 
chapter)''.


Sec.  610.18  [Amended]

0
60. Section 610.18 is amended in paragraph (c)(2) by adding at the end 
of the last sentence the words ``or the Director, Center for Drug 
Evaluation and Research''.


Sec.  610.53  [Amended]

0
61. Section 610.53 is amended in paragraph (d) by adding at the end of 
the last sentence the words ``or the Director of the Center for Drug 
Evaluation and Research''.

PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS

0
62. The authority citation for 21 CFR part 640 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 
U.S.C. 216, 262, 263, 263a, 264.


Sec.  640.55  [Amended]

0
63. Section 640.55 is amended by removing the words ``Food and Drug 
Administration,'' and adding in their place ``(HFM-407) (see mailing 
addresses in Sec.  600.2 of this chapter)''.

PART 660--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR 
LABORATORY TESTS

0
64. The authority citation for 21 CFR part 660 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 
360d, 360h, 360i, 371, 372; 42 U.S.C. 216, 262, 263, 263a, 264.


Sec.  660.3  [Amended]

0
65. Section 660.3 is amended by adding the words ``(HFM-407) (see 
mailing addresses in Sec.  600.2 of this chapter)'' after the words 
``Center for Biologics Evaluation and Research''.


Sec.  660.6  [Amended]

0
66. Section 660.6 is amended in paragraph (a)(2) by removing the words 
``(HFB-1), 8800 Rockville Pike, Bethesda, MD 20892'' and adding in 
their place ``(see mailing addresses in Sec.  600.2 of this chapter)''.


Sec.  660.21  [Amended]

0
67. Section 660.21 is amended in paragraph (b) by removing the words 
``(HFN-830), Food and Drug Administration, 8800 Rockville Pike, 
Bethesda, MD 20892''.


Sec.  660.22  [Amended]

0
68. Section 660.22 is amended in paragraph (b) by removing the words 
``(HFN-890), Food and Drug Administration, 8800 Rockville Pike, 
Bethesda, MD 20892'' and adding in their place ``(HFM-407) (see mailing 
addresses in Sec.  600.2 of this chapter)''.


Sec.  660.25  [Amended]

0
69. Section 660.25 is amended in the introductory paragraph and 
paragraph (a) introductory text by removing the words ``(HFN-830), Food 
and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892''.


Sec.  660.26  [Amended]

0
70. Section 660.26 is amended by removing the words ``(HFN-830), Food 
and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892''.


Sec.  660.28  [Amended]

0
71. Section 660.28 is amended in the first sentence of paragraph (a)(1) 
by removing the words ``(HFN-830), Food and Drug Administration, 8800 
Rockville Pike, Bethesda, MD 20892''.


Sec.  660.36  [Amended]

0
72. Section 660.36 is amended in paragraph (a) by removing the words 
``Office of Biological Product Review Sample Custodian (ATTN: HFB-215), 
Bldg. 29A, Rm. 1C02, Food and Drug Administration, 8800 Rockville Pike, 
Bethesda, MD 20892'' and adding in their place the words ``Center for 
Biologics Evaluation and Research Sample Custodian (ATTN: HFM-672) (see 
mailing addresses in Sec.  600.2 of this chapter)''.


Sec.  660.46  [Amended]

0
73. Section 660.46 is amended in paragraph (a)(2) introductory text by 
removing the words ``(HFB-1), 8800 Rockville Pike, Bethesda, MD 20892'' 
and adding in their place ``(see mailing addresses in Sec.  600.2 of 
this chapter)''.

[[Page 14986]]

Sec.  660.52  [Amended]

0
74. Section 660.52 is amended by removing the words ``(HFB-221), Food 
and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892'' and 
adding in their place ``(HFM-407) (see mailing addresses in Sec.  600.2 
of this chapter)''.


Sec.  660.53  [Amended]

0
75. Section 660.53 is amended by removing the words ``(HFB-1), Food and 
Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892''.


Sec.  660.54  [Amended]

0
76. Section 660.54 is amended in the introductory paragraph by removing 
the words ``(HFB-1), Food and Drug Administration, 8800 Rockville Pike, 
Bethesda, MD 20892''.


Sec.  660.55  [Amended]

0
77. Section 660.55 is amended in the first sentence of paragraph (a)(3) 
by removing the mail code ``(HFB-1)''.

PART 680--ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS

0
78. The authority citation for 21 CFR part 680 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 
U.S.C. 216, 262, 263, 263a, 264.


Sec.  680.1  [Amended]

0
79. Section 680.1 is amended in the last sentence of paragraph 
(b)(2)(iii), in paragraph (b)(3)(iv), and in the first sentence of 
paragraph (c) by removing the mail code ``(HFB-1)'' and adding in its 
place ``(see mailing addresses in Sec.  600.2)'', and in paragraph 
(d)(1) by removing the mail code ``(HFB-1)''.

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR 
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

0
80. The authority citation for 21 CFR part 807 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 
360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.

0
81. Section 807.90 is amended by revising the first sentence of 
paragraph (a)(2) to read as follows:


Sec.  807.90  Format of a premarket notification submission.

    (a)* * *
    (2) For devices regulated by the Center for Biologics Evaluation 
and Research, be addressed to the Document Control Center (HFM-99), 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448; or for devices regulated by the Center for Drug Evaluation and 
Research, be addressed to the Central Document Room, Center for Drug 
Evaluation and Research, Food and Drug Administration, 5901-B Ammendale 
Rd., Beltsville, MD 20705-1266. * * *
* * * * *

PART 822--POSTMARKET SURVEILLANCE

0
82. The authority citation for 21 CFR part 822 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.

0
83. Section 822.8 is amended by revising the second and third sentences 
to read as follows:


Sec.  822.8  When, where, and how must I submit my postmarket 
surveillance plan?

    * * * For devices regulated by the Center for Biologics Evaluation 
and Research, send three copies of your submission to the Document 
Control Center (HFM-99), Center for Biologics Evaluation and Research, 
Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448. For devices regulated by the Center for Drug 
Evaluation and Research, send three copies of your submission to the 
Central Document Room, Center for Drug Evaluation and Research, Food 
and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-
1266. * * *

    Dated: March 15, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-5780 Filed 3-23-05; 8:45 am]
BILLING CODE 4160-01-S