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)

Page Range		18087-18095
FR Document		2015-07268
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 Issue 64 (Friday, April 3, 2015)
[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.

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

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
Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations 18087

DEPARTMENT OF HEALTH AND which applicants must submit this provision for purposes of accuracy
HUMAN SERVICES information related to applications or and consistency when referring to
products regulated by CBER or from products regulated by CBER or CDER.
Food and Drug Administration which the public can request • In § 203.37(e), the CBER unit and
information. Where appropriate, CBER address for submitting information in
21 CFR Parts 1, 26, 99, 201, 203, 206, Web addresses for obtaining or notifications and reports involving
207, 310, 312, 314, 600, 601, 606, 607, submitting forms and other information human prescription biological products
610, 660, 680, 801, 807, 812, 814, 822, are added or updated, and outdated regulated by CBER are updated to the
and 1271 addresses are removed. In certain
CBER Document Control Center on the
instances, mail previously addressed to
[Docket No. FDA–2015–N–0011] White Oak campus. Several other minor
specific CBER offices should now be
changes in terminology also are made to
Food and Drug Administration addressed to the CBER Document
this provision for purposes of accuracy
Regulations; Change of Addresses; Control Center.
The technical amendments, reflected and consistency when referring to
Technical Amendment products regulated by CBER or CDER.
in the regulatory text of this final rule,
AGENCY: Food and Drug Administration, are as follows: • In § 203.70(b)(2), the CBER unit and
HHS. • In § 1.101(d)(2)(i), the CBER unit address to apply for a reward when
Final rule; technical
ACTION: and address for submitting notifications providing information leading to a
amendment. regarding CBER-regulated products criminal proceeding or conviction
exported under section 802 of the related to the sale, purchase, or trade of
SUMMARY: The Food and Drug Federal Food, Drug, and Cosmetic Act a drug sample are updated to the CBER
Administration (FDA) is amending its (21 U.S.C. 382) are updated to the CBER Document Control Center on the White
regulations to update address Document Control Center on the White Oak campus.
information for the Center for Biologics Oak campus.
Evaluation and Research (CBER) as a • In Appendix E to subpart A of part • In § 206.7(b)(1)(i), the CBER unit
result of the recent relocation of CBER 26, the contact information provided for and address for requesting an exemption
offices and laboratories to the FDA CBER, including its address, telephone, from imprinting requirements involving
White Oak campus in Silver Spring, and fax numbers to be used in the two- human drug products in solid oral
MD, as well as make other related way alert system established in dosage form are updated to the CBER
technical revisions. These changes are accordance with the 1998 ‘‘Agreement Document Control Center on the White
being made to ensure the accuracy of on Mutual Recognition Between the Oak campus.
the Agency’s regulations. United States of America and the • In § 207.7(a), the CBER unit and
DATES: This rule is effective April 3, European Community,’’ is updated to address for submitting blood
2015. reflect CBER’s move to the White Oak establishment registration and product
campus. listing information are updated to the
FOR FURTHER INFORMATION CONTACT: John • In § 99.201(c)(1), the CBER unit and CBER Document Control Center on the
Reilly, Center for Biologics Evaluation address to send a submission and White Oak campus.
and Research, Food and Drug certification statement, or to send an
Administration, 10903 New Hampshire • In § 310.503(f)(3), the CBER unit
application for exemption relating to the
Ave., Bldg. 71, Rm. 7301, Silver Spring, and address for submitting an
dissemination of information on an
MD 20993–0002, 240–402–7911. investigational new drug (IND)
unapproved/new use regarding a
SUPPLEMENTARY INFORMATION: FDA is application or an application for a
biological product or device is updated
amending its regulations in parts 1, 26, biologics license under section 351 of
to the CBER Document Control Center
99, 201, 203, 206, 207, 310, 312, 314, the Public Health Service Act with
on the White Oak campus.
600, 601, 606, 607, 610, 660, 680, 801, • In § 201.25(d)(2), the CBER unit and regard to certain radioactive drugs
807, 812, 814, 822, and 1271 (21 CFR address for submitting a request for considered biologics are updated to the
parts 1, 26, 99, 201, 203, 206, 207, 310, exemption from the bar code label CBER Document Control Center on the
312, 314, 600, 601, 606, 607, 610, 660, requirement for biological products White Oak campus.
680, 801, 807, 812, 814, 822, and 1271) regulated by CBER are updated to the • In § 312.140(a)(3), the address for
to reflect the following changes: (1) The CBER Document Control Center on the submitting an IND application involving
relocation of CBER offices and White Oak campus. Several other minor biological products regulated by CBER
laboratories from various Rockville and changes are made to this provision for is updated to the White Oak campus.
Bethesda, MD, locations to the FDA purposes of clarity and correctness in • In § 312.145(b), the CBER unit and
White Oak campus in Silver Spring, referring to products regulated by CBER address from which to request a list of
MD; (2) the change of address of CBER’s or CDER. CBER guidances are updated to the
Document Control Center; (3) updating • In § 201.58, the CBER unit and Office of Communication, Outreach and
the names of certain CBER address for submitting a request for Development and the White Oak
organizational units referenced in the waiver from certain labeling campus.
regulations; (4) revising certain cross- requirements are updated to the CBER
references to be more specific and Document Control Center on the White • In § 312.310(d)(1), the CBER local
thereby facilitate locating the Oak campus. telephone number for requesting
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appropriate mailing addresses for • In § 203.12, the CBER unit and emergency expanded access use of
submissions, requests, and other address for submitting an appeal from investigational biological drug products
correspondence relating to biological an adverse decision relating to the regulated by CBER is updated.
products regulated by CBER and the reimportation of biological products • In § 314.440(b), the CBER addresses
Center for Drug Evaluation and Research regulated by CBER are updated to the for submitting new drug applications
(CDER); and (5) making other minor CBER Document Control Center on the and other correspondence involving
changes to ensure accuracy. The White Oak campus. Several other minor certain drug products used in the
updated addresses include locations to changes in terminology also are made to collection, processing, or storage of

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18088 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations

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

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and Standards Shipping and the White campus. And in § 1271.22(c)(2), the 21 CFR Part 203
Oak campus. specific CBER Web address for
• In § 680.1(b)(2)(iii), (b)(3)(iv), and Labeling, Prescription drugs,
submitting Form FDA 3356
(c), the cross-reference ‘‘§ 600.2’’ is Reporting and recordkeeping
electronically is removed, and a more
changed to ‘‘§ 600.2(a) of this chapter’’ requirements, Warehouses.
general reference for submitting this
to clarify using the updated CBER form electronically is added in its place. 21 CFR Part 206
Document Control Center address when • Section 1271.37(a) is updated to
submitting the requested source Drugs.
reflect that registrant and product list
material information regarding information filed on Form FDA 3356 for 21 CFR Part 207
allergenic products.
HCT/Ps, previously made available for Drugs, Reporting and recordkeeping
• In § 801.55(b)(1), the CBER unit and
public inspection at CBER offices, can requirements.
address for requesting an exception or
now be accessed through CBER’s Web
alternative to a unique device identifier 21 CFR Part 310
site or by visiting FDA’s Division of
for devices regulated by CBER are
Dockets Management. In § 1271.37(b), Administrative practice and
updated to the CBER Document Control
the name of the CBER unit and address procedure, Drugs, Labeling, Medical
Center on the White Oak campus.
• In § 807.90(a)(2), the address for for requesting other information devices, Reporting and recordkeeping
submitting a premarket notification for regarding HCT/P establishment requirements.
devices regulated by CBER is updated to registrations and HCT/P listings are
updated to the Office of 21 CFR Part 312
the White Oak campus; the specific
CBER Web address for obtaining Communication, Outreach and Drugs, Exports, Imports,
information about devices regulated by Development and the White Oak Investigations, Labeling, Medical
CBER is removed, and a more general campus. research, Reporting and recordkeeping
reference for obtaining this information • In § 1271.350(a)(5), the CBER unit requirements, Safety.
on the CBER’s Web site is added in its and address for submitting adverse 21 CFR Part 314
place. reaction reports involving an HCT/P
• In § 812.19(a)(2), the address for have been updated to the CBER Administrative practice and
sending correspondence in connection Document Control Center on the White procedure, Confidential business
with investigational device exemptions Oak campus. In § 1271.350(b)(3), the information, Drugs, Reporting and
(IDEs) involving devices regulated by address for obtaining and submitting recordkeeping requirements.
CBER is updated to the White Oak Form FDA 3486 by mail has been 21 CFR Part 600
campus. updated to the CBER Document Control
• In § 814.20(h)(2), the address for Center on the White Oak campus. The Biologics, Reporting and
submitting a premarket approval specific CBER Web addresses for recordkeeping requirements.
application (PMA), a PMA amendment, obtaining and submitting the form 21 CFR Part 601
a PMA supplement, or correspondence electronically have been replaced by a
involving a PMA for devices regulated more general reference to using CBER’s Administrative practice and
by CBER is updated to the White Oak electronic Web-based application. procedure, Biologics, Confidential
campus. business information.
Publication of this document
• In § 814.104(d)(2), the address for 21 CFR Part 606
constitutes final action of these changes
submitting an original PMA seeking a
under the Administrative Procedure Act Blood, Labeling, Laboratories,
humanitarian device exemption (HDE),
(5 U.S.C. 553). FDA has determined that Reporting and recordkeeping
or related amendments or supplements,
notice and public comment are requirements.
or other correspondence relating to an
unnecessary because this amendment to
HDE for devices regulated by CBER is 21 CFR Part 607
the regulations provides only technical
updated to the White Oak campus.
changes to update addresses and other
• In § 822.8, the address for Blood.
information, and is nonsubstantive.
submitting a postmarket surveillance 21 CFR Parts 610 and 660
plan for devices regulated by CBER is List of Subjects
updated to the White Oak campus. Biologics, Labeling, Reporting and
• The address for submitting a 21 CFR Part 1 recordkeeping requirements.
reclassification petition for devices Cosmetics, Drugs, Exports, Food 21 CFR Part 680
regulated by CBER in § 860.123(b)(1) labeling, Imports, Labeling, Reporting
was updated to the White Oak campus and recordkeeping requirements. Biologics, Blood, Reporting and
in a previous FDA document published recordkeeping requirements.
in the Federal Register on December 24, 21 CFR Part 26
21 CFR Part 801
2014 (79 FR 77387).
• In § 1271.22(b), the CBER address Animal drugs, Biologics, Drugs, Labeling, Medical devices, Reporting
and local telephone number for Exports, Imports. and recordkeeping requirements.
requesting Form FDA 3356 involving 21 CFR Part 99 21 CFR Part 807
establishment registration and listing for
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human cells, tissues, and cellular and Administrative practice and Confidential business information,
tissue-based products (HCT/Ps) are procedure, Biologics, Drugs, Medical Imports, Medical devices, Reporting and
updated to the Document Control Center devices, Reporting and recordkeeping recordkeeping requirements.
on the White Oak campus. In requirements.
21 CFR Part 812
§ 1271.22(c)(1), the CBER unit and 21 CFR Part 201
address for submitting Form FDA 3356 Health records, Medical devices,
are updated to the CBER Document Drugs, Labeling, Reporting and Medical research, Reporting and
Control Center on the White Oak recordkeeping requirements. recordkeeping requirements.

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18090 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations

21 CFR Part 814 360e, 360f, 360g, 360h, 360i, 360j, 360l, Research) or to the Food and Drug
360m, 371, 374, 381, 382, 383, 393; 42 U.S.C. Administration, Center for Biologics
Administrative practice and 216, 241, 242l, 262, 264, 265.
procedure, Confidential business Evaluation and Research, Document
information, Medical devices, Medical ■ 4. Appendix E to subpart A of part 26 Control Center, 10903 New Hampshire
research, Reporting and recordkeeping is amended under the heading ‘‘B. For Ave., Bldg. 71, Rm. G112, Silver Spring,
requirements. the United States:’’ in the entry for MD 20993–0002 (requests involving a
‘‘Biologics’’ by removing the words biological product regulated by the
21 CFR Part 822 ‘‘Director, Office of Compliance and Center for Biologics Evaluation and
Medical devices, Reporting and Biologics Quality (HFM–600), 1401 Research)’’.
recordkeeping requirements. Rockville Pike, Rockville, MD 20852,
§ 201.58 [Amended]
phone: 301–827–6190, fax: 301–594–
21 CFR Part 1271 1944’’ and by adding in their place ■ 9. Section 201.58 is amended in the
Biologics, Drugs, Human cells and ‘‘Food and Drug Administration, Center second sentence by removing the words
tissue-based products, Medical devices, for Biologics Evaluation and Research, ‘‘Center for Biologics Evaluation and
Reporting and recordkeeping Document Control Center, 10903 New Research, Food and Drug
requirements. Hampshire Ave., Bldg. 71, Rm. G112, Administration, 1401 Rockville Pike,
Therefore, under the Federal Food, Silver Spring, MD 20993–0002, Suite 200 North, Rockville, MD 20852–
Drug, and Cosmetic Act, the Public telephone: 240–402–9153, FAX: 301– 1448’’ and by adding in their place
Health Service Act, and under authority 595–1302’’. ‘‘Food and Drug Administration, Center
delegated to the Commissioner of Food for Biologics Evaluation and Research,
and Drugs, 21 CFR parts 1, 26, 99, 201, PART 99—DISSEMINATION OF Document Control Center, 10903 New
203, 206, 207, 310, 312, 314, 600, 601, INFORMATION ON UNAPPROVED/ Hampshire Ave., Bldg. 71, Rm. G112,
606, 607, 610, 660, 680, 801, 807, 812, NEW USES FOR MARKETED DRUGS, Silver Spring, MD 20993–0002’’.
814, 822, and 1271 are amended as BIOLOGICS, AND DEVICES
PART 203—PRESCRIPTION DRUG
follows: ■ 5. The authority citation for 21 CFR MARKETING
PART 1—GENERAL ENFORCEMENT part 99 continues to read as follows:
■ 10. The authority citation for 21 CFR
REGULATIONS Authority: 21 U.S.C. 321, 331, 351, 352,
355, 360, 360c, 360e, 360aa–360aaa–6, 371, part 203 continues to read as follows:
■ 1. The authority citation for 21 CFR and 374; 42 U.S.C. 262. Authority: 21 U.S.C. 331, 333, 351, 352,
part 1 continues to read as follows: 353, 360, 371, 374, 381.
§ 99.201 [Amended]
Authority: 15 U.S.C. 1333, 1453, 1454, ■ 11. Section 203.12 is revised to read
1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. ■ 6. Section 99.201 is amended in as follows:
321, 331, 332, 333, 334, 335a, 343, 350c, paragraph (c)(1) by removing the words
350d, 352, 355, 360b, 360ccc, 360ccc–1, ‘‘the Advertising and Promotional § 203.12 An appeal from an adverse
360ccc–2, 362, 371, 374, 381, 382, 387, 387a, Labeling Staff (HFM–602), Center for decision by the district office.
387c, 393; 42 U.S.C. 216, 241, 243, 262, 264. Biologics Evaluation and Research, An appeal from an adverse decision
Food and Drug Administration, 1401 by the district office involving insulin-
§ 1.101 [Amended] containing drugs or human prescription
Rockville Pike, Suite 200N, Rockville,
■ 2. Section 1.101 is amended in MD 20852–1448’’ and by adding in their drugs or biological products regulated
paragraph (d)(2)(i) by removing the place ‘‘Food and Drug Administration, by the Center for Drug Evaluation and
words ‘‘Division of Case Management Center for Biologics Evaluation and Research may be made to the Office of
(HFM–610), Office of Compliance and Research, Document Control Center, Compliance, Center for Drug Evaluation
Biologics Quality, Center for Biologics 10903 New Hampshire Ave., Bldg. 71, and Research, Food and Drug
Evaluation and Research, Food and Rm. G112, Silver Spring, MD 20993– Administration, 10903 New Hampshire
Drug Administration, 1401 Rockville 0002’’. Ave., Silver Spring, MD 20993–0002.
Pike, Suite 200N, Rockville, MD 20852– An appeal from an adverse decision by
1448’’ and by adding in their place PART 201—LABELING the district office involving human
‘‘Food and Drug Administration, Center prescription biological products
for Biologics Evaluation and Research, ■ 7. The authority citation for 21 CFR regulated by the Center for Biologics
Document Control Center, 10903 New part 201 continues to read as follows: Evaluation and Research may be made
Hampshire Ave., Bldg. 71, Rm. G112, Authority: 21 U.S.C. 321, 331, 351, 352, to the Food and Drug Administration,
Silver Spring, MD 20993–0002’’. 353, 355, 358, 360, 360b, 360gg–360ss, 371, Center for Biologics Evaluation and
374, 379e; 42 U.S.C. 216, 241, 262, 264. Research, Document Control Center,
PART 26—MUTUAL RECOGNITION OF 10903 New Hampshire Ave., Bldg. 71,
§ 201.25 [Amended]
PHARMACEUTICAL GOOD Rm. G112, Silver Spring, MD 20993–
MANUFACTURING PRACTICE ■ 8. Section 201.25 is amended in 0002.
REPORTS, MEDICAL DEVICE QUALITY paragraph (d)(2) by removing the words ■ 12. Section 203.37 is amended by
SYSTEM AUDIT REPORTS, AND ‘‘(requests involving a drug product) or revising paragraph (e) to read as follows:
CERTAIN MEDICAL DEVICE PRODUCT to the Office of Compliance and
EVALUATION REPORTS: UNITED Biologics Quality (HFM–600), Center for § 203.37 Investigation and notification
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STATES AND THE EUROPEAN Biologics Evaluation and Research, requirements.
COMMUNITY Food and Drug Administration, 1401 * * * * *
Rockville Pike, Rockville, MD 20852 (e) Whom to notify at FDA.
■ 3. The authority citation for 21 CFR (requests involving a biological Notifications and reports concerning
part 26 continues to read as follows: product)’’ and by adding in their place human prescription drugs or biological
Authority: 5 U.S.C. 552; 15 U.S.C. 1453, ‘‘(requests involving a drug product or products regulated by the Center for
1454, 1455; 18 U.S.C. 1905; 21 U.S.C. 321, biological product regulated by the Drug Evaluation and Research shall be
331, 351, 352, 355, 360, 360b, 360c, 360d, Center for Drug Evaluation and made to the Division of Compliance

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Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations 18091

Risk Management and Surveillance, removing the words ‘‘Center for Evaluation and Research, Office of
Office of Compliance, Center for Drug Biologics Evaluation and Research Communication, Outreach and
Evaluation and Research, Food and (HFM–375), 1401 Rockville Pike, Suite Development, 10903 New Hampshire
Drug Administration, 10903 New 200N, Rockville, MD 20852–1448’’ and Ave., Bldg. 71, Rm. 3103, Silver Spring,
Hampshire Ave., Silver Spring, MD by adding in their place ‘‘Food and Drug MD 20993–0002’’.
20993–0002. Notifications and reports Administration, Center for Biologics
concerning human prescription Evaluation and Research, Document § 312.310 [Amended]
biological products regulated by the Control Center, 10903 New Hampshire ■ 23. Section 312.310 is amended in the
Center for Biologics Evaluation and Ave., Bldg. 71, Rm. G112, Silver Spring, second sentence of paragraph (d)(1) by
Research shall be made to the Food and MD 20993–0002’’. removing ‘‘301–827–1800’’ and by
Drug Administration, Center for adding in its place ‘‘240–402–8010’’.
Biologics Evaluation and Research, PART 310—NEW DRUGS
Document Control Center, 10903 New PART 314—APPLICATIONS FOR FDA
Hampshire Ave., Bldg. 71, Rm. G112, ■ 18. The authority citation for 21 CFR APPROVAL TO MARKET A NEW DRUG
Silver Spring, MD 20993–0002. part 310 continues to read as follows:
■ 13. Section 203.70 is amended by Authority: 21 U.S.C. 321, 331, 351, 352, ■ 24. The authority citation for 21 CFR
revising paragraph (b)(2) to read as 353, 355, 360b–360f, 360j, 361(a), 371, 374, part 314 continues to read as follows:
375, 379e; 42 U.S.C. 216, 241, 242(a), 262, Authority: 21 U.S.C. 321, 331, 351, 352,
follows: 263b–263n. 353, 355, 356, 356a, 356b, 356c, 371, 374,
§ 203.70 Application for a reward. 379e.
§ 310.503 [Amended]
* * * * * ■ 25. Section 314.440 is amended by
(b) * * * ■ 19. Section 310.503 is amended in the
last sentence of paragraph (f)(3) by revising paragraph (b) introductory text
(2) Food and Drug Administration,
removing the words ‘‘Center for to read as follows:
Center for Biologics Evaluation and
Research, Office of Compliance and Biologics Evaluation and Research, § 314.440 Addresses for applications and
Biologics Quality (ATTN: Director), Food and Drug Administration, 8800 abbreviated applications.
Document Control Center, 10903 New Rockville Pike, Bethesda, MD 20014’’
* * * * *
Hampshire Ave., Bldg. 71, Rm. G112, and by adding in their place ‘‘Food and
Drug Administration, Center for (b) Applicants shall send applications
Silver Spring, MD 20993–0002, as and other correspondence relating to
appropriate. Biologics Evaluation and Research,
Document Control Center, 10903 New matters covered by this part for the drug
Hampshire Ave., Bldg. 71, Rm. G112, products listed below to the Food and
PART 206—IMPRINTING OF SOLID Drug Administration, Center for
ORAL DOSAGE FORM DRUG Silver Spring, MD 20993–0002’’.
Biologics Evaluation and Research,
PRODUCTS FOR HUMAN USE Document Control Center, 10903 New
PART 312—INVESTIGATIONAL NEW
■ 14. The authority citation for 21 CFR DRUG APPLICATION Hampshire Ave., Bldg. 71, Rm. G112,
part 206 continues to read as follows: Silver Spring, MD 20993–0002, except
■ 20. The authority citation for 21 CFR applicants shall send a request for an
Authority: 21 U.S.C. 321, 331, 351, 352, part 312 continues to read as follows: opportunity for a hearing under
355, 371; 42 U.S.C. 262.
Authority: 21 U.S.C. 321, 331, 351, 352, § 314.110 on the question of whether
§ 206.7 [Amended] 353, 355, 360bbb, 371; 42 U.S.C. 262. there are grounds for denying approval
of an application to the Center for
■ 15. Section 206.7 is amended in the § 312.140 [Amended] Biologics Evaluation and Research,
first sentence of paragraph (b)(1)(i) by
■ 21. Section 312.140 is amended in ATTN: Director, at the same address.
removing the words ‘‘Center for
Biologics Evaluation and Research paragraph (a)(3) by removing the words * * * * *
(CBER), Food and Drug Administration, ‘‘Document Control Center (HFM–99),
Center for Biologics Evaluation and PART 600—BIOLOGICAL PRODUCTS:
1401 Rockville Pike, Suite 200N,
Research, Food and Drug GENERAL
Rockville, MD 20852–1448’’ and by
adding in their place ‘‘Food and Drug Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448’’ ■ 26. The authority citation for 21 CFR
Administration, Center for Biologics part 600 continues to read as follows:
Evaluation and Research, Document and by adding in their place ‘‘Food and
Control Center, 10903 New Hampshire Drug Administration, Center for Authority: 21 U.S.C. 321, 351, 352, 353,
Biologics Evaluation and Research, 355, 360, 360i, 371, 374; 42 U.S.C. 216, 262,
Ave., Bldg. 71, Rm. G112, Silver Spring,
Document Control Center, 10903 New 263, 263a, 264, 300aa–25.
MD 20993–0002’’.
Hampshire Ave., Bldg. 71, Rm. G112, § 600.2 [Amended]
PART 207—REGISTRATION OF Silver Spring, MD 20993–0002’’.
PRODUCERS OF DRUGS AND LISTING ■ 27. Section 600.2 is amended as
§ 312.145 [Amended] follows:
OF DRUGS IN COMMERCIAL
DISTRIBUTION ■ 22. Section 312.145 is amended in the ■ a. In the first sentence of paragraph (a)
last sentence of paragraph (b) by by removing the words ‘‘Document
■ 16. The authority citation for 21 CFR removing the words ‘‘Office of Control Center (HFM–99), Center for
asabaliauskas on DSK5VPTVN1PROD with RULES

part 207 continues to read as follows: Communication, Training, and Biologics Evaluation and Research,
Authority: 21 U.S.C. 321, 331, 351, 352, Manufacturers Assistance (HFM–40), Food and Drug Administration, 1401
355, 360, 360b, 371, 374, 381, 393; 42 U.S.C. Center for Biologics Evaluation and Rockville Pike, Suite 200N, Rockville,
262, 264, 271. Research, Food and Drug MD 20852–1448’’ and by adding in their
Administration, 1401 Rockville Pike, place ‘‘Food and Drug Administration,
§ 207.7 [Amended] Rockville, MD 20852–1448’’ and by Center for Biologics Evaluation and
■ 17. Section 207.7 is amended in the adding in their place ‘‘Food and Drug Research, Document Control Center,
first sentence of paragraph (a) by Administration, Center for Biologics 10903 New Hampshire Ave., Bldg. 71,

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18092 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations

Rm. G112, Silver Spring, MD 20993– L. 105–115, 111 Stat. 2322 (21 U.S.C. 355 ■ 40. Section 606.171 is amended by
0002’’. note). revising paragraph (e) to read as follows:
■ b. In the first sentence of paragraph
§ 601.2 [Amended] § 606.171 Reporting of product deviations
(c)(1) by removing the words ‘‘Sample by licensed manufacturers, unlicensed
Custodian (ATTN: HFM–672), Food and ■ 32. Section 601.2 is amended in the registered blood establishments, and
Drug Administration, Center for first sentence of paragraph (a) by transfusion services.
Biologics Evaluation and Research, removing ‘‘§ 600.2’’ and by adding in its
* * * * *
Bldg. NLRC–B, Rm. 113, 5516 place ‘‘§ 600.2(a) or (b)’’. (e) Where do I report under this
Nicholson Lane, Kensington, MD section? You must send the completed
§ 601.12 [Amended]
20895’’ and by adding in their place Form FDA 3486 to the Center for
‘‘Food and Drug Administration, Center ■ 33. Section 601.12 is amended in
Biologics Evaluation and Research
for Biologics Evaluation and Research, paragraph (f)(4) by removing the words
(CBER), either in paper or electronic
ATTN: Sample Custodian, 10903 New ‘‘, except that Form FDA–2567
format.
Hampshire Ave., Bldg. 75, Rm. G707, (Transmittal of Labels and Circulars) or (1) If you make a paper filing, send
Silver Spring, MD 20993–0002’’; and an equivalent form shall be used’’. the completed form to the CBER
■ c. In paragraph (c)(2), by removing the § 601.15 [Amended] Document Control Center (see mailing
words ‘‘Sample Custodian (ATTN: address in § 600.2(a) of this chapter),
HFM–672), Food and Drug ■ 34. Section 601.15 is amended by and identify on the envelope that a
Administration, Center for Biologics removing ‘‘§ 600.2’’ in both places it BPDR (biological product deviation
Evaluation and Research, Nicholson appears and by adding in each place report) is enclosed; or
Lane Research Center, c/o Radiation ‘‘§ 600.2(c)’’. (2) If you make an electronic filing,
Safety Office, National Institutes of § 601.28 [Amended] send the completed Form FDA3486
Health, 21 Wilson Dr., Rm. 107, electronically using CBER’s electronic
Bethesda, MD 20892–6780’’ and by ■ 35. The introductory text of § 601.28 Web-based application.
adding in their place ‘‘Food and Drug is amended by removing ‘‘§ 600.2’’ and
by adding in its place ‘‘§ 600.2(a) or (b)’’. * * * * *
Administration, Center for Biologics
Evaluation and Research, ATTN: § 601.29 [Amended] PART 607—ESTABLISHMENT
Sample Custodian, c/o White Oak REGISTRATION AND PRODUCT
■ 36. Section 601.29 is amended in the LISTING FOR MANUFACTURERS OF
Radiation Safety Program, 10903 New
last sentence of paragraph (b) by HUMAN BLOOD AND BLOOD
Hampshire Ave., Bldg. 52–72, Rm.
removing the words ‘‘Office of PRODUCTS
G406A, Silver Spring, MD 20993–0002’’.
Communication, Training, and
§ 600.11 [Amended] Manufacturers Assistance (HFM–40), ■ 41. The authority citation for 21 CFR
Center for Biologics Evaluation and part 607 continues to read as follows:
■ 28. Section 600.11 is amended in
Research, Food and Drug Authority: 21 U.S.C. 321, 331, 351, 352,
paragraph (f)(6) by removing ‘‘§ 600.2’’
Administration (see mailing addresses 355, 360, 371, 374, 381, 393; 42 U.S.C. 262,
and by adding in its place ‘‘§ 600.2(a) or
in § 600.2 of this chapter)’’ and by 264, 271.
(b)’’.
adding in their place ‘‘Food and Drug
■ 29. Section 600.14 is amended by Administration, Center for Biologics § 607.7 [Amended]
revising paragraph (e)(1) to read as Evaluation and Research, Office of ■ 42. Section 607.7 is amended in
follows: Communication, Outreach and paragraphs (b) and (c) by removing both
§ 600.14 Reporting of biological product
Development, 10903 New Hampshire times it appears ‘‘(HFM–375) (see
deviations by licensed manufacturers. Ave., Bldg. 71, Rm. 3103, Silver Spring, mailing addresses in § 600.2 of this
MD 20993–0002’’. chapter)’’ and by adding in their place
* * * * *
‘‘(see mailing address in § 600.2(a) of
(e) Where do I report under this § 601.70 [Amended]
this chapter)’’.
section? (1) For biological products ■ 37. Section 601.70 is amended in
regulated by the Center for Biologics paragraph (d) by removing ‘‘§ 600.2’’ § 607.22 [Amended]
Evaluation and Research (CBER), send and by adding in its place ‘‘§ 600.2(a) or ■ 43. Section 607.22 is amended in the
the completed Form FDA 3486 to the (b)’’. first sentence of paragraph (a) by
CBER Document Control Center (see removing the words ‘‘Department of
mailing address in § 600.2(a)), or submit PART 606—CURRENT GOOD Health and Human Services, Food and
electronically using CBER’s electronic MANUFACTURING PRACTICE FOR Drug Administration, Center for
Web-based application. BLOOD AND BLOOD COMPONENTS Biologics Evaluation and Research
* * * * * (HFM–375), (see mailing addresses in
■ 38. The authority citation for 21 CFR
§ 600.22 [Amended] § 600.2 of this chapter),’’ and by adding
part 606 continues to read as follows:
in their place ‘‘Food and Drug
■ 30. Section 600.22 is amended in Authority: 21 U.S.C. 321, 331, 351, 352, Administration, Center for Biologics
paragraph (e) by removing ‘‘§ 600.2’’ and 355, 360, 360j, 371, 374; 42 U.S.C. 216, 262, Evaluation and Research (see mailing
by adding in its place ‘‘§ 600.2(c)’’. 263a, 264.
address in § 600.2(a) of this chapter),’’.
■ 44. Section 607.37 is revised to read
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§ 606.170 [Amended]
PART 601—LICENSING as follows:
■ 39. Section 606.170 is amended in the
■ 31. The authority citation for 21 CFR last sentence of paragraph (b) by § 607.37 Inspection of establishment
part 601 continues to read as follows: removing the words ‘‘(for mailing registrations and blood product listings.
Authority: 15 U.S.C. 1451–1561; 21 U.S.C. addresses, see § 600.2 of this chapter)’’ (a) Any registration on Form FDA
321, 351, 352, 353, 355, 356b, 360, 360c– and by adding in their place ‘‘(for 2830 (Blood Establishment Registration
360f, 360h–360j, 371, 374, 379e, 381; 42 mailing address, see § 600.2(a) of this and Product Listing) filed in paper or
U.S.C. 216, 241, 262, 263, 264; sec 122, Pub. chapter)’’. electronic format by the registrant will

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Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations 18093

be available for inspection under section PART 660—ADDITIONAL STANDARDS removing ‘‘§ 600.2’’ and by adding in its
510(f) of the act, through the Center for FOR DIAGNOSTIC SUBSTANCES FOR place ‘‘§ 600.2(c)’’.
Biologics Evaluation and Research LABORATORY TESTS
§ 660.52 [Amended]
Blood Establishment Registration
Database Web site by using the CBER ■ 49. The authority citation for 21 CFR ■ 55. Section 660.52 is amended by
electronic Web-based application or by part 660 continues to read as follows: removing the words ‘‘Center for
going in person to the Food and Drug Authority: 21 U.S.C. 321, 331, 351, 352, Biologics Evaluation and Research
Administration, Division of Dockets 353, 355, 360, 360c, 360d, 360h, 360i, 371, (HFM–407) (see mailing addresses in
Management Public Reading Room (see 372; 42 U.S.C. 216, 262, 263, 263a, 264. § 600.2 of this chapter)’’ and by adding
address in § 20.120(a) of this chapter). § 660.3 [Amended] in their place ‘‘Food and Drug
The following information submitted Administration, Center for Biologics
under the blood product listing ■ 50. Section 660.3 is amended by Evaluation and Research, Reagents and
requirements is illustrative of the type removing the words ‘‘Center for Standards Shipping, 10903 New
of information that will be available for Biologics Evaluation and Research Hampshire Ave., Bldg. 75, Rm. G704,
public disclosure when it is compiled: (HFM–407) (see mailing addresses in Silver Spring, MD 20993–0002’’.
§ 600.2 of this chapter)’’ and by adding
(1) A list of all blood products. in their place ‘‘Food and Drug PART 680—ADDITIONAL STANDARDS
(2) A list of all blood products Administration, Center for Biologics FOR MISCELLANEOUS PRODUCTS
manufactured by each establishment. Evaluation and Research, Reagents and
(3) A list of blood products Standards Shipping, 10903 New ■ 56. The authority citation for 21 CFR
discontinued. Hampshire Ave., Bldg. 75, Rm. G704, part 680 continues to read as follows:
Silver Spring, MD 20993–0002’’.
(4) All data or information that has Authority: 21 U.S.C. 321, 351, 352, 353,
already become a matter of public § 660.6 [Amended] 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a,
knowledge. 264.
■ 51. Section 660.6 is amended in
(b) Other requests for information paragraph (a)(2) by removing ‘‘§ 600.2’’ § 680.1 [Amended]
regarding blood establishment and by adding in its place ‘‘§ 600.2(c)’’
registrations and blood product listings and in the heading of paragraph (c) by ■ 57. Section 680.1 is amended as
removing the word ‘‘Offical’’ and by follows:
should be directed to the Food and Drug
Administration, Center for Biologics adding in its place ‘‘Official’’. ■ a. In the last sentence of paragraph
Evaluation and Research, Office of (b)(2)(iii) by removing the words
§ 660.22 [Amended] ‘‘addresses in § 600.2’’ and by adding in
Communication, Outreach and
Development, 10903 New Hampshire ■ 52. Section 660.22 is amended in their place ‘‘address in § 600.2(a) of this
Ave., Bldg. 71, Rm. 3103, Silver Spring, paragraph (b) by removing the words chapter’’.
MD 20993–0002. ‘‘Center for Biologics Evaluation and ■ b. In paragraph (b)(3)(iv) by removing
Research (HFM–407) (see mailing the word ‘‘allergenic’’ and by adding in
PART 610—GENERAL BIOLOGICAL addresses in § 600.2 of this chapter)’’ its place the word ‘‘Allergenic’’ and by
PRODUCTS STANDARDS and by adding in their place ‘‘Food and removing the words ‘‘addresses in
Drug Administration, Center for § 600.2’’ and by adding in their place
■ 45. The authority citation for 21 CFR Biologics Evaluation and Research, ‘‘address in § 600.2(a) of this chapter’’.
part 610 continues to read as follows: Reagents and Standards Shipping,
■ c. In paragraph (c) by removing the
10903 New Hampshire Ave., Bldg. 75,
Authority: 21 U.S.C. 321, 331, 351, 352, Rm. G704, Silver Spring, MD 20993– words ‘‘addresses in § 600.2’’ and by
353, 355, 360, 360c, 360d, 360h, 360i, 371, 0002’’. adding in their place ‘‘address in
372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, § 600.2(a) of this chapter’’.
264. § 660.36 [Amended]
PART 801—LABELING
§ 610.2 [Amended] ■ 53. Section 660.36 is amended as
follows:
■ 58. The authority citation for 21 CFR
■ 46. Section 610.2 is amended in the ■ a. In paragraph (a) introductory text by
part 801 continues to read as follows:
first sentence of paragraph (a) by removing the words ‘‘(ATTN: HFM–672)
removing ‘‘§ 600.2’’ and by adding in its (see mailing addresses in § 600.2 of this Authority: 21 U.S.C. 321, 331, 351, 352,
place ‘‘§ 600.2(c)’’ and in the first chapter)’’ and by adding in their place 360i, 360j, 371, 374.
sentence of paragraph (b) by removing ‘‘(see mailing addresses in § 600.2(c) of § 801.55 [Amended]
‘‘§ 600.2’’ and by adding in its place this chapter)’’.
‘‘§ 600.2(c) of this chapter’’. ■ b. In paragraph (b) by adding the ■ 59. Section 801.55 is amended in
words ‘‘(see mailing addresses in paragraph (b)(1) by removing the words
§ 610.11 [Amended] § 600.2(a) of this chapter)’’ immediately ‘‘Office of Communication, Outreach
following the words ‘‘Director, Center and Development (HFM–40), Center for
■ 47. Section 610.11 is amended in the
for Biologics Evaluation and Research’’. Biologics Evaluation and Research,
first sentence of paragraph (g)(2) by
■ c. In paragraph (c) by adding the Food and Drug Administration, 1401
removing ‘‘§ 600.2’’ and by adding in its
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words ‘‘(see mailing addresses in Rockville Pike, Suite 200N, Rockville,
place ‘‘§ 600.2(a) or (b)’’. § 600.2(c) of this chapter)’’ immediately MD 20852–1448’’ and by adding in their
§ 610.15 [Amended] following the words ‘‘Director, Center place ‘‘Food and Drug Administration,
for Biologics Evaluation and Research’’. Center for Biologics Evaluation and
■ 48. Section 610.15 is amended in Research, Document Control Center,
paragraph (a)(3) by removing ‘‘§ 600.2’’ § 660.46 [Amended]
10903 New Hampshire Ave., Bldg. 71,
and by adding in its place ‘‘§ 600.2(a) or ■ 54. Section 660.46 is amended in Rm. G112, Silver Spring, MD 20993–
(b)’’. paragraph (a)(2) introductory text by 0002’’.

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18094 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations

PART 807—ESTABLISHMENT Center for Biologics Evaluation and Evaluation and Research, Document
REGISTRATION AND DEVICE LISTING Research, Food and Drug Control Center, 10903 New Hampshire
FOR MANUFACTURERS AND INITIAL Administration, 1401 Rockville Pike, Ave., Bldg. 71, Rm. G112, Silver Spring,
IMPORTERS OF DEVICES Suite 200N, Rockville, MD 20852–1448’’ MD 20993–0002, ATTN: Tissue
and by adding in their place ‘‘Food and Establishment Registration
■ 60. The authority citation for 21 CFR Drug Administration, Center for Coordinator’’.
part 807 continues to read as follows: Biologics Evaluation and Research, ■ b. In paragraph (b)(3) by removing
Authority: 21 U.S.C. 321, 331, 351, 352, Document Control Center, 10903 New ‘‘301–827–1800’’ and by adding in its
360, 360c, 360e, 360i, 360j, 371, 374, 381, Hampshire Ave., Bldg. 71, Rm. G112, place ‘‘240–402–8010’’.
393; 42 U.S.C. 264, 271. Silver Spring, MD 20993–0002’’. ■ c. In paragraph (c)(1) by removing the
words ‘‘Center for Biologics Evaluation
§ 807.90 [Amended] § 814.104 [Amended] and Research (HFM–775), Food and
■ 61. Section 807.90 is amended in ■ 66. Section 814.104 is amended in Drug Administration, 1401 Rockville
paragraph (a)(2) by removing in the first paragraph (d)(2) by removing the words Pike, Rockville, MD 20852–1448,
sentence the words ‘‘Document Control ‘‘Document Control Center (HFM–99), Attention: Tissue Establishment
Center (HFM–99), Center for Biologics Center for Biologics Evaluation and Registration Coordinator’’ and by adding
Evaluation and Research, Food and Research, Food and Drug in their place the words ‘‘Food and Drug
Drug Administration, 1401 Rockville Administration, 1401 Rockville Pike, Administration, Center for Biologics
Pike, Suite 200N, Rockville, MD 20852– Suite 200N, Rockville, MD 20852–1448’’ Evaluation and Research, Document
1448’’ and by adding in their place and by adding in their place ‘‘Food and Control Center, 10903 New Hampshire
‘‘Food and Drug Administration, Center Drug Administration, Center for Ave., Bldg. 71, Rm. G112, Silver Spring,
for Biologics Evaluation and Research, Biologics Evaluation and Research, MD 20993–0002, ATTN: Tissue
Document Control Center, 10903 New Document Control Center, 10903 New Establishment Registration
Hampshire Ave., Bldg. 71, Rm. G112, Hampshire Ave., Bldg. 71, Rm. G112, Coordinator’’.
Silver Spring, MD 20993–0002’’ and by Silver Spring, MD 20993–0002’’. ■ d. In paragraph (c)(2) by removing ‘‘at
removing in the second sentence ‘‘at http://www.fda.gov/cber/tissue/
http://www.fda.gov/cber/dap/ PART 822—POSTMARKET tisreg.htm’’ and by adding in its place
devlst.htm’’ and by adding in its place SURVEILLANCE the words ‘‘using the CBER electronic
‘‘by using the Center for Biologics Web-based application’’.
Evaluation and Research electronic ■ 67. The authority citation for 21 CFR
■ 71. Section 1271.37 is revised to read
Web-based application’’. part 822 continues to read as follows:
as follows:
Authority: 21 U.S.C. 331, 352, 360i, 360l,
PART 812—INVESTIGATIONAL 371, 374. § 1271.37 Will establishment registrations
DEVICE EXEMPTIONS and HCT/P listings be available for
§ 822.8 [Amended] inspection, and how do I request
■ 62. The authority citation for 21 CFR information on registrations and listings?
■ 68. Section 822.8 is amended by
part 812 continues to read as follows: (a) Any registration on Form FDA
removing the words ‘‘Document Control
Authority: 21 U.S.C. 331, 351, 352, 353, Center (HFM–99), Center for Biologics 3356 filed in paper or electronic format
355, 360, 360c-360f, 360h-360j, 371, 372, 374, Evaluation and Research, Food and by each establishment will be available
379e, 381, 382, 383; 42 U.S.C. 216, 241, 262, for public inspection through the Center
Drug Administration, 1401 Rockville
263b–263n. for Biologics Evaluation and Research
Pike, Suite 200N, Rockville, MD 20852–
§ 812.19 [Amended] 1448’’ and by adding in their place Human Cell and Tissue Establishment
■ 63. Section 812.19 is amended in ‘‘Food and Drug Administration, Center Registration—Public Query Web site by
paragraph (a)(2) by removing the words for Biologics Evaluation and Research, using the CBER electronic Web-based
‘‘Document Control Center (HFM–99), Document Control Center, 10903 New application or by going in person to the
Center for Biologics Evaluation and Hampshire Ave., Bldg. 71, Rm. G112, Food and Drug Administration, Division
Research, Food and Drug Silver Spring, MD 20993–0002’’. of Dockets Management Public Reading
Administration, 1401 Rockville Pike, Room (see address in § 20.120(a) of this
Suite 200N, Rockville, MD 20852–1448’’ PART 1271—HUMAN CELLS, TISSUES, chapter). The following information
and by adding in their place ‘‘Food and AND CELLULAR AND TISSUE–BASED submitted under the HCT/P
Drug Administration, Center for PRODUCTS requirements is illustrative of the type
Biologics Evaluation and Research, of information that will be available for
■ 69. The authority citation for 21 CFR public disclosure when it is compiled:
Document Control Center, 10903 New part 1271 continues to read as follows:
Hampshire Ave., Bldg. 71, Rm. G112, (1) A list of all HCT/P’s;
Silver Spring, MD 20993–0002’’. Authority: 42 U.S.C. 216, 243, 263a, 264, (2) A list of all HCT/P’s manufactured
271. by each establishment;
PART 814—PREMARKET APPROVAL (3) A list of all HCT/P’s discontinued;
§ 1271.22 [Amended] and
OF MEDICAL DEVICES
■ 70. Section 1271.22 is amended as (4) All data or information that has
■ 64. The authority citation for 21 CFR follows: already become a matter of public
part 814 continues to read as follows: ■ a. In paragraph (b)(1) by removing the record.
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Authority: 21 U.S.C. 351, 352, 353, 360, words ‘‘Center for Biologics Evaluation (b) You should direct your other
360c-360j, 371, 372, 373, 374, 375, 379, 379e, and Research (HFM–775), Food and requests for information regarding
381. Drug Administration, 1401 Rockville HCT/P establishment registrations and
Pike, Rockville, MD 20852–1448, HCT/P listings to the Food and Drug
§ 814.20 [Amended] Attention: Tissue Establishment Administration, Center for Biologics
■ 65. Section 814.20 is amended in Registration Coordinator’’ and by adding Evaluation and Research, Office of
paragraph (h)(2) by removing the words in their place ‘‘Food and Drug Communication, Outreach and
‘‘Document Control Center (HFM–99), Administration, Center for Biologics Development, 10903 New Hampshire

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Ave., Bldg. 71, Rm. 3103, Silver Spring, and HUD has not provided new 1995, HUD removed much of part 235
MD 20993–0002. mortgage subsidy payments under this from the CFR as part of HUD’s effort to
■ 72. Section 1271.350 is amended: program since then. Because the eliminate outdated, obsolete, or
■ a. In the first sentence of paragraph regulations governing this program are unutilized regulations, leaving only the
(a)(5) by removing the words ‘‘Center for no longer operative, they are being parts that were necessary to regulate
Biologics Evaluation and Research removed by this final rule. To the extent outstanding loans assisted or insured
(HFM–210), Food and Drug that any Section 235 mortgages remain under the program. (See 60 FR 56498.)
Administration, 1401 Rockville Pike, in existence, or second mortgages for the As of the date of this publication, there
Suite 200N, Rockville, MD 20852–1448’’ recapture of subsidy payment pursuant are only two outstanding loans
and by adding in their place ‘‘Food and to HUD’s regulations governing the
remaining that were assisted or insured
Drug Administration, Center for Section 235 Program (which was
under this program.
Biologics Evaluation and Research, reserved by regulatory streamlining in
Document Control Center, 10903 New 1995), the removal of these regulations This Final Rule
Hampshire Ave., Bldg. 71, Rm. G112, does not affect the requirements for
transactions entered into when Section Since authority for HUD to provide
Silver Spring, MD 20993–0002’’; and
■ b. By revising paragraph (b)(3) to read 235 Program regulations were in effect. assistance or insurance to low-income
as follows: Assistance made available under the borrowers under the Section 235
Section 235 Program will continue to be Homeownership Program expired on
§ 1271.350 Reporting. governed by the regulations that existed October 1, 1989, HUD is proceeding to
* * * * * immediately before the effective date of remove Section 235 Program regulations
(b) * * * this final rule. codified in 24 CFR part 235.
(3) You must report each such DATES: Effective May 4, 2015. Loans issued with assistance provided
HCT/P deviation that relates to a core FOR FURTHER INFORMATION CONTACT: under Section 235 that are still
CGTP requirement on Form FDA 3486 Camille E. Acevedo, Associate General outstanding will continue to be
within 45 days of the discovery of the Counsel for Legislation and Regulations, governed by the regulations in effect on
event either electronically using the Office of General Counsel, Department May 3, 2015. Accordingly, this rule
Center for Biologics Evaluation and of Housing and Urban Development,
Research electronic Web-based amends § 1301 (Expiring Programs—
451 7th Street SW., Room 10276,
application or by mail to the Food and Savings Clause) of 24 CFR 200, subpart
Washington, DC 20410; telephone 202–
Drug Administration, Center for 708–1793 (this is not a toll-free W (Administrative Matters), and adds a
Biologics Evaluation and Research, number). Persons with hearing or new paragraph (g) to § 200.1301, which
Document Control Center, 10903 New speech impairments may access this preserves the Section 235 Program
Hampshire Ave., Bldg. 71, Rm. G112, number through TTY by calling the toll- regulations as in effect prior to the
Silver Spring, MD 20993–0002. free Federal Relay Service at 800–877– effective date of this final rule, and
Dated: March 23, 2015. 8389. continues to govern any assistance
SUPPLEMENTARY INFORMATION: provided under the Section 235 Program
Leslie Kux,
before May 4, 2015.
Associate Commissioner for Policy. I. Background
[FR Doc. 2015–07268 Filed 4–2–15; 8:45 am] II. Justification for Final Rulemaking
On August 1, 1968, the Housing and
BILLING CODE 4164–01–P Urban Development Act of 1968 (Pub. L. HUD generally publishes a rule for
90–448) amended the National Housing public comment before issuing a final
Act to add a new section 235 (12 U.S.C. rule for effect, in accordance with
DEPARTMENT OF HOUSING AND 1715z) (Section 235 Program). This
URBAN DEVELOPMENT HUD’s own regulations on rulemaking
provision authorized the Secretary to in 24 CFR part 10. However, part 10
provide subsidies to reduce mortgage provides for exceptions to the general
24 CFR Parts 200 and 235 interest rates to as low as 1 percent and
rule if the agency finds good cause to
[Docket No. FR–5829–F–01] authorized a new credit assistance
omit advance notice and public
homeownership program for lower-
Federal Housing Administration (FHA): income families who were unable to participation. The good cause
Removal of Section 235 Home meet the credit requirements generally requirement is satisfied when prior
Ownership Program Regulations applicable to FHA mortgage insurance public procedure is impracticable,
programs. HUD promulgated regulations unnecessary, or contrary to the public
AGENCY: Office of the Assistant interest. (See 24 CFR 10.1.)
Secretary for Housing, Federal Housing implementing the Section 235 Program
Commissioner, HUD. on January 6, 1976 (see 41 FR 1176) and HUD finds that public notice and
codified these regulations in part 235 of comment are not necessary for this
ACTION: Final rule.
title 24 of the Code of Federal rulemaking because assistance is no
SUMMARY: Through this rule, HUD Regulations (CFR). However, on longer being provided under this
removes the regulations for its Section February 5, 1988, the Section 235 program and, therefore, the regulations
235 Program, which authorized HUD to Program was terminated under section are no longer operative. For these
provide mortgage subsidy payments to 401(d) of the Housing and Community reasons, HUD has determined that it is
asabaliauskas on DSK5VPTVN1PROD with RULES

lenders to assist lower-income families Development Act of 1987 (Pub. L. 100– unnecessary to delay the effectiveness of
who are unable to meet the credit 242) and HUD ceased to make mortgage this rule in order to solicit prior public
requirements generally applicable to subsidy payments available under this comment.
FHA mortgage insurance programs. program beginning October 1, 1989.1 In
Authority to provide insurance to 1 Although the Section 235 Program was insured previously under section 235(r) of the
mortgagees under this program was terminated, section 401(d) of the Housing and National Housing Act. However, no insurance or
terminated under the Housing and Community Development Act of 1987 permitted the assistance for new loans has been provided by HUD
Community Development Act of 1987 Secretary to continue to refinance mortgages since October 1, 1989.

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Document Created: 2015-12-18 15:29:07
Document Modified: 2015-12-18 15:29:07
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule; technical amendment.
Dates		This rule is effective April 3, 2015.
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.
FR Citation		80 FR 18087
CFR Citation		21 CFR 1271 21 CFR 1 21 CFR 201 21 CFR 203 21 CFR 206 21 CFR 207 21 CFR 26 21 CFR 310 21 CFR 312 21 CFR 314 21 CFR 600 21 CFR 601 21 CFR 606 21 CFR 607 21 CFR 610 21 CFR 660 21 CFR 680 21 CFR 801 21 CFR 807 21 CFR 812 21 CFR 814 21 CFR 822 21 CFR 99
CFR Associated		Cosmetics; Drugs; Exports; Food Labeling; Imports; Labeling; Reporting and Recordkeeping Requirements; Investigations; Medical Research; Safety; Confidential Business Information; Health Records; Human Cells and Tissue-Based Products; Prescription Drugs; Warehouses; Animal Drugs; Biologics; Blood; Laboratories; Administrative Practice and Procedure and Medical Devices
80 FR 18087 - Food and Drug Administration Regulations; Change of Addresses; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
