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

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 crossreferences 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 § 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 twoway 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 


asabaliauskas on DSK5VPTVN1PROD with RULES
18088 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations 

blood components, as well as the 

address for requesting an opportunity 

for a hearing, are updated to the White 

Oak campus. 

• In § 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 § 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 § 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 § 600.11(f)(6), the cross-reference 

‘‘§ 600.2’’ is changed to ‘‘§ 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 § 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 § 600.22(e), the cross-reference 

‘‘§ 600.2’’ is changed to ‘‘§ 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 § 601.2(a), the cross-reference 

‘‘§ 600.2’’ is changed to ‘‘§ 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 § 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 § 601.15, the cross-reference 

‘‘§ 600.2’’ is changed to ‘‘§ 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 § 601.28, the cross-reference 

‘‘§ 600.2’’ is changed to ‘‘§ 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 § 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 § 601.70(d), the cross-reference 

‘‘§ 600.2’’ is changed to ‘‘§ 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 § 606.170(b), the cross-reference 

‘‘§ 600.2’’ is changed to ‘‘§ 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 § 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 § 607.7(b) and (c), the crossreference ‘‘§ 600.2’’ is changed to 

‘‘§ 600.2(a)’’ and the reference to mail 

code ‘‘(HFM–375)’’ is removed to clarify 

using the updated CBER Document 

Control Center address in § 600.2(a) 

when requesting and submitting 

registration and product listing 

information with regard to the 

manufacture of blood products. 

• In § 607.22(a), the cross-reference 

‘‘§ 600.2’’ is changed to ‘‘§ 600.2(a)’’ and 

the reference to mail code ‘‘(HFM–375)’’ 

is removed to clarify using the updated 

CBER Document Control Center address 

in § 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 

§ 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 § 610.2(a) and (b), the crossreference ‘‘§ 600.2’’ is changed to 

‘‘§ 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 § 610.11(g)(2), the cross-reference 

‘‘§ 600.2’’ is changed to ‘‘§ 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 § 610.15(a)(3), the cross-reference 

‘‘§ 600.2’’ is changed to ‘‘§ 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 § 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 § 660.6(a)(2), the cross-reference 

‘‘§ 600.2’’ is changed to ‘‘§ 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 § 660.6(c) is corrected. 

• In § 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 § 660.36, the cross-reference to 

§ 600.2(c) is added to § 660.36(a) and (c), 

and the cross-reference to § 600.2(a) is 

added to § 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 § 660.46(a)(2), the cross-reference 

‘‘§ 600.2’’ is changed to ‘‘§ 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 § 660.52, the CBER unit and 

address for obtaining reference 

preparations for Reference Anti-Human 

Globulin are updated to CBER Reagents 


asabaliauskas on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations 18089 

and Standards Shipping and the White 

Oak campus. 

• In § 680.1(b)(2)(iii), (b)(3)(iv), and 

(c), the cross-reference ‘‘§ 600.2’’ is 

changed to ‘‘§ 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 

§ 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 § 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 § 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 § 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 § 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. 


asabaliauskas on DSK5VPTVN1PROD with RULES
18090 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations 

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 

■ 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. 

§ 1.101 [Amended] 

■ 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 

■ 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. 

■ 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 

■ 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. 

§ 99.201 [Amended] 

■ 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 

■ 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. 

§ 201.25 [Amended] 

■ 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)’’. 

§ 201.58 [Amended] 

■ 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 

■ 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. 

■ 11. Section 203.12 is revised to read 

as follows: 

§ 203.12 An appeal from an adverse 

decision by the district office. 

An appeal from an adverse decision 

by the district office involving insulincontaining 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. 

■ 12. Section 203.37 is amended by 

revising paragraph (e) to read as follows: 

§ 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 


asabaliauskas on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations 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. 

■ 13. Section 203.70 is amended by 

revising paragraph (b)(2) to read as 

follows: 

§ 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 

■ 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. 

§ 206.7 [Amended] 

■ 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 

■ 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. 

§ 207.7 [Amended] 

■ 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 

■ 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. 

§ 310.503 [Amended] 

■ 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 

■ 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. 

§ 312.140 [Amended] 

■ 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’’. 

§ 312.145 [Amended] 

■ 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’’. 

§ 312.310 [Amended] 

■ 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 

■ 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. 

■ 25. Section 314.440 is amended by 

revising paragraph (b) introductory text 

to read as follows: 

§ 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 

§ 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 

■ 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. 

§ 600.2 [Amended] 

■ 27. Section 600.2 is amended as 

follows: 

■ 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, 


asabaliauskas on DSK5VPTVN1PROD with RULES
18092 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations 

Rm. G112, Silver Spring, MD 20993– 

0002’’. 

■ 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 

■ 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’’. 

§ 600.11 [Amended] 

■ 28. Section 600.11 is amended in 

paragraph (f)(6) by removing ‘‘§ 600.2’’ 

and by adding in its place ‘‘§ 600.2(a) or 

(b)’’. 

■ 29. Section 600.14 is amended by 

revising paragraph (e)(1) to read as 

follows: 

§ 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 § 600.2(a)), or submit 

electronically using CBER’s electronic 

Web-based application. 

* * * * * 

§ 600.22 [Amended] 

■ 30. Section 600.22 is amended in 

paragraph (e) by removing ‘‘§ 600.2’’ and 

by adding in its place ‘‘§ 600.2(c)’’. 

PART 601—LICENSING 

■ 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). 

§ 601.2 [Amended] 

■ 32. Section 601.2 is amended in the 

first sentence of paragraph (a) by 

removing ‘‘§ 600.2’’ and by adding in its 

place ‘‘§ 600.2(a) or (b)’’. 

§ 601.12 [Amended] 

■ 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’’. 

§ 601.15 [Amended] 

■ 34. Section 601.15 is amended by 

removing ‘‘§ 600.2’’ in both places it 

appears and by adding in each place 

‘‘§ 600.2(c)’’. 

§ 601.28 [Amended] 

■ 35. The introductory text of § 601.28 

is amended by removing ‘‘§ 600.2’’ and 

by adding in its place ‘‘§ 600.2(a) or (b)’’. 

§ 601.29 [Amended] 

■ 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 § 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’’. 

§ 601.70 [Amended] 

■ 37. Section 601.70 is amended in 

paragraph (d) by removing ‘‘§ 600.2’’ 

and by adding in its place ‘‘§ 600.2(a) or 

(b)’’. 

PART 606—CURRENT GOOD 

MANUFACTURING PRACTICE FOR 

BLOOD AND BLOOD COMPONENTS 

■ 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. 

§ 606.170 [Amended] 

■ 39. Section 606.170 is amended in the 

last sentence of paragraph (b) by 

removing the words ‘‘(for mailing 

addresses, see § 600.2 of this chapter)’’ 

and by adding in their place ‘‘(for 

mailing address, see § 600.2(a) of this 

chapter)’’. 

■ 40. Section 606.171 is amended by 

revising paragraph (e) to read as follows: 

§ 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 § 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 

■ 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. 

§ 607.7 [Amended] 

■ 42. Section 607.7 is amended in 

paragraphs (b) and (c) by removing both 

times it appears ‘‘(HFM–375) (see 

mailing addresses in § 600.2 of this 

chapter)’’ and by adding in their place 

‘‘(see mailing address in § 600.2(a) of 

this chapter)’’. 

§ 607.22 [Amended] 

■ 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 

§ 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 § 600.2(a) of this chapter),’’. 

■ 44. Section 607.37 is revised to read 

as follows: 

§ 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 


asabaliauskas on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations 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 § 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 

■ 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. 

§ 610.2 [Amended] 

■ 46. Section 610.2 is amended in the 

first sentence of paragraph (a) by 

removing ‘‘§ 600.2’’ and by adding in its 

place ‘‘§ 600.2(c)’’ and in the first 

sentence of paragraph (b) by removing 

‘‘§ 600.2’’ and by adding in its place 

‘‘§ 600.2(c) of this chapter’’. 

§ 610.11 [Amended] 

■ 47. Section 610.11 is amended in the 

first sentence of paragraph (g)(2) by 

removing ‘‘§ 600.2’’ and by adding in its 

place ‘‘§ 600.2(a) or (b)’’. 

§ 610.15 [Amended] 

■ 48. Section 610.15 is amended in 

paragraph (a)(3) by removing ‘‘§ 600.2’’ 

and by adding in its place ‘‘§ 600.2(a) or 

(b)’’. 

PART 660—ADDITIONAL STANDARDS 

FOR DIAGNOSTIC SUBSTANCES FOR 

LABORATORY TESTS 

■ 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. 

§ 660.3 [Amended] 

■ 50. Section 660.3 is amended by 

removing the words ‘‘Center for 

Biologics Evaluation and Research 

(HFM–407) (see mailing addresses in 

§ 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’’. 

§ 660.6 [Amended] 

■ 51. Section 660.6 is amended in 

paragraph (a)(2) by removing ‘‘§ 600.2’’ 

and by adding in its place ‘‘§ 600.2(c)’’ 

and in the heading of paragraph (c) by 

removing the word ‘‘Offical’’ and by 

adding in its place ‘‘Official’’. 

§ 660.22 [Amended] 

■ 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 § 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’’. 

§ 660.36 [Amended] 

■ 53. Section 660.36 is amended as 

follows: 

■ a. In paragraph (a) introductory text by 

removing the words ‘‘(ATTN: HFM–672) 

(see mailing addresses in § 600.2 of this 

chapter)’’ and by adding in their place 

‘‘(see mailing addresses in § 600.2(c) of 

this chapter)’’. 

■ b. In paragraph (b) by adding the 

words ‘‘(see mailing addresses in 

§ 600.2(a) of this chapter)’’ immediately 

following the words ‘‘Director, Center 

for Biologics Evaluation and Research’’. 

■ c. In paragraph (c) by adding the 

words ‘‘(see mailing addresses in 

§ 600.2(c) of this chapter)’’ immediately 

following the words ‘‘Director, Center 

for Biologics Evaluation and Research’’. 

§ 660.46 [Amended] 

■ 54. Section 660.46 is amended in 

paragraph (a)(2) introductory text by 

removing ‘‘§ 600.2’’ and by adding in its 

place ‘‘§ 600.2(c)’’. 

§ 660.52 [Amended] 

■ 55. Section 660.52 is amended by 

removing the words ‘‘Center for 

Biologics Evaluation and Research 

(HFM–407) (see mailing addresses in 

§ 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 

■ 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. 

§ 680.1 [Amended] 

■ 57. Section 680.1 is amended as 

follows: 

■ a. In the last sentence of paragraph 

(b)(2)(iii) by removing the words 

‘‘addresses in § 600.2’’ and by adding in 

their place ‘‘address in § 600.2(a) of this 

chapter’’. 

■ 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 

§ 600.2’’ and by adding in their place 

‘‘address in § 600.2(a) of this chapter’’. 

■ c. In paragraph (c) by removing the 

words ‘‘addresses in § 600.2’’ and by 

adding in their place ‘‘address in 

§ 600.2(a) of this chapter’’. 

PART 801—LABELING 

■ 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. 

§ 801.55 [Amended] 

■ 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’’. 


asabaliauskas on DSK5VPTVN1PROD with RULES
18094 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations 

PART 807—ESTABLISHMENT 

REGISTRATION AND DEVICE LISTING 

FOR MANUFACTURERS AND INITIAL 

IMPORTERS OF DEVICES 

■ 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. 

§ 807.90 [Amended] 

■ 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 

■ 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. 

§ 812.19 [Amended] 

■ 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 

■ 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. 

§ 814.20 [Amended] 

■ 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’’. 

§ 814.104 [Amended] 

■ 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 

■ 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. 

§ 822.8 [Amended] 

■ 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 

■ 69. The authority citation for 21 CFR 

part 1271 continues to read as follows: 

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

271. 

§ 1271.22 [Amended] 

■ 70. Section 1271.22 is amended as 

follows: 

■ 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’’. 

■ b. In paragraph (b)(3) by removing 

‘‘301–827–1800’’ and by adding in its 

place ‘‘240–402–8010’’. 

■ 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’’. 

■ 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’’. 

■ 71. Section 1271.37 is revised to read 

as follows: 

§ 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 § 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 


asabaliauskas on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations 18095 

1Although the Section 235 Program was 

terminated, section 401(d) of the Housing and 

Community Development Act of 1987 permitted the 

Secretary to continue to refinance mortgages 

insured previously under section 235(r) of the 

National Housing Act. However, no insurance or 

assistance for new loans has been provided by HUD 

since October 1, 1989. 

Ave., Bldg. 71, Rm. 3103, Silver Spring, 

MD 20993–0002. 

■ 72. Section 1271.350 is amended: 

■ 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 

■ b. By revising paragraph (b)(3) to read 

as follows: 

§ 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 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

24 CFR Parts 200 and 235 

[Docket No. FR–5829–F–01] 

Federal Housing Administration (FHA): 

Removal of Section 235 Home 

Ownership Program Regulations 

AGENCY: Office of the Assistant 

Secretary for Housing, Federal Housing 

Commissioner, HUD. 

ACTION: Final rule. 

SUMMARY: Through this rule, HUD 

removes the regulations for its Section 

235 Program, which authorized HUD to 

provide mortgage subsidy payments to 

lenders to assist lower-income families 

who are unable to meet the credit 

requirements generally applicable to 

FHA mortgage insurance programs. 

Authority to provide insurance to 

mortgagees under this program was 

terminated under the Housing and 

Community Development Act of 1987 

and HUD has not provided new 

mortgage subsidy payments under this 

program since then. Because the 

regulations governing this program are 

no longer operative, they are being 

removed by this final rule. To the extent 

that any Section 235 mortgages remain 

in existence, or second mortgages for the 

recapture of subsidy payment pursuant 

to HUD’s regulations governing the 

Section 235 Program (which was 

reserved by regulatory streamlining in 

1995), the removal of these regulations 

does not affect the requirements for 

transactions entered into when Section 

235 Program regulations were in effect. 

Assistance made available under the 

Section 235 Program will continue to be 

governed by the regulations that existed 

immediately before the effective date of 

this final rule. 

DATES: Effective May 4, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Camille E. Acevedo, Associate General 

Counsel for Legislation and Regulations, 

Office of General Counsel, Department 

of Housing and Urban Development, 

451 7th Street SW., Room 10276, 

Washington, DC 20410; telephone 202– 

708–1793 (this is not a toll-free 

number). Persons with hearing or 

speech impairments may access this 

number through TTY by calling the tollfree Federal Relay Service at 800–877– 

8389. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On August 1, 1968, the Housing and 

Urban Development Act of 1968 (Pub. L. 

90–448) amended the National Housing 

Act to add a new section 235 (12 U.S.C. 

1715z) (Section 235 Program). This 

provision authorized the Secretary to 

provide subsidies to reduce mortgage 

interest rates to as low as 1 percent and 

authorized a new credit assistance 

homeownership program for lowerincome families who were unable to 

meet the credit requirements generally 

applicable to FHA mortgage insurance 

programs. HUD promulgated regulations 

implementing the Section 235 Program 

on January 6, 1976 (see 41 FR 1176) and 

codified these regulations in part 235 of 

title 24 of the Code of Federal 

Regulations (CFR). However, on 

February 5, 1988, the Section 235 

Program was terminated under section 

401(d) of the Housing and Community 

Development Act of 1987 (Pub. L. 100– 

242) and HUD ceased to make mortgage 

subsidy payments available under this 

program beginning October 1, 1989.1 In 

1995, HUD removed much of part 235 

from the CFR as part of HUD’s effort to 

eliminate outdated, obsolete, or 

unutilized regulations, leaving only the 

parts that were necessary to regulate 

outstanding loans assisted or insured 

under the program. (See 60 FR 56498.) 

As of the date of this publication, there 

are only two outstanding loans 

remaining that were assisted or insured 

under this program. 

This Final Rule 

Since authority for HUD to provide 

assistance or insurance to low-income 

borrowers under the Section 235 

Homeownership Program expired on 

October 1, 1989, HUD is proceeding to 

remove Section 235 Program regulations 

codified in 24 CFR part 235. 

Loans issued with assistance provided 

under Section 235 that are still 

outstanding will continue to be 

governed by the regulations in effect on 

May 3, 2015. Accordingly, this rule 

amends § 1301 (Expiring Programs— 

Savings Clause) of 24 CFR 200, subpart 

W (Administrative Matters), and adds a 

new paragraph (g) to § 200.1301, which 

preserves the Section 235 Program 

regulations as in effect prior to the 

effective date of this final rule, and 

continues to govern any assistance 

provided under the Section 235 Program 

before May 4, 2015. 

II. Justification for Final Rulemaking 

HUD generally publishes a rule for 

public comment before issuing a final 

rule for effect, in accordance with 

HUD’s own regulations on rulemaking 

in 24 CFR part 10. However, part 10 

provides for exceptions to the general 

rule if the agency finds good cause to 

omit advance notice and public 

participation. The good cause 

requirement is satisfied when prior 

public procedure is impracticable, 

unnecessary, or contrary to the public 

interest. (See 24 CFR 10.1.) 

HUD finds that public notice and 

comment are not necessary for this 

rulemaking because assistance is no 

longer being provided under this 

program and, therefore, the regulations 

are no longer operative. For these 

reasons, HUD has determined that it is 

unnecessary to delay the effectiveness of 

this rule in order to solicit prior public 

comment. 


asabaliauskas on DSK5VPTVN1PROD with RULES