81 FR 8509 - Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 33 (February 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 33 (February 19, 2016)
| Page Range | 8509-8511 | |
| FR Document | 2016-03462 |
[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)] [Notices] [Pages 8509-8511] From the Federal Register Online [www.thefederalregister.org] [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 This guidance finalizes the draft guidance issued in February 2012.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
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Æ SKYLA (levonorgestrel-releasing hearing session. The contact person will after approval (postapproval). FDA
intrauterine system) notify interested persons regarding their believes that selective safety data
Æ SYMBAX (fluoxetine request to speak by March 29, 2016. collection may be possible for some late-
hydrocholoride and olanzapine) Persons attending FDA’s advisory stage premarket and postapproval
Æ VYVANSE CAPSULES committee meetings are advised that the clinical investigations because certain
(lisdexamfetamine dimesylate) Agency is not responsible for providing aspects of a drug’s safety profile will be
Æ XELODA (capecitabine) access to electrical outlets. sufficiently well-established and
• Center for Devices and Radiological FDA welcomes the attendance of the comprehensive data collection is not
Health (CDRH): public at its advisory committee needed. This guidance finalizes the
Æ IMPELLA RP SYSTEM meetings and will make every effort to draft guidance issued in February 2012.
(humanitarian use device (HUD)) accommodate persons with disabilities. DATES: Submit either electronic or
Æ LIPSORBER LA-15 SYSTEM (HUD) If you require accommodations due to a written comments on Agency guidances
Æ MEDTRONIC ACTIVA DYSTONIA disability, please contact Marieann Brill at any time.
THERAPY (HUD) at least 7 days in advance of the
meeting. ADDRESSES: You may submit comments
In addition to the agenda items, the as follows:
FDA is committed to the orderly
PAC will remain in public session over
conduct of its advisory committee Electronic Submissions
the lunch hour on April 12, 2016, to
meetings. Please visit our Web site at
hear a presentation and provide Submit electronic comments in the
http://www.fda.gov/
feedback on an FDA proposal for a risk- following way:
AdvisoryCommittees/
based approach to the pediatric-focused
AboutAdvisoryCommittees/ • Federal eRulemaking Portal: http://
safety reviews mandated by the Best www.regulations.gov. Follow the
ucm111462.htm for procedures on
Pharmaceuticals for Children Act and instructions for submitting comments.
public conduct during advisory
the Pediatric Research Equity Act. The Comments submitted electronically,
committee meetings.
working lunch currently is scheduled Notice of this meeting is given under including attachments, to http://
between approximately 12:30 p.m. and the Federal Advisory Committee Act (5 www.regulations.gov will be posted to
1:15 p.m. U.S.C. app. 2). the docket unchanged. Because your
FDA intends to make background comment will be made public, you are
material available to the public no later Dated: February 16, 2016.
solely responsible for ensuring that your
than 2 business days before the meeting. Jill Hartzler Warner, comment does not include any
If FDA is unable to post the background Associate Commissioner for Special Medical confidential information that you or a
material on its Web site prior to the Programs. third party may not wish to be posted,
meeting, the background material will [FR Doc. 2016–03469 Filed 2–18–16; 8:45 am] such as medical information, your or
be made publicly available at the BILLING CODE 4164–01–P anyone else’s Social Security number, or
location of the advisory committee confidential business information, such
meeting, and the background material as a manufacturing process. Please note
will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND that if you include your name, contact
the meeting. Background material is HUMAN SERVICES information, or other information that
available at http://www.fda.gov/ identifies you in the body of your
Food and Drug Administration
AdvisoryCommittees/Calendar/ comments, that information will be
default.htm. Scroll down to the [Docket No. FDA–2012–D–0096] posted on http://www.regulations.gov.
appropriate advisory committee meeting • If you want to submit a comment
link. Determining the Extent of Safety Data with confidential information that you
Procedure: Interested persons may Collection Needed in Late-Stage do not wish to be made available to the
present data, information, or views, Premarket and Postapproval Clinical public, submit the comment as a
orally or in writing, on issues pending Investigations; Guidance for Industry; written/paper submission and in the
before the committee. Written Availability manner detailed (see ‘‘Written/Paper
submissions may be made to the contact AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’).
person on or before April 5, 2016. Oral HHS.
presentations from the public will be Written/Paper Submissions
ACTION: Notice of availability.
scheduled between approximately 9:30 Submit written/paper submissions as
a.m. and 10:30 a.m. Those individuals SUMMARY: The Food and Drug follows:
interested in making formal oral Administration (FDA or Agency) is • Mail/Hand delivery/Courier (for
presentations should notify the contact announcing the availability of a written/paper submissions): Division of
person and submit a brief statement of guidance for industry entitled Dockets Management (HFA–305), Food
the general nature of the evidence or ‘‘Determining the Extent of Safety Data and Drug Administration, 5630 Fishers
arguments they wish to present, the Collection Needed in Late-Stage Lane, Rm. 1061, Rockville, MD 20852.
names and addresses of proposed Premarket and Postapproval Clinical • For written/paper comments
participants, and an indication of the Investigations.’’ The guidance is submitted to the Division of Dockets
approximate time requested to make intended to help sponsors determine the Management, FDA will post your
their presentation on or before March amounts and types of safety data to comment, as well as any attachments,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
28, 2016. Time allotted for each collect in late-stage premarket and except for information submitted,
presentation may be limited. If the postapproval clinical investigations marked and identified, as confidential,
number of registrants requesting to based on what is already known about if submitted as detailed in
speak is greater than can be reasonably a drug’s safety profile. Sponsors collect ‘‘Instructions.’’
accommodated during the scheduled extensive safety data in clinical Instructions: All submissions received
open public hearing session, FDA may investigations of drug and biological must include the Docket No. FDA–
conduct a lottery to determine the products conducted to support 2012–D–0096 for ‘‘Determining the
speakers for the scheduled open public marketing approval (premarket) and Extent of Safety Data Collection Needed
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III. Electronic Access Electronic Submissions comments only as a written/paper
Submit electronic comments in the submission. You should submit two
Persons with access to the Internet
following way: copies total. One copy will include the
may obtain the document at http://
• Federal eRulemaking Portal: http:// information you claim to be confidential
www.fda.gov/Drugs/Guidance
www.regulations.gov. Follow the with a heading or cover note that states
ComplianceRegulatoryInformation/
instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS
Guidances/default.htm, http:// CONFIDENTIAL INFORMATION’’. The
www.fda.gov/BiologicsBloodVaccines/ Comments submitted electronically,
including attachments, to http:// Agency will review this copy, including
GuidanceComplianceRegulatory the claimed confidential information, in
Information/Guidances/default.htm, or www.regulations.gov will be posted to
its consideration of comments. The
http://www.regulations.gov. the docket unchanged. Because your
second copy, which will have the
Dated: February 16, 2016.
comment will be made public, you are
claimed confidential information
solely responsible for ensuring that your
Leslie Kux, redacted/blacked out, will be available
comment does not include any
Associate Commissioner for Policy. for public viewing and posted on http://
confidential information that you or a
[FR Doc. 2016–03462 Filed 2–18–16; 8:45 am] www.regulations.gov. Submit both
third party may not wish to be posted,
copies to the Division of Dockets
BILLING CODE 4164–01–P such as medical information, your or
Management. If you do not wish your
anyone else’s Social Security number, or
name and contact information to be
confidential business information, such
DEPARTMENT OF HEALTH AND made publicly available, you can
as a manufacturing process. Please note
HUMAN SERVICES provide this information on the cover
that if you include your name, contact
sheet and not in the body of your
information, or other information that
Food and Drug Administration comments and you must identify this
identifies you in the body of your
information as ‘‘confidential.’’ Any
comments, that information will be
[Docket No. FDA–2013–N–0717] information marked as ‘‘confidential’’
posted on http://www.regulations.gov.
will not be disclosed except in
• If you want to submit a comment
Agency Information Collection accordance with 21 CFR 10.20 and other
with confidential information that you
Activities; Proposed Collection; applicable disclosure law. For more
do not wish to be made available to the
Comment Request; Evaluation of the information about FDA’s posting of
public, submit the comment as a
Food and Drug Administration’s comments to public dockets, see 80 FR
written/paper submission and in the
General Market Youth Tobacco 56469, September 18, 2015, or access
manner detailed (see ‘‘Written/Paper
Prevention Campaigns the information at: http://www.fda.gov/
Submissions’’ and ‘‘Instructions’’).
regulatoryinformation/dockets/
AGENCY: Food and Drug Administration, Written/Paper Submissions default.htm.
HHS. Docket: For access to the docket to
Submit written/paper submissions as
ACTION: Notice. read background documents or the
follows:
electronic and written/paper comments
SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for
received, go to http://
Administration (FDA) is announcing an written/paper submissions): Division of
www.regulations.gov and insert the
opportunity for public comment on the Dockets Management (HFA–305), Food
docket number, found in brackets in the
proposed collection of certain and Drug Administration, 5630 Fishers
heading of this document, into the
information by the Agency. Under the Lane, Rm. 1061, Rockville, MD 20852.
‘‘Search’’ box and follow the prompts
Paperwork Reduction Act of 1995 • For written/paper comments
and/or go to the Division of Dockets
(PRA), Federal Agencies are required to submitted to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
publish a notice in the Federal Register Management, FDA will post your
1061, Rockville, MD 20852.
concerning each proposed collection of comment, as well as any attachments,
except for information submitted, FOR FURTHER INFORMATION CONTACT: FDA
information, including each proposed PRA Staff, Office of Operations, Food
extension of an existing collection of marked and identified, as confidential,
if submitted as detailed in and Drug Administration, 8455
information, and to allow 60 days for Colesville Rd., COLE–14526, Silver
public comment in response to the ‘‘Instructions.’’
Instructions: All submissions received Spring, MD 20993–0002, PRAStaff@
notice. This notice solicits comments on fda.hhs.gov.
(1) an extension of the study conducted must include the Docket No. FDA–
2013–N–0717 for ‘‘Agency Information SUPPLEMENTARY INFORMATION: Under the
with the original longitudinal youth
cohort developed and surveyed for the Collection Activities; Proposed PRA (44 U.S.C. 3501–3520), Federal
outcome evaluation of FDA’s General Collection; Comment Request; Agencies must obtain approval from the
Market Youth Tobacco Prevention Evaluation of the Food and Drug Office of Management and Budget
Campaign, (2) the development of a Administration’s General Market Youth (OMB) for each collection of
second longitudinal cohort for the Tobacco Prevention Campaigns’’. information they conduct or sponsor.
purpose of continuing the evaluation, Received comments will be placed in ‘‘Collection of information’’ is defined
(3) an extension of the time period for the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR
the outcome evaluation of the Rural submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
Submissions,’’ publicly viewable at or requirements that members of the
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Male Youth Smokeless Tobacco
Campaign, (4) and an extension of the http://www.regulations.gov or at the public submit reports, keep records, or
media tracking survey. Division of Dockets Management provide information to a third party.
between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44
DATES: Submit either electronic or through Friday. U.S.C. 3506(c)(2)(A)) requires Federal
written comments on the collection of • Confidential Submissions—To Agencies to provide a 60-day notice in
information by April 19, 2016. submit a comment with confidential the Federal Register concerning each
ADDRESSES: You may submit comments information that you do not wish to be proposed collection of information,
as follows: made publicly available, submit your including each proposed extension of an
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Document Created: 2018-02-02 14:31:59
Document Modified: 2018-02-02 14:31:59
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| 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. | |
| FR Citation | 81 FR 8509 |
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