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