Document ID: FDA-2012-D-0096-0013
Agency: fda
Document Type: Notice
Title: Determining the Extent of Safety Data Collection Needed in Late-Stage
Premarket and Postapproval Clinical Investigations; Guidance for Industry; Availability
Posted Date: 2016-02-19T05:00Z

[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8509-8511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03462]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0096]

Determining the Extent of Safety Data Collection Needed in Late-
Stage Premarket and Postapproval Clinical Investigations; 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 guidance for industry entitled ``Determining the 
Extent of Safety Data Collection Needed in Late-Stage Premarket and 
Postapproval Clinical Investigations.'' The guidance is intended to 
help sponsors determine the amounts and types of safety data to collect 
in late-stage premarket and postapproval clinical investigations based 
on what is already known about a drug's safety profile. Sponsors 
collect extensive safety data in clinical investigations of drug and 
biological products conducted to support marketing approval (premarket) 
and after approval (postapproval). FDA believes that selective safety 
data collection may be possible for some late-stage premarket and 
postapproval clinical investigations because certain aspects of a 
drug's safety profile will be sufficiently well-established and 
comprehensive data collection is not needed. This guidance finalizes 
the draft guidance issued in February 2012.

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

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2012-D-0096 for ``Determining the Extent of Safety Data Collection 
Needed

[[Page 8510]]

in Late-Stage Premarket and Postapproval Clinical Investigations; 
Guidance for Industry; Availability.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), 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 the office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Ebla Ali Ibrahim, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6302, Silver Spring, MD 20993-0002, 301-
796-3691; or 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 guidance for industry 
entitled ``Determining the Extent of Safety Data Collection Needed in 
Late-Stage Premarket and Postapproval Clinical Investigations.'' The 
guidance is intended to help sponsors determine the amounts and types 
of safety data to collect during late-stage premarket and postapproval 
clinical investigations (e.g., phase 3 clinical trials, studies of new 
uses, long-term outcomes) based on what is already known about a drug's 
safety profile.
    If the drug's safety profile is well-established before completion 
of clinical development or for marketed drugs used in postmarketing 
clinical trials, it may no longer be necessary in some cases to collect 
certain types of safety data. In some cases, collection of data that do 
not contribute to better characterizing the safety profile of a drug 
may have negative consequences. Additionally, excessive safety data 
collection practices may discourage the conduct of certain types of 
trials by increasing the resources needed to perform the trials and may 
also be a disincentive to investigator and patient participation in 
clinical trials. FDA believes that selective safety data collection 
may: (1) Facilitate the conduct of larger trials without compromising 
the integrity and the validity of trial results or losing important 
information, (2) facilitate investigators' and patients' participation 
in clinical trials, and (3) help contain costs by making more-efficient 
use of clinical trial resources.
    The guidance outlines the circumstances where selective data 
collection may be appropriate and the types of safety data that may be 
eligible for selective collection. The guidance provides 
recommendations on maintaining a balance between eliminating the 
collection of data that will not be useful and collecting sufficient 
data to allow adequate characterization of the safety profile of a drug 
in scenarios where selective safety data collection is appropriate. The 
guidance also strongly encourages sponsors to work closely with the 
relevant FDA review division or divisions to establish and implement 
selective safety data collection.
    In the Federal Register of February 10, 2012 (77 FR 7166), FDA 
announced the availability of a draft guidance for industry of the same 
title. The public comment period closed on April 10, 2012. FDA 
carefully considered all comments received in developing the guidance. 
In response to public comments requesting more detail and examples, the 
guidance was revised and reorganized to clarify what types of safety 
data and what circumstances may be appropriate for selective 
collection, add detail regarding the draft guidance topics, and provide 
additional information on safety data reporting issues. This guidance 
finalizes the draft guidance issued in February 2012.
    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 determining the extent of safety data 
collection needed in late-stage premarket and postapproval clinical 
investigations. 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.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 21 CFR 312.32 have been approved under 
OMB control number 0910-0014; the collections of information in 21 CFR 
312.47 have been approved under OMB control numbers 0910-0014 and 0910-
0429; the collections of information in 21 CFR 314.80 have been 
approved under OMB control number 0910-0230; and the collections of 
information in 21 CFR 600.80 have been approved under OMB control 
number 0910-0308.

[[Page 8511]]

III. 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: February 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03462 Filed 2-18-16; 8:45 am]
 BILLING CODE 4164-01-P