80 FR 18087 - Food and Drug Administration Regulations; Change of Addresses; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 64 (April 3, 2015)

The Food and Drug Administration (FDA) is amending its regulations to update address information for the Center for Biologics Evaluation and Research (CBER) as a result of the recent relocation of CBER offices and laboratories to the FDA White Oak campus in Silver Spring, MD, as well as make other related technical revisions. These changes are being made to ensure the accuracy of the Agency's regulations.

[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)]
[Rules and Regulations]
[Pages 18087-18095]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07268]



[[Page 18087]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 26, 99, 201, 203, 206, 207, 310, 312, 314, 600, 
601, 606, 607, 610, 660, 680, 801, 807, 812, 814, 822, and 1271

[Docket No. FDA-2015-N-0011]


Food and Drug Administration Regulations; Change of Addresses; 
Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to update address information for the Center for Biologics 
Evaluation and Research (CBER) as a result of the recent relocation of 
CBER offices and laboratories to the FDA White Oak campus in Silver 
Spring, MD, as well as make other related technical revisions. These 
changes are being made to ensure the accuracy of the Agency's 
regulations.

DATES: This rule is effective April 3, 2015.

FOR FURTHER INFORMATION CONTACT: John Reilly, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations in parts 1, 
26, 99, 201, 203, 206, 207, 310, 312, 314, 600, 601, 606, 607, 610, 
660, 680, 801, 807, 812, 814, 822, and 1271 (21 CFR parts 1, 26, 99, 
201, 203, 206, 207, 310, 312, 314, 600, 601, 606, 607, 610, 660, 680, 
801, 807, 812, 814, 822, and 1271) to reflect the following changes: 
(1) The relocation of CBER offices and laboratories from various 
Rockville and Bethesda, MD, locations to the FDA White Oak campus in 
Silver Spring, MD; (2) the change of address of CBER's Document Control 
Center; (3) updating the names of certain CBER organizational units 
referenced in the regulations; (4) revising certain cross-references to 
be more specific and thereby facilitate locating the appropriate 
mailing addresses for submissions, requests, and other correspondence 
relating to biological products regulated by CBER and the Center for 
Drug Evaluation and Research (CDER); and (5) making other minor changes 
to ensure accuracy. The updated addresses include locations to which 
applicants must submit information related to applications or products 
regulated by CBER or from which the public can request information. 
Where appropriate, CBER Web addresses for obtaining or submitting forms 
and other information are added or updated, and outdated addresses are 
removed. In certain instances, mail previously addressed to specific 
CBER offices should now be addressed to the CBER Document Control 
Center.
    The technical amendments, reflected in the regulatory text of this 
final rule, are as follows:
     In Sec.  1.101(d)(2)(i), the CBER unit and address for 
submitting notifications regarding CBER-regulated products exported 
under section 802 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 382) are updated to the CBER Document Control Center on the 
White Oak campus.
     In Appendix E to subpart A of part 26, the contact 
information provided for CBER, including its address, telephone, and 
fax numbers to be used in the two-way alert system established in 
accordance with the 1998 ``Agreement on Mutual Recognition Between the 
United States of America and the European Community,'' is updated to 
reflect CBER's move to the White Oak campus.
     In Sec.  99.201(c)(1), the CBER unit and address to send a 
submission and certification statement, or to send an application for 
exemption relating to the dissemination of information on an 
unapproved/new use regarding a biological product or device is updated 
to the CBER Document Control Center on the White Oak campus.
     In Sec.  201.25(d)(2), the CBER unit and address for 
submitting a request for exemption from the bar code label requirement 
for biological products regulated by CBER are updated to the CBER 
Document Control Center on the White Oak campus. Several other minor 
changes are made to this provision for purposes of clarity and 
correctness in referring to products regulated by CBER or CDER.
     In Sec.  201.58, the CBER unit and address for submitting 
a request for waiver from certain labeling requirements are updated to 
the CBER Document Control Center on the White Oak campus.
     In Sec.  203.12, the CBER unit and address for submitting 
an appeal from an adverse decision relating to the reimportation of 
biological products regulated by CBER are updated to the CBER Document 
Control Center on the White Oak campus. Several other minor changes in 
terminology also are made to this provision for purposes of accuracy 
and consistency when referring to products regulated by CBER or CDER.
     In Sec.  203.37(e), the CBER unit and address for 
submitting information in notifications and reports involving human 
prescription biological products regulated by CBER are updated to the 
CBER Document Control Center on the White Oak campus. Several other 
minor changes in terminology also are made to this provision for 
purposes of accuracy and consistency when referring to products 
regulated by CBER or CDER.
     In Sec.  203.70(b)(2), the CBER unit and address to apply 
for a reward when providing information leading to a criminal 
proceeding or conviction related to the sale, purchase, or trade of a 
drug sample are updated to the CBER Document Control Center on the 
White Oak campus.
     In Sec.  206.7(b)(1)(i), the CBER unit and address for 
requesting an exemption from imprinting requirements involving human 
drug products in solid oral dosage form are updated to the CBER 
Document Control Center on the White Oak campus.
     In Sec.  207.7(a), the CBER unit and address for 
submitting blood establishment registration and product listing 
information are updated to the CBER Document Control Center on the 
White Oak campus.
     In Sec.  310.503(f)(3), the CBER unit and address for 
submitting an investigational new drug (IND) application or an 
application for a biologics license under section 351 of the Public 
Health Service Act with regard to certain radioactive drugs considered 
biologics are updated to the CBER Document Control Center on the White 
Oak campus.
     In Sec.  312.140(a)(3), the address for submitting an IND 
application involving biological products regulated by CBER is updated 
to the White Oak campus.
     In Sec.  312.145(b), the CBER unit and address from which 
to request a list of CBER guidances are updated to the Office of 
Communication, Outreach and Development and the White Oak campus.
     In Sec.  312.310(d)(1), the CBER local telephone number 
for requesting emergency expanded access use of investigational 
biological drug products regulated by CBER is updated.
     In Sec.  314.440(b), the CBER addresses for submitting new 
drug applications and other correspondence involving certain drug 
products used in the collection, processing, or storage of

[[Page 18088]]

blood components, as well as the address for requesting an opportunity 
for a hearing, are updated to the White Oak campus.
     In Sec.  600.2(a), the CBER Document Control Center 
address for regulatory submissions and other correspondence pertaining 
to licensed biological products regulated by CBER is updated to the 
White Oak campus.
     In Sec.  600.2(c)(1), the CBER Sample Custodian address 
for submitting samples and protocols of licensed biological products 
regulated by CBER or CDER is updated to the White Oak campus.
     In Sec.  600.2(c)(2), the unit and address for submitting 
samples and protocols of radioactive biological products are updated to 
the White Oak Radiation Safety Program and the White Oak campus.
     In Sec.  600.11(f)(6), the cross-reference ``Sec.  600.2'' 
is changed to ``Sec.  600.2(a) or (b)'' to provide a more specific 
citation to the appropriate CBER or CDER address to use when notifying 
FDA of certain infectious animal diseases.
     In Sec.  600.14(e)(1), the CBER unit and address for 
reporting biological product deviations for products regulated by CBER 
are updated to the CBER Document Control Center on the White Oak 
campus. The specific CBER Web address for submitting such reports 
electronically is removed, and a more general reference for submitting 
such reports electronically is added in its place.
     In Sec.  600.22(e), the cross-reference ``Sec.  600.2'' is 
changed to ``Sec.  600.2(c)'' to provide a more specific citation to 
the appropriate CBER or CDER address to use when submitting product or 
ingredient samples from an inspection of a licensed establishment.
     In Sec.  601.2(a), the cross-reference ``Sec.  600.2'' is 
changed to ``Sec.  600.2(a) or (b)'' to provide a more specific 
citation to the appropriate CBER or CDER address to use when submitting 
an application for a biologics license.
     In Sec.  601.12(f)(4), the reference to Form FDA 2567 
(Transmittal of Labels and Circulars) is removed because the form is no 
longer used.
     In Sec.  601.15, the cross-reference ``Sec.  600.2'' is 
changed to ``Sec.  600.2(c)'' to provide a more specific citation to 
the appropriate address to use when submitting samples of imported 
licensed biological products regulated by CBER or CDER.
     In Sec.  601.28, the cross-reference ``Sec.  600.2'' is 
changed to ``Sec.  600.2(a) or (b)'' to provide a more specific 
citation to the appropriate CBER or CDER address to use when submitting 
postmarketing pediatric studies with regard to licensed biological 
products.
     In Sec.  601.29(b), the CBER unit and address from which 
to request a list of CBER guidances are updated to the White Oak 
campus.
     In Sec.  601.70(d), the cross-reference ``Sec.  600.2'' is 
changed to ``Sec.  600.2(a) or (b)'' to provide a more specific 
citation to the appropriate CBER or CDER address to use when submitting 
annual progress reports of postmarketing studies.
     In Sec.  606.170(b), the cross-reference ``Sec.  600.2'' 
is changed to ``Sec.  600.2(a)'' to clarify the need to use the updated 
CBER Document Control Center address when submitting a written report 
involving a fatal adverse reaction relating to blood collection or 
transfusion.
     In Sec.  606.171(e), the CBER unit and address for 
reporting blood and blood component product deviations are updated to 
the CBER Document Control Center on the White Oak Campus. The specific 
CBER Web address for submitting such reports electronically is removed, 
and a more general reference for submitting such reports electronically 
is added in its place. Other editorial changes have been made to 
improve the provision's clarity without changing its meaning.
     In Sec.  607.7(b) and (c), the cross-reference ``Sec.  
600.2'' is changed to ``Sec.  600.2(a)'' and the reference to mail code 
``(HFM-375)'' is removed to clarify using the updated CBER Document 
Control Center address in Sec.  600.2(a) when requesting and submitting 
registration and product listing information with regard to the 
manufacture of blood products.
     In Sec.  607.22(a), the cross-reference ``Sec.  600.2'' is 
changed to ``Sec.  600.2(a)'' and the reference to mail code ``(HFM-
375)'' is removed to clarify using the updated CBER Document Control 
Center address in Sec.  600.2(a) when requesting and submitting 
registration and product listing information involving the manufacture 
of blood products on Form FDA 2830. Reference to the ``Department of 
Health and Human Services'' as part of the address has been removed.
     Section 607.37(a) is updated to reflect that registrant 
and product list information filed on Form FDA 2830 for establishments 
manufacturing blood products, previously made available through public 
inspection at CBER offices, now is accessible by using CBER's Web site 
or by visiting FDA's Division of Dockets Management. In Sec.  
607.37(b), the name of the CBER unit and address for requesting other 
information regarding blood establishment registrations and blood 
product listings are updated to the Office of Communication, Outreach 
and Development and the White Oak campus.
     In Sec.  610.2(a) and (b), the cross-reference ``Sec.  
600.2'' is changed to ``Sec.  600.2(c)'' to provide a more specific 
citation to the appropriate address to use when submitting samples and 
protocols of licensed biological products.
     In Sec.  610.11(g)(2), the cross-reference ``Sec.  600.2'' 
is changed to ``Sec.  600.2(a) or (b)'' to provide a more specific 
citation to the appropriate CBER or CDER address to use when submitting 
a request for an exemption from the general safety test requirement for 
licensed biological products.
     In Sec.  610.15(a)(3), the cross-reference ``Sec.  600.2'' 
is changed to ``Sec.  600.2(a) or (b)'' to provide a more specific 
citation to the appropriate CBER or CDER address to use when submitting 
data regarding the amount of aluminum used in individual doses of a 
biological product.
     In Sec.  660.3, the CBER unit and address for obtaining a 
Reference Hepatitis B Surface Antigen Panel have been updated to CBER 
Reagents and Standards Shipping and the White Oak campus.
     In Sec.  660.6(a)(2), the cross-reference ``Sec.  600.2'' 
is changed to ``Sec.  600.2(c)'' to provide a more specific citation to 
the appropriate address to use when submitting product samples and 
protocols involving Antibody to Hepatitis B Surface Antigen. Also, a 
misspelling of the word ``Official'' in the heading in Sec.  660.6(c) 
is corrected.
     In Sec.  660.22(b), the CBER unit and address for 
obtaining reference preparations for Reference Blood Grouping Reagents 
have been updated to CBER Reagents and Standards Shipping and the White 
Oak campus.
     In Sec.  660.36, the cross-reference to Sec.  600.2(c) is 
added to Sec.  660.36(a) and (c), and the cross-reference to Sec.  
600.2(a) is added to Sec.  660.36(b), to provide further specificity as 
to the appropriate address to use when submitting product samples and 
protocols relating to Reagent Red Blood Cells.
     In Sec.  660.46(a)(2), the cross-reference ``Sec.  600.2'' 
is changed to ``Sec.  600.2(c)'' to provide a more specific citation to 
the appropriate address to use when submitting product samples and 
protocols relating to Hepatitis B Surface Antigen.
     In Sec.  660.52, the CBER unit and address for obtaining 
reference preparations for Reference Anti-Human Globulin are updated to 
CBER Reagents

[[Page 18089]]

and Standards Shipping and the White Oak campus.
     In Sec.  680.1(b)(2)(iii), (b)(3)(iv), and (c), the cross-
reference ``Sec.  600.2'' is changed to ``Sec.  600.2(a) of this 
chapter'' to clarify using the updated CBER Document Control Center 
address when submitting the requested source material information 
regarding allergenic products.
     In Sec.  801.55(b)(1), the CBER unit and address for 
requesting an exception or alternative to a unique device identifier 
for devices regulated by CBER are updated to the CBER Document Control 
Center on the White Oak campus.
     In Sec.  807.90(a)(2), the address for submitting a 
premarket notification for devices regulated by CBER is updated to the 
White Oak campus; the specific CBER Web address for obtaining 
information about devices regulated by CBER is removed, and a more 
general reference for obtaining this information on the CBER's Web site 
is added in its place.
     In Sec.  812.19(a)(2), the address for sending 
correspondence in connection with investigational device exemptions 
(IDEs) involving devices regulated by CBER is updated to the White Oak 
campus.
     In Sec.  814.20(h)(2), the address for submitting a 
premarket approval application (PMA), a PMA amendment, a PMA 
supplement, or correspondence involving a PMA for devices regulated by 
CBER is updated to the White Oak campus.
     In Sec.  814.104(d)(2), the address for submitting an 
original PMA seeking a humanitarian device exemption (HDE), or related 
amendments or supplements, or other correspondence relating to an HDE 
for devices regulated by CBER is updated to the White Oak campus.
     In Sec.  822.8, the address for submitting a postmarket 
surveillance plan for devices regulated by CBER is updated to the White 
Oak campus.
     The address for submitting a reclassification petition for 
devices regulated by CBER in Sec.  860.123(b)(1) was updated to the 
White Oak campus in a previous FDA document published in the Federal 
Register on December 24, 2014 (79 FR 77387).
     In Sec.  1271.22(b), the CBER address and local telephone 
number for requesting Form FDA 3356 involving establishment 
registration and listing for human cells, tissues, and cellular and 
tissue-based products (HCT/Ps) are updated to the Document Control 
Center on the White Oak campus. In Sec.  1271.22(c)(1), the CBER unit 
and address for submitting Form FDA 3356 are updated to the CBER 
Document Control Center on the White Oak campus. And in Sec.  
1271.22(c)(2), the specific CBER Web address for submitting Form FDA 
3356 electronically is removed, and a more general reference for 
submitting this form electronically is added in its place.
     Section 1271.37(a) is updated to reflect that registrant 
and product list information filed on Form FDA 3356 for HCT/Ps, 
previously made available for public inspection at CBER offices, can 
now be accessed through CBER's Web site or by visiting FDA's Division 
of Dockets Management. In Sec.  1271.37(b), the name of the CBER unit 
and address for requesting other information regarding HCT/P 
establishment registrations and HCT/P listings are updated to the 
Office of Communication, Outreach and Development and the White Oak 
campus.
     In Sec.  1271.350(a)(5), the CBER unit and address for 
submitting adverse reaction reports involving an HCT/P have been 
updated to the CBER Document Control Center on the White Oak campus. In 
Sec.  1271.350(b)(3), the address for obtaining and submitting Form FDA 
3486 by mail has been updated to the CBER Document Control Center on 
the White Oak campus. The specific CBER Web addresses for obtaining and 
submitting the form electronically have been replaced by a more general 
reference to using CBER's electronic Web-based application.
    Publication of this document constitutes final action of these 
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has 
determined that notice and public comment are unnecessary because this 
amendment to the regulations provides only technical changes to update 
addresses and other information, and is nonsubstantive.

List of Subjects

21 CFR Part 1

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

21 CFR Part 26

    Animal drugs, Biologics, Drugs, Exports, Imports.

21 CFR Part 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 207

    Drugs, Reporting and recordkeeping requirements.

21 CFR Part 310

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

21 CFR Part 312

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

21 CFR Part 314

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

21 CFR Part 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 Parts 610 and 660

    Biologics, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 680

    Biologics, Blood, Reporting and recordkeeping requirements.

21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping 
requirements.

21 CFR Part 807

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

21 CFR Part 812

    Health records, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

[[Page 18090]]

21 CFR Part 814

    Administrative practice and procedure, Confidential business 
information, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

21 CFR Part 822

    Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 1271

    Biologics, Drugs, Human cells and tissue-based products, Medical 
devices, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, the 
Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, 21 CFR parts 1, 26, 99, 201, 203, 206, 
207, 310, 312, 314, 600, 601, 606, 607, 610, 660, 680, 801, 807, 812, 
814, 822, and 1271 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. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 
350d, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 
381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.


Sec.  1.101  [Amended]

0
2. Section 1.101 is amended in paragraph (d)(2)(i) by removing the 
words ``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'' and by adding in their place ``Food and Drug 
Administration, Center for Biologics Evaluation and Research, Document 
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver 
Spring, MD 20993-0002''.

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

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

    Authority: 5 U.S.C. 552; 15 U.S.C. 1453, 1454, 1455; 18 U.S.C. 
1905; 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 360c, 360d, 
360e, 360f, 360g, 360h, 360i, 360j, 360l, 360m, 371, 374, 381, 382, 
383, 393; 42 U.S.C. 216, 241, 242l, 262, 264, 265.


0
4. Appendix E to subpart A of part 26 is amended under the heading ``B. 
For the United States:'' in the entry for ``Biologics'' by removing the 
words ``Director, Office of Compliance and Biologics Quality (HFM-600), 
1401 Rockville Pike, Rockville, MD 20852, phone: 301-827-6190, fax: 
301-594-1944'' and by adding in their place ``Food and Drug 
Administration, Center for Biologics Evaluation and Research, Document 
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver 
Spring, MD 20993-0002, telephone: 240-402-9153, FAX: 301-595-1302''.

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

0
5. 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.


Sec.  99.201  [Amended]

0
6. Section 99.201 is amended in paragraph (c)(1) by removing the words 
``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'' and by adding in 
their place ``Food and Drug Administration, Center for Biologics 
Evaluation and Research, Document Control Center, 10903 New Hampshire 
Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002''.

PART 201--LABELING

0
7. 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.  201.25  [Amended]

0
8. Section 201.25 is amended in paragraph (d)(2) by removing the words 
``(requests involving a drug product) or to the Office of Compliance 
and Biologics Quality (HFM-600), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852 (requests involving a biological product)'' and by adding in 
their place ``(requests involving a drug product or biological product 
regulated by the Center for Drug Evaluation and Research) or to the 
Food and Drug Administration, Center for Biologics Evaluation and 
Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, 
Rm. G112, Silver Spring, MD 20993-0002 (requests involving a biological 
product regulated by the Center for Biologics Evaluation and 
Research)''.


Sec.  201.58  [Amended]

0
9. Section 201.58 is amended in the second sentence by removing the 
words ``Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, Suite 200 North, Rockville, MD 
20852-1448'' and by adding in their place ``Food and Drug 
Administration, Center for Biologics Evaluation and Research, Document 
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver 
Spring, MD 20993-0002''.

PART 203--PRESCRIPTION DRUG MARKETING

0
10. 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.


0
11. Section 203.12 is revised to read as follows:


Sec.  203.12  An appeal from an adverse decision by the district 
office.

    An appeal from an adverse decision by the district office involving 
insulin-containing drugs or human prescription drugs or biological 
products regulated by the Center for Drug Evaluation and Research may 
be made to the Office of Compliance, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002. An appeal from an adverse decision by the 
district office involving human prescription biological products 
regulated by the Center for Biologics Evaluation and Research may be 
made to the Food and Drug Administration, Center for Biologics 
Evaluation and Research, Document Control Center, 10903 New Hampshire 
Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002.

0
12. 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 
human prescription drugs or biological products regulated by the Center 
for Drug Evaluation and Research shall be made to the Division of 
Compliance

[[Page 18091]]

Risk Management and Surveillance, Office of Compliance, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002. Notifications and reports 
concerning human prescription biological products regulated by the 
Center for Biologics Evaluation and Research shall be made to the Food 
and Drug Administration, Center for Biologics Evaluation and Research, 
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, 
Silver Spring, MD 20993-0002.

0
13. Section 203.70 is amended by revising paragraph (b)(2) to read as 
follows:


Sec.  203.70  Application for a reward.

* * * * *
    (b) * * *
    (2) Food and Drug Administration, Center for Biologics Evaluation 
and Research, Office of Compliance and Biologics Quality (ATTN: 
Director), Document Control Center, 10903 New Hampshire Ave., Bldg. 71, 
Rm. G112, Silver Spring, MD 20993-0002, as appropriate.

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.


Sec.  206.7  [Amended]

0
15. Section 206.7 is amended in the first sentence of paragraph 
(b)(1)(i) by removing the words ``Center for Biologics Evaluation and 
Research (CBER), Food and Drug Administration, 1401 Rockville Pike, 
Suite 200N, Rockville, MD 20852-1448'' and by adding in their place 
``Food and Drug Administration, Center for Biologics Evaluation and 
Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, 
Rm. G112, Silver Spring, MD 20993-0002''.

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

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

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


Sec.  207.7  [Amended]

0
17. Section 207.7 is amended in the first sentence of paragraph (a) by 
removing the words ``Center for Biologics Evaluation and Research (HFM-
375), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448'' and 
by adding in their place ``Food and Drug Administration, Center for 
Biologics Evaluation and Research, Document Control Center, 10903 New 
Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002''.

PART 310--NEW DRUGS

0
18. 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.  310.503  [Amended]

0
19. Section 310.503 is amended in the last sentence of paragraph (f)(3) 
by removing the words ``Center for Biologics Evaluation and Research, 
Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20014'' 
and by adding in their place ``Food and Drug Administration, Center for 
Biologics Evaluation and Research, Document Control Center, 10903 New 
Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002''.

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION

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

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 
42 U.S.C. 262.


Sec.  312.140  [Amended]

0
21. Section 312.140 is amended in paragraph (a)(3) by removing the 
words ``Document Control Center (HFM-99), Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, Suite 200N, Rockville, MD 20852-1448'' and by adding in their 
place ``Food and Drug Administration, Center for Biologics Evaluation 
and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 
71, Rm. G112, Silver Spring, MD 20993-0002''.


Sec.  312.145  [Amended]

0
22. Section 312.145 is amended in the last sentence of paragraph (b) by 
removing the words ``Office of Communication, Training, and 
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448'' and by adding in their place ``Food and Drug 
Administration, Center for Biologics Evaluation and Research, Office of 
Communication, Outreach and Development, 10903 New Hampshire Ave., 
Bldg. 71, Rm. 3103, Silver Spring, MD 20993-0002''.


Sec.  312.310  [Amended]

0
23. Section 312.310 is amended in the second sentence of paragraph 
(d)(1) by removing ``301-827-1800'' and by adding in its place ``240-
402-8010''.

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

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

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


0
25. Section 314.440 is amended by revising paragraph (b) introductory 
text 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 Food and Drug Administration, Center for Biologics 
Evaluation and Research, Document Control Center, 10903 New Hampshire 
Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002, except 
applicants shall send a request for an opportunity for a hearing under 
Sec.  314.110 on the question of whether there are grounds for denying 
approval of an application to the Center for Biologics Evaluation and 
Research, ATTN: Director, at the same address.
* * * * *

PART 600--BIOLOGICAL PRODUCTS: GENERAL

0
26. 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.


Sec.  600.2  [Amended]

0
27. Section 600.2 is amended as follows:
0
a. In the first sentence of paragraph (a) by removing the words 
``Document Control Center (HFM-99), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448'' and by adding in their place ``Food 
and Drug Administration, Center for Biologics Evaluation and Research, 
Document Control Center, 10903 New Hampshire Ave., Bldg. 71,

[[Page 18092]]

Rm. G112, Silver Spring, MD 20993-0002''.
0
b. In the first sentence of paragraph (c)(1) by removing the words 
``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'' and by adding in their 
place ``Food and Drug Administration, Center for Biologics Evaluation 
and Research, ATTN: Sample Custodian, 10903 New Hampshire Ave., Bldg. 
75, Rm. G707, Silver Spring, MD 20993-0002''; and
0
c. In paragraph (c)(2), by removing the words ``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'' and by adding in their place ``Food and Drug 
Administration, Center for Biologics Evaluation and Research, ATTN: 
Sample Custodian, c/o White Oak Radiation Safety Program, 10903 New 
Hampshire Ave., Bldg. 52-72, Rm. G406A, Silver Spring, MD 20993-0002''.


Sec.  600.11  [Amended]

0
28. Section 600.11 is amended in paragraph (f)(6) by removing ``Sec.  
600.2'' and by adding in its place ``Sec.  600.2(a) or (b)''.

0
29. Section 600.14 is amended by revising paragraph (e)(1) 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 CBER Document Control 
Center (see mailing address in Sec.  600.2(a)), or submit 
electronically using CBER's electronic Web-based application.
* * * * *


Sec.  600.22  [Amended]

0
30. Section 600.22 is amended in paragraph (e) by removing ``Sec.  
600.2'' and by adding in its place ``Sec.  600.2(c)''.

PART 601--LICENSING

0
31. 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).

Sec.  601.2  [Amended]

0
32. Section 601.2 is amended in the first sentence of paragraph (a) by 
removing ``Sec.  600.2'' and by adding in its place ``Sec.  600.2(a) or 
(b)''.


Sec.  601.12  [Amended]

0
33. Section 601.12 is amended in paragraph (f)(4) by removing the words 
``, except that Form FDA-2567 (Transmittal of Labels and Circulars) or 
an equivalent form shall be used''.


Sec.  601.15  [Amended]

0
34. Section 601.15 is amended by removing ``Sec.  600.2'' in both 
places it appears and by adding in each place ``Sec.  600.2(c)''.


Sec.  601.28  [Amended]

0
35. The introductory text of Sec.  601.28 is amended by removing 
``Sec.  600.2'' and by adding in its place ``Sec.  600.2(a) or (b)''.


Sec.  601.29  [Amended]

0
36. Section 601.29 is amended in the last sentence of paragraph (b) by 
removing the words ``Office of Communication, Training, and 
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and 
Research, Food and Drug Administration (see mailing addresses in Sec.  
600.2 of this chapter)'' and by adding in their place ``Food and Drug 
Administration, Center for Biologics Evaluation and Research, Office of 
Communication, Outreach and Development, 10903 New Hampshire Ave., 
Bldg. 71, Rm. 3103, Silver Spring, MD 20993-0002''.


Sec.  601.70  [Amended]

0
37. Section 601.70 is amended in paragraph (d) by removing ``Sec.  
600.2'' and by adding in its place ``Sec.  600.2(a) or (b)''.

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

0
38. 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.  606.170  [Amended]

0
39. Section 606.170 is amended in the last sentence of paragraph (b) by 
removing the words ``(for mailing addresses, see Sec.  600.2 of this 
chapter)'' and by adding in their place ``(for mailing address, see 
Sec.  600.2(a) of this chapter)''.


0
40. Section 606.171 is amended by revising paragraph (e) to read as 
follows:


Sec.  606.171  Reporting of product deviations by licensed 
manufacturers, unlicensed registered blood establishments, and 
transfusion services.

* * * * *
    (e) Where do I report under this section? You must send the 
completed Form FDA 3486 to the Center for Biologics Evaluation and 
Research (CBER), either in paper or electronic format.
    (1) If you make a paper filing, send the completed form to the CBER 
Document Control Center (see mailing address in Sec.  600.2(a) of this 
chapter), and identify on the envelope that a BPDR (biological product 
deviation report) is enclosed; or
    (2) If you make an electronic filing, send the completed Form 
FDA3486 electronically using CBER's electronic Web-based application.
* * * * *

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

0
41. 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
42. Section 607.7 is amended in paragraphs (b) and (c) by removing both 
times it appears ``(HFM-375) (see mailing addresses in Sec.  600.2 of 
this chapter)'' and by adding in their place ``(see mailing address in 
Sec.  600.2(a) of this chapter)''.


Sec.  607.22  [Amended]

0
43. Section 607.22 is amended in the first sentence of paragraph (a) by 
removing the words ``Department of Health and Human Services, Food and 
Drug Administration, Center for Biologics Evaluation and Research (HFM-
375), (see mailing addresses in Sec.  600.2 of this chapter),'' and by 
adding in their place ``Food and Drug Administration, Center for 
Biologics Evaluation and Research (see mailing address in Sec.  
600.2(a) of this chapter),''.
0
44. Section 607.37 is revised to read as follows:


Sec.  607.37  Inspection of establishment registrations and blood 
product listings.

    (a) Any registration on Form FDA 2830 (Blood Establishment 
Registration and Product Listing) filed in paper or electronic format 
by the registrant will

[[Page 18093]]

be available for inspection under section 510(f) of the act, through 
the Center for Biologics Evaluation and Research Blood Establishment 
Registration Database Web site by using the CBER electronic Web-based 
application or by going in person to the Food and Drug Administration, 
Division of Dockets Management Public Reading Room (see address in 
Sec.  20.120(a) of this chapter). The following information submitted 
under the blood product listing requirements is illustrative of the 
type of information that will be available for public disclosure when 
it is compiled:
    (1) A list of all blood products.
    (2) A list of all blood products manufactured by each 
establishment.
    (3) A list of blood products discontinued.
    (4) All data or information that has already become a matter of 
public knowledge.
    (b) Other requests for information regarding blood establishment 
registrations and blood product listings should be directed to the Food 
and Drug Administration, Center for Biologics Evaluation and Research, 
Office of Communication, Outreach and Development, 10903 New Hampshire 
Ave., Bldg. 71, Rm. 3103, Silver Spring, MD 20993-0002.

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

0
45. 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.


Sec.  610.2  [Amended]

0
46. Section 610.2 is amended in the first sentence of paragraph (a) by 
removing ``Sec.  600.2'' and by adding in its place ``Sec.  600.2(c)'' 
and in the first sentence of paragraph (b) by removing ``Sec.  600.2'' 
and by adding in its place ``Sec.  600.2(c) of this chapter''.


Sec.  610.11  [Amended]

0
47. Section 610.11 is amended in the first sentence of paragraph (g)(2) 
by removing ``Sec.  600.2'' and by adding in its place ``Sec.  600.2(a) 
or (b)''.


Sec.  610.15  [Amended]

0
48. Section 610.15 is amended in paragraph (a)(3) by removing ``Sec.  
600.2'' and by adding in its place ``Sec.  600.2(a) or (b)''.

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

0
49. 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
50. Section 660.3 is amended by removing the words ``Center for 
Biologics Evaluation and Research (HFM-407) (see mailing addresses in 
Sec.  600.2 of this chapter)'' and by adding in their place ``Food and 
Drug Administration, Center for Biologics Evaluation and Research, 
Reagents and Standards Shipping, 10903 New Hampshire Ave., Bldg. 75, 
Rm. G704, Silver Spring, MD 20993-0002''.


Sec.  660.6  [Amended]

0
51. Section 660.6 is amended in paragraph (a)(2) by removing ``Sec.  
600.2'' and by adding in its place ``Sec.  600.2(c)'' and in the 
heading of paragraph (c) by removing the word ``Offical'' and by adding 
in its place ``Official''.


Sec.  660.22  [Amended]

0
52. Section 660.22 is amended in paragraph (b) by removing the words 
``Center for Biologics Evaluation and Research (HFM-407) (see mailing 
addresses in Sec.  600.2 of this chapter)'' and by adding in their 
place ``Food and Drug Administration, Center for Biologics Evaluation 
and Research, Reagents and Standards Shipping, 10903 New Hampshire 
Ave., Bldg. 75, Rm. G704, Silver Spring, MD 20993-0002''.


Sec.  660.36  [Amended]

0
53. Section 660.36 is amended as follows:
0
a. In paragraph (a) introductory text by removing the words ``(ATTN: 
HFM-672) (see mailing addresses in Sec.  600.2 of this chapter)'' and 
by adding in their place ``(see mailing addresses in Sec.  600.2(c) of 
this chapter)''.
0
b. In paragraph (b) by adding the words ``(see mailing addresses in 
Sec.  600.2(a) of this chapter)'' immediately following the words 
``Director, Center for Biologics Evaluation and Research''.
0
c. In paragraph (c) by adding the words ``(see mailing addresses in 
Sec.  600.2(c) of this chapter)'' immediately following the words 
``Director, Center for Biologics Evaluation and Research''.


Sec.  660.46  [Amended]

0
54. Section 660.46 is amended in paragraph (a)(2) introductory text by 
removing ``Sec.  600.2'' and by adding in its place ``Sec.  600.2(c)''.


Sec.  660.52  [Amended]

0
55. Section 660.52 is amended by removing the words ``Center for 
Biologics Evaluation and Research (HFM-407) (see mailing addresses in 
Sec.  600.2 of this chapter)'' and by adding in their place ``Food and 
Drug Administration, Center for Biologics Evaluation and Research, 
Reagents and Standards Shipping, 10903 New Hampshire Ave., Bldg. 75, 
Rm. G704, Silver Spring, MD 20993-0002''.

PART 680--ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS

0
56. 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
57. Section 680.1 is amended as follows:
0
a. In the last sentence of paragraph (b)(2)(iii) by removing the words 
``addresses in Sec.  600.2'' and by adding in their place ``address in 
Sec.  600.2(a) of this chapter''.
0
b. In paragraph (b)(3)(iv) by removing the word ``allergenic'' and by 
adding in its place the word ``Allergenic'' and by removing the words 
``addresses in Sec.  600.2'' and by adding in their place ``address in 
Sec.  600.2(a) of this chapter''.
0
c. In paragraph (c) by removing the words ``addresses in Sec.  600.2'' 
and by adding in their place ``address in Sec.  600.2(a) of this 
chapter''.

PART 801--LABELING

0
58. The authority citation for 21 CFR part 801 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.


Sec.  801.55  [Amended]

0
59. Section 801.55 is amended in paragraph (b)(1) by removing the words 
``Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448'' and by 
adding in their place ``Food and Drug Administration, Center for 
Biologics Evaluation and Research, Document Control Center, 10903 New 
Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002''.

[[Page 18094]]

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

0
60. 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.


Sec.  807.90  [Amended]

0
61. Section 807.90 is amended in paragraph (a)(2) by removing in the 
first sentence the words ``Document Control Center (HFM-99), Center for 
Biologics Evaluation and Research, Food and Drug Administration, 1401 
Rockville Pike, Suite 200N, Rockville, MD 20852-1448'' and by adding in 
their place ``Food and Drug Administration, Center for Biologics 
Evaluation and Research, Document Control Center, 10903 New Hampshire 
Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002'' and by 
removing in the second sentence ``at http://www.fda.gov/cber/dap/devlst.htm'' and by adding in its place ``by using the Center for 
Biologics Evaluation and Research electronic Web-based application''.

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

0
62. The authority citation for 21 CFR part 812 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 
360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241, 
262, 263b-263n.


Sec.  812.19  [Amended]

0
63. Section 812.19 is amended in paragraph (a)(2) by removing the words 
``Document Control Center (HFM-99), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448'' and by adding in their place ``Food 
and Drug Administration, Center for Biologics Evaluation and Research, 
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, 
Silver Spring, MD 20993-0002''.

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
64. The authority citation for 21 CFR part 814 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 
373, 374, 375, 379, 379e, 381.


Sec.  814.20  [Amended]

0
65. Section 814.20 is amended in paragraph (h)(2) by removing the words 
``Document Control Center (HFM-99), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448'' and by adding in their place ``Food 
and Drug Administration, Center for Biologics Evaluation and Research, 
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, 
Silver Spring, MD 20993-0002''.


Sec.  814.104  [Amended]

0
66. Section 814.104 is amended in paragraph (d)(2) by removing the 
words ``Document Control Center (HFM-99), Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, Suite 200N, Rockville, MD 20852-1448'' and by adding in their 
place ``Food and Drug Administration, Center for Biologics Evaluation 
and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 
71, Rm. G112, Silver Spring, MD 20993-0002''.

PART 822--POSTMARKET SURVEILLANCE

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

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


Sec.  822.8  [Amended]

0
68. Section 822.8 is amended by removing the words ``Document Control 
Center (HFM-99), Center for Biologics Evaluation and Research, Food and 
Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 
20852-1448'' and by adding in their place ``Food and Drug 
Administration, Center for Biologics Evaluation and Research, Document 
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver 
Spring, MD 20993-0002''.

PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED 
PRODUCTS

0
69. The authority citation for 21 CFR part 1271 continues to read as 
follows:

    Authority: 42 U.S.C. 216, 243, 263a, 264, 271.


Sec.  1271.22  [Amended]

0
70. Section 1271.22 is amended as follows:
0
a. In paragraph (b)(1) by removing the words ``Center for Biologics 
Evaluation and Research (HFM-775), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, Attention: Tissue 
Establishment Registration Coordinator'' and by adding in their place 
``Food and Drug Administration, Center for Biologics Evaluation and 
Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, 
Rm. G112, Silver Spring, MD 20993-0002, ATTN: Tissue Establishment 
Registration Coordinator''.
0
b. In paragraph (b)(3) by removing ``301-827-1800'' and by adding in 
its place ``240-402-8010''.
0
c. In paragraph (c)(1) by removing the words ``Center for Biologics 
Evaluation and Research (HFM-775), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, Attention: Tissue 
Establishment Registration Coordinator'' and by adding in their place 
the words ``Food and Drug Administration, Center for Biologics 
Evaluation and Research, Document Control Center, 10903 New Hampshire 
Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002, ATTN: Tissue 
Establishment Registration Coordinator''.
0
d. In paragraph (c)(2) by removing ``at http://www.fda.gov/cber/tissue/tisreg.htm'' and by adding in its place the words ``using the CBER 
electronic Web-based application''.

0
71. Section 1271.37 is revised to read as follows:


Sec.  1271.37  Will establishment registrations and HCT/P listings be 
available for inspection, and how do I request information on 
registrations and listings?

    (a) Any registration on Form FDA 3356 filed in paper or electronic 
format by each establishment will be available for public inspection 
through the Center for Biologics Evaluation and Research Human Cell and 
Tissue Establishment Registration--Public Query Web site by using the 
CBER electronic Web-based application or by going in person to the Food 
and Drug Administration, Division of Dockets Management Public Reading 
Room (see address in Sec.  20.120(a) of this chapter). The following 
information submitted under the HCT/P requirements is illustrative of 
the type of information that will be available for public disclosure 
when it is compiled:
    (1) A list of all HCT/P's;
    (2) A list of all HCT/P's manufactured by each establishment;
    (3) A list of all HCT/P's discontinued; and
    (4) All data or information that has already become a matter of 
public record.
    (b) You should direct your other requests for information regarding 
HCT/P establishment registrations and HCT/P listings to the Food and 
Drug Administration, Center for Biologics Evaluation and Research, 
Office of Communication, Outreach and Development, 10903 New Hampshire

[[Page 18095]]

Ave., Bldg. 71, Rm. 3103, Silver Spring, MD 20993-0002.

0
72. Section 1271.350 is amended:
0
a. In the first sentence of paragraph (a)(5) by removing the words 
``Center for Biologics Evaluation and Research (HFM-210), Food and Drug 
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448'' and by adding in their place ``Food and Drug Administration, 
Center for Biologics Evaluation and Research, Document Control Center, 
10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-
0002''; and
0
b. By revising paragraph (b)(3) to read as follows:


Sec.  1271.350  Reporting.

* * * * *
    (b) * * *
    (3) You must report each such HCT/P deviation that relates to a 
core CGTP requirement on Form FDA 3486 within 45 days of the discovery 
of the event either electronically using the Center for Biologics 
Evaluation and Research electronic Web-based application or by mail to 
the Food and Drug Administration, Center for Biologics Evaluation and 
Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, 
Rm. G112, Silver Spring, MD 20993-0002.

    Dated: March 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07268 Filed 4-2-15; 8:45 am]
 BILLING CODE 4164-01-P