Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations; Guidance for Industry; Availability, 8509-8511 [2016-03462]

Download as PDF asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices Æ SKYLA (levonorgestrel-releasing intrauterine system) Æ SYMBAX (fluoxetine hydrocholoride and olanzapine) Æ VYVANSE CAPSULES (lisdexamfetamine dimesylate) Æ XELODA (capecitabine) • Center for Devices and Radiological Health (CDRH): Æ IMPELLA RP SYSTEM (humanitarian use device (HUD)) Æ LIPSORBER LA-15 SYSTEM (HUD) Æ MEDTRONIC ACTIVA DYSTONIA THERAPY (HUD) In addition to the agenda items, the PAC will remain in public session over the lunch hour on April 12, 2016, to hear a presentation and provide feedback on an FDA proposal for a riskbased approach to the pediatric-focused safety reviews mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. The working lunch currently is scheduled between approximately 12:30 p.m. and 1:15 p.m. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before April 5, 2016. Oral presentations from the public will be scheduled between approximately 9:30 a.m. and 10:30 a.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 28, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public VerDate Sep<11>2014 17:59 Feb 18, 2016 Jkt 238001 hearing session. The contact person will notify interested persons regarding their request to speak by March 29, 2016. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Marieann Brill at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 16, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016–03469 Filed 2–18–16; 8:45 am] BILLING CODE 4164–01–P 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: 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 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 after approval (postapproval). FDA believes that selective safety data collection may be possible for some latestage 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 Notice of availability. SUMMARY: 8509 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 E:\FR\FM\19FEN1.SGM 19FEN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES 8510 Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices 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 VerDate Sep<11>2014 17:59 Feb 18, 2016 Jkt 238001 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 wellestablished 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 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. E:\FR\FM\19FEN1.SGM 19FEN1 Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices III. Electronic Access Electronic Submissions Persons with access to the Internet may obtain the document at http:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm, or http://www.regulations.gov. 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’’). 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0717] Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Food and Drug Administration’s General Market Youth Tobacco Prevention Campaigns AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on (1) an extension of the study conducted with the original longitudinal youth cohort developed and surveyed for the outcome evaluation of FDA’s General Market Youth Tobacco Prevention Campaign, (2) the development of a second longitudinal cohort for the purpose of continuing the evaluation, (3) an extension of the time period for the outcome evaluation of the Rural Male Youth Smokeless Tobacco Campaign, (4) and an extension of the media tracking survey. DATES: Submit either electronic or written comments on the collection of information by April 19, 2016. ADDRESSES: You may submit comments as follows: asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:59 Feb 18, 2016 Jkt 238001 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– 2013–N–0717 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Food and Drug Administration’s General Market Youth Tobacco Prevention Campaigns’’. 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 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 8511 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. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an E:\FR\FM\19FEN1.SGM 19FEN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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