
[Federal Register Volume 78, Number 146 (Tuesday, July 30, 2013)]
[Notices]
[Pages 45930-45931]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18236]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0164]


Guidance for Industry: Safety Labeling Changes--Implementation of 
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Safety Labeling 
Changes--Implementation of Section 505(o)(4) of the FD&C Act.'' The 
Food and Drug Administration Amendments Act of 2007 (FDAAA) added new 
provisions to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
authorizing FDA to require certain drug and biological product 
application holders to make safety-related labeling changes based upon 
new safety information that becomes available after the drug or 
biological product is approved under the FD&C Act or the Public Health 
Service Act (the PHS Act). This final guidance provides information on 
the implementation of section 505(o)(4) of the FD&C Act, including a 
description of the types of safety labeling changes that ordinarily 
might be required under this section; how FDA plans to determine what 
constitutes new safety information; the procedures involved in 
requiring safety labeling changes; and enforcement of the requirements 
for safety labeling changes.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 2201, Silver Spring, MD 20993-0002; or the Office of 
Communication, Outreach and Development (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448. The guidance may also be 
obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kristen Everett, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 301-
796-0453; or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Safety Labeling Changes--Implementation of Section 505(o)(4) 
of the FD&C Act.'' In the past, FDA has requested that holders of 
applications for approved products make labeling changes related to 
safety after approval to address serious risks. In most cases, 
application holders responded to these requests by negotiating 
appropriate language with FDA staff to address the concerns and then 
submitting a supplement or amended supplement to obtain approval of the 
change. However, negotiations were often protracted, and FDA had few 
tools available at its disposal to end negotiations and require the 
changes. Congress recognized the limitations of FDA's authority in this 
area and, in FDAAA, gave FDA new authorities to require safety labeling 
changes in certain circumstances.
    Title IX, section 901 of FDAAA (Pub. L. 110-85) amended the FD&C 
Act by adding new section 505(o)(4) (21 U.S.C. 355(o)(4)). Section 
505(o)(4) authorizes FDA to require, and if necessary, order labeling 
changes if FDA becomes aware of new safety information that FDA 
believes should be included in the labeling of certain prescription 
drug and biological products approved under section 505 of the FD&C Act 
or section 351 of the PHS Act (42 U.S.C. 262). Specifically, section 
505(o)(4) of the FD&C Act applies to prescription drug products with an 
approved new drug application (NDA) under section 505(b) of the FD&C 
Act, biological products with an approved biologics license application 
(BLA) under section 351 of the PHS Act, or prescription drug products 
with an approved abbreviated new drug application (ANDA) under section 
505(j) of the FD&C Act if the NDA reference listed drug is not 
currently marketed. The safety labeling changes provisions in section 
505(o)(4) apply to the previously listed products, including products 
that are not marketed, unless approval of the NDA, BLA, or ANDA has 
been withdrawn in the Federal Register. FDAAA imposes timeframes for 
application holders to submit and FDA staff to review safety labeling 
changes, and gives FDA new enforcement tools to bring about timely and 
appropriate labeling changes.
    In the Federal Register of April 13, 2011 (76 FR 20686), FDA 
announced the availability of a draft guidance for industry entitled 
``Safety Labeling Changes--Implementation of Section 505(o)(4) of the 
Federal Food, Drug, and Cosmetic Act.'' The notice gave interested 
parties the opportunity to comment by July 12, 2011. FDA carefully 
considered all of the comments received, and revised the guidance as 
appropriate. This guidance is intended to clarify how FDA will 
implement section 505(o)(4) of the FD&C Act, including providing a 
description of the types of safety labeling changes that ordinarily 
might be required under this section; how FDA plans to determine what

[[Page 45931]]

constitutes new safety information; what procedures are involved in 
requiring safety labeling changes; and how FDA will enforce the 
requirements for safety labeling changes.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on implementation of section 505(o)(4) of the 
FD&C Act. It does not create or confer any rights for or on any person 
and does not operate to bind FDA or the public. An alternative approach 
may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    This guidance contains collections of information that are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The 
collections of information have been approved under OMB control number 
0910-0734. This guidance also refers to previously approved collections 
of information. Specifically, the guidance describes: Labeling 
supplements for NDAs, ANDAs, and BLAs submitted under 21 CFR 314.70, 
314.71, 314.97, and 601.12; and the content and format of prescription 
drug labeling submitted under 21 CFR 201.56 and 201.57. These 
collections of information are subject to review by OMB under the PRA 
and are approved under OMB control numbers 0910-0001, 0910-0338, and 
0910-0572. Section V of the guidance refers to the guidance entitled 
``Formal Dispute Resolution: Appeals Above the Division Level,'' which 
describes collections of information approved under OMB control number 
0910-0430.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: July 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18236 Filed 7-29-13; 8:45 am]
BILLING CODE 4160-01-P


