Federal Register / Vol. 78, No. 219 / Wednesday, November 13, 2013 / Proposed Rules 67985 

COMMODITY FUTURES TRADING 

COMMISSION 

17 CFR Part 170 

RIN 3038–AE09 

Membership in a Registered Futures 

Association 

Correction 

In proposed rule document 13–26790 

beginning on page 67078 in the issue of 

Friday, November 8, 2013, make the 

following correction: 

On page 67078, in the third column, 

under DATES, in the last line ‘‘January 

17, 2014’’ should read ‘‘January 7, 

2014’’. 

[FR Doc. C1–2013–26790 Filed 11–12–13; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 314 and 601 

[Docket No. FDA–2013–N–0500] 

RIN 0910–AG94 

Supplemental Applications Proposing 

Labeling Changes for Approved Drugs 

and Biological Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

proposing to amend its regulations to 

revise and clarify procedures for 

application holders of an approved drug 

or biological product to change the 

product labeling to reflect certain types 

of newly acquired information in 

advance of FDA’s review of the change. 

The proposed rule would create parity 

among application holders with respect 

to such labeling changes by permitting 

holders of abbreviated new drug 

applications (ANDAs) to distribute 

revised product labeling that differs in 

certain respects, on a temporary basis, 

from the labeling of its reference listed 

drug (RLD) upon submission to FDA of 

a ‘‘changes being effected’’ (CBE–0) 

supplement. The proposed rule 

describes the process by which 

information regarding a CBE–0 labeling 

supplement submitted by a new drug 

application (NDA) holder, an ANDA 

holder, or a biologics license application 

(BLA) holder would be made publicly 

available during FDA’s review of the 

labeling change and clarifies 

requirements for all ANDA holders to 

submit conforming labeling revisions 

after FDA has taken an action on the 

NDA or ANDA holder’s CBE–0 labeling 

supplement. The proposed rule also 

would amend the regulations to allow 

submission of a CBE–0 labeling 

supplement for certain changes to the 

‘‘Highlights of Prescribing Information’’ 

for drug products with labeling in the 

‘‘Physician Labeling Rule’’ (PLR) format. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by January 13, 2014. See section VII for 

the proposed effective date of a final 

rule based on this proposed rule. 

Submit comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 (the PRA) by 

December 13, 2013, (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2013–N– 

0500 and/or Regulatory Information 

Number (RIN) 0910–AG94, by any of the 

following methods, except that 

comments on information collection 

issues under the PRA must be submitted 

to the Office of Information and 

Regulatory Affairs, Office of 

Management and Budget (OMB) (see the 

‘‘Paperwork Reduction Act of 1995’’ 

section of this document). 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2013–N–0500 and RIN 

0910–AG94 for this rulemaking. All 

comments received may be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number(s), found in brackets in 

the heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Janice L. Weiner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6304, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

A. Drug Labeling 

B. Current Requirements Related to 

Changes to Approved Drug Labeling 

C. Specific Labeling Requirements Related 

to Generic Drugs 

D. Recent Court Decisions 

II. Description of the Proposed Rule 

A. Supplement Submission for SafetyRelated Labeling ‘‘Changes Being 

Effected’’ (Proposed §§ 314.70(b)(2), 

(c)(6), and (c)(8) and 601.12(f)(2)) 

B. Approval of Supplements to an 

Approved ANDA for a Labeling Change 

(Proposed § 314.97(b)) 

C. Exception for ANDA Labeling 

Differences Resulting From ‘‘Changes 

Being Effected’’ Supplement (Proposed 

§ 314.150(b)(10)(iii)) 

III. Legal Authority 

IV. Analysis of Impacts 

V. Paperwork Reduction Act of 1995 

VI. Environmental Impact 

VII. Effective Date 

VIII. Federalism 

IX. Request for Comments 

X. References 

Executive Summary 

Purpose of the Regulatory Action 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 301 et 

seq.) and the Public Health Service Act 

(the PHS Act) (42 U.S.C. 201 et seq.) 

provide FDA with authority over the 

labeling for drugs and biological 

products, and authorize the Agency to 

enact regulations to facilitate FDA’s 

review and approval of applications 

regarding the labeling for those 

products. FDA is proposing to amend its 

regulations to revise and clarify 

procedures for application holders to 

change the labeling of an approved drug 

or biological product to reflect certain 

types of newly acquired information in 

advance of FDA’s review of the change 

through a CBE–0 supplement. The 

proposed rule would create parity 

among application holders with respect 

to these safety-related labeling changes 

by permitting ANDA holders to 

distribute revised generic drug labeling 

that differs in certain respects, on a 

temporary basis, from the RLD labeling 

upon submission to FDA of a CBE–0 

supplement. 


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