[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the draft guidance issued in February 2012.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