
[Federal Register Volume 84, Number 23 (Monday, February 4, 2019)]
[Notices]
[Pages 1470-1471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00894]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Labeling for Human Prescription Drug and Biological Products 
Approved Under the Accelerated Approval Regulatory Pathway; Guidance 
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Labeling 
for Human Prescription Drug and Biological Products Approved Under the 
Accelerated Approval Regulatory Pathway.'' This 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. This guidance 
finalizes the draft guidance of the same name issued March 25, 2014.

DATES: The announcement of the guidance is published in the Federal 
Register on February 4, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-D-0250 for ``Labeling for Human Prescription Drug and 
Biological Products Approved Under the Accelerated Approval Regulatory 
Pathway; Guidance for Industry; Availability.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002, or Office of 
Communication, Outreach, and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. 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.

FOR FURTHER INFORMATION CONTACT: John Gallagher, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6473, Silver Spring, MD 20993-0002, 240-
402-4768; or

[[Page 1471]]

Stephen Ripley, 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:

I. Background

    FDA is announcing the availability of a final 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.  201.57(d) and 201.57 (21 CFR 201.56(d) and 201.57). 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 
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), specifically 21 CFR 314.510 and 21 CFR 
601.41. 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 guidance finalizes the draft guidance of the same name issued 
March 25, 2014 (79 FR 16344). Changes from the draft guidance include 
the recommendations regarding how to fulfill the regulatory requirement 
that the labeling for drugs approved under accelerated approval include 
a succinct description of the limitations of usefulness of the drug and 
any uncertainty about clinical benefits. The draft guidance proposed 
recommending inclusion of a statement in the indication describing the 
specific clinical benefit that remains to be established; the final 
guidance states that simply reporting the endpoint used, without this 
additional statement, may be sufficient, except in certain 
circumstances when additional context about the approval should be 
included.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on labeling for human prescription drug and 
biological products approved under accelerated approval. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. This guidance 
is not subject to Executive Order 12866.

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. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: January 16, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00894 Filed 2-1-19; 8:45 am]
 BILLING CODE 4164-01-P


