
[Federal Register Volume 79, Number 57 (Tuesday, March 25, 2014)]
[Notices]
[Pages 16344-16345]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0250]


Draft Guidance for Industry on Labeling for Human Prescription 
Drug and Biological Products Approved Under the Accelerated Approval 
Regulatory Pathway; 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availability of a draft guidance for industry entitled ``Labeling for 
Human Prescription Drug and Biological Products Approved Under the 
Accelerated Approval Regulatory Pathway.'' This draft guidance 
discusses FDA's recommendations for developing the indication and usage 
statements in the prescribing information for drugs approved under the 
accelerated approval regulatory pathway (hereafter ``accelerated 
approval''). The guidance also discusses labeling considerations for 
indications approved under accelerated approval when clinical benefit 
has been verified and FDA terminates the conditions of accelerated 
approval, or when FDA withdraws accelerated approval of an indication 
while other indications for the drug remain approved.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 27, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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,

[[Page 16345]]

Silver Spring, MD 20993-0002, or 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. Send one self-addressed adhesive label to 
assist that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Ann Marie Trentacosti, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6485, Silver Spring, MD 20993-0002, 301-
796-2901; or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
Suite 200N, Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Labeling for Human Prescription Drug and Biological Products 
Approved Under the Accelerated Approval Regulatory Pathway.'' Labeling 
must conform to the content and format requirements delineated in 
Sec. Sec.  201.56(d) and 201.57 (21 CFR 201.56(d) and 201.57). Special 
provisions exist for older drug labeling under Sec. Sec.  201.56(e) and 
201.80. Labeling for drugs approved under the accelerated approval 
process is fundamentally the same as for drugs approved under the 
traditional pathway; however, for drugs approved under accelerated 
approval there are additional labeling requirements as described in 
Sec.  201.57(c)(2)(i)(B) and recommended elements for consideration.
    This draft guidance discusses FDA's recommendations for developing 
the indication and usage statements in the prescribing information for 
drugs approved under accelerated approval as defined in 21 CFR part 
314, subpart H (for new drug applications) and 21 CFR part 601, subpart 
E (for biologics license applications) when the approval is based on an 
effect on a surrogate endpoint that is reasonably likely to predict 
clinical benefit, or an effect on a clinical endpoint that can be 
measured earlier than an effect on irreversible morbidity or mortality, 
that is reasonably likely to predict an effect on irreversible 
morbidity or mortality or other clinical benefit. The guidance also 
discusses labeling considerations for indications approved under 
accelerated approval when clinical benefit has been verified and FDA 
terminates the conditions of accelerated approval under 21 CFR 314.560 
or 21 CFR 601.46, or when FDA withdraws accelerated approval of an 
indication while other indications for the drug remain approved.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on labeling for 
human prescription drug and biologic products approved under 
accelerated approval. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in Sec. Sec.  201.56 and 201.57 
have been approved under OMB control number 0910-0572.

III. 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.

IV. Electronic Access

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

    Dated: March 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06471 Filed 3-24-14; 8:45 am]
BILLING CODE 4160-01-P


