82 FR 37230 - Benefit-Risk Assessments in Drug Regulatory Decision-Making; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 152 (August 9, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 152 (August 9, 2017)
| Page Range | 37230-37232 | |
| FR Document | 2017-16720 |
[Federal Register Volume 82, Number 152 (Wednesday, August 9, 2017)] [Notices] [Pages 37230-37232] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16720] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4076] Benefit-Risk Assessments in Drug Regulatory Decision-Making; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing a public meeting to convene a discussion of topics related to the structured assessment of benefits and risks in drug regulatory decision-making. This meeting will focus on regulatory and industry experiences with approaches to structured benefit-risk assessments, approaches to incorporating patient perspectives into structured benefit-risk assessment, and exploration of methods to advance structured benefit-risk assessment. The format of the meeting will include a series of presentations on the above topics related to structured assessment of benefits and risks, followed by a discussion on those topics with invited panelists and audience members. This meeting satisfies an FDA commitment that is part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). DATES: The public meeting will be held on September 18, 2017, from 9 a.m. to 5 p.m. Registration to attend the meeting must be received by September 11, 2017 (see the SUPPLEMENTARY INFORMATION section for instructions). Public comments will be accepted through November 18, 2017. See the ADDRESSES section for information about submitting comments to the public docket. ADDRESSES: The public meeting will be held on September 18, 2017, at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center (the Great Room), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For more information on parking and security procedures, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 18, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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 [[Page 37231]] 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-2017-N-4076 for ``Benefit-Risk Assessments in Drug Regulatory Decision-Making; Public Meeting, Request for Comments.'' Received comments, those filed in a timely manner (see ADDRESSES), 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.thefederalregister.org/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. FDA will post the agenda approximately 5 days before the meeting at: https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm378861.htm. FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 301- 796-5003, FAX: 301-847-8443, [email protected]. SUPPLEMENTARY INFORMATION: I. Background On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144). Title I of FDASIA reauthorizes PDUFA V and provides FDA with the user fee resources necessary to maintain an efficient review process for human drug and biological products. The reauthorization of PDUFA V includes performance goals and procedures for the Agency that represents FDA's commitments during fiscal years 2013-2017. These commitments are fully described in the document entitled ``PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017'' (PDUFA Goals Letter), available on FDA's Web site at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf. Section X of the PDUFA Goals Letter, entitled ``Enhancing Benefit- Risk Assessment in Regulatory Decision-Making,'' includes development of a plan to further develop and implement a structured approach to benefit-risk assessment in the human drug review process. As part of this enhancement, FDA committed to holding two public workshops on benefit-risk considerations from the regulator's perspective that will begin by the first quarter of fiscal year 2014. The public workshop held in 2014 fulfilled the first of the two workshop commitments. The workshop announced by this notice will fulfill the second of the two workshop commitments. As part of its commitment, FDA has published the ``Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making: Draft PDUFA V Implementation Plan,'' available on FDA's Web site at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf. In this Plan, FDA identified as an area of further development the exploration of structured approaches to evaluate and communicate the assessment of benefits and risks. FDA's human drug regulatory decisions are informed by an extensive body of evidence on the safety and efficacy of a drug product, as well as other factors affecting the benefit-risk assessment, including the nature and severity of the condition the drug is intended to treat or prevent, the benefits and risks of other available therapies for the condition, and any risk management tools that might be necessary to ensure that the benefits outweigh the risks. A structured benefit-risk framework serves as a foundational element to FDA's benefit-risk assessments. II. Purpose and Scope of the Meeting This public meeting will focus on: (1) Regulatory and industry experiences with approaches to structured benefit-risk assessments, and the results of implementing structured frameworks at regulatory agencies both for premarket application review and postmarket safety review, (2) approaches to incorporating patient perspectives into structured benefit-risk assessment, and (3) exploration of methods to advance structured benefit-risk assessment. This meeting will be an opportunity to share any challenges and lessons learned in applying a more structured approach to regulatory decision-making. The public meeting will also explore more systematic and structured approaches to evaluate and communicate methods of assessing benefits and risks; and their implications on human drug regulatory decisions. Specifically, the workshop will examine FDA, other regulatory [[Page 37232]] agencies, industry, and external perspectives and experiences with structured benefit-risk assessment. This public meeting will have discussion sessions focusing on the entire drug development life cycle, including premarket drug review and postmarket safety surveillance. The format of the meeting consists of a series of presentations on topics related to structured assessment of benefits and risks, followed by a discussion on those topics with invited panelists and audience members. III. Meeting Attendance and Participation Registration: If you wish to attend this meeting, visit https://fdabenefitrisk.eventbrite.com. Please register by September 11, 2017. If you are unable to attend the meeting in person, you can register to view a live webcast of the meeting. You will be asked to indicate in your registration if you plan to attend in person or via the webcast. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations because of a disability, please contact Graham Thompson (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm378861.htm. Dated: August 3, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-16720 Filed 8-8-17; 8:45 am] BILLING CODE 4164-01-P
![37230 Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices
entitled ‘‘Expiration Dating of Unit-Dose guidance practices regulation (21 CFR risk assessments, approaches to
Repackaged Solid Oral Dosage Form 10.115). The revised draft guidance, incorporating patient perspectives into
Drug Products.’’ FDA’s current good when finalized, will represent the structured benefit-risk assessment, and
manufacturing practice (CGMP) current thinking of FDA on expiration exploration of methods to advance
regulations for finished pharmaceuticals dating of unit-dose repackaged solid structured benefit-risk assessment. The
require that each drug product bear an oral dosage form drug products. It does format of the meeting will include a
expiration date determined by not establish any rights for any person series of presentations on the above
appropriate stability testing and that the and is not binding on FDA or the public. topics related to structured assessment
date must be related to any storage You can use an alternative approach if of benefits and risks, followed by a
conditions stated on the labeling, as it satisfies the requirements of the discussion on those topics with invited
determined by stability studies (21 CFR applicable statutes and regulations. panelists and audience members. This
211.137(a) and (b)). Samples used for The current Compliance Policy Guide meeting satisfies an FDA commitment
stability testing must be in the same 480.200, ‘‘Expiration Dating of Unit- that is part of the fifth authorization of
container-closure system as that in Dose Repackaged Drugs,’’ issued the Prescription Drug User Fee Act
which the drug product is marketed (21 February 1, 1984, revised March 1995, (PDUFA V).
CFR 211.166(a)(4)). For unit-dose will be withdrawn when the revised DATES: The public meeting will be held
repackaged products, U.S. draft guidance is finalized. on September 18, 2017, from 9 a.m. to
Pharmacopeial Convention (USP) 5 p.m. Registration to attend the meeting
General Chapter <1178> recommends II. The Paperwork Reduction Act of
1995 must be received by September 11, 2017
that the expiration date ‘‘not exceed (1) (see the SUPPLEMENTARY INFORMATION
6 months from the date of repackaging; This revised draft guidance refers to
section for instructions). Public
or (2) the manufacturer’s expiration previously approved collections of
comments will be accepted through
date; or (3) 25% of the time between the information that are subject to review by
November 18, 2017. See the ADDRESSES
date of repackaging and the expiration the Office of Management and Budget
section for information about submitting
date shown on the manufacturer’s bulk (OMB) under the Paperwork Reduction
comments to the public docket.
article container of the drug being Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR ADDRESSES: The public meeting will be
repackaged, whichever is earlier.’’
For solid oral dosage forms parts 210 and 211 have been approved held on September 18, 2017, at the FDA
repackaged in unit-dose containers, the under OMB control number 0910–0139. White Oak Campus, 10903 New
revised draft guidance states that FDA Hampshire Ave., Bldg. 31 Conference
III. Electronic Access Center (the Great Room), Silver Spring,
does not intend to take action regarding
the requirements of §§ 211.137 and Persons with access to the internet MD 20993–0002. Entrance for the public
211.166 (i.e., expiration dating may obtain the draft guidance at either meeting participants (non-FDA
determined by stability studies) under http://www.fda.gov/Drugs/Guidance employees) is through Building 1 where
certain conditions. This revised draft ComplianceRegulatoryInformation/ routine security check procedures will
guidance describes these conditions. Guidances/default.htm or https:// be performed. For more information on
This draft guidance revises an earlier www.regulations.gov. parking and security procedures, please
draft guidance for industry, ‘‘Expiration refer to https://www.fda.gov/AboutFDA/
Dated: August 3, 2017.
Dating of Unit-Dose Repackaged Drugs: WorkingatFDA/BuildingsandFacilities/
Anna K. Abram,
Compliance Policy Guide.’’ Changes WhiteOakCampusInformation/
Deputy Commissioner for Policy, Planning, ucm241740.htm.
include the following: Legislation, and Analysis.
• Shortens the expiration date to be You may submit comments as
[FR Doc. 2017–16719 Filed 8–8–17; 8:45 am] follows. Please note that late, untimely
used under certain conditions for solid
BILLING CODE 4164–01–P filed comments will not be considered.
oral dosage forms repackaged in unit-
dose containers from 12 months to 6 Electronic comments must be submitted
months or 25 percent of the time on or before November 18, 2017. The
DEPARTMENT OF HEALTH AND https://www.regulations.gov electronic
remaining until the expiration date on HUMAN SERVICES
the container of the original filing system will accept comments
manufacturer’s product, whichever time Food and Drug Administration until midnight Eastern Time at the end
period is shorter. of November 18, 2017. Comments
• Provides for an expiration date [Docket No. FDA–2017–N–4076] received by mail/hand delivery/courier
exceeding 6 months if supportive data (for written/paper submissions) will be
Benefit-Risk Assessments in Drug considered timely if they are
from appropriate studies are available Regulatory Decision-Making; Public
and other conditions are met. postmarked or the delivery service
Meeting; Request for Comments
• Excludes from the scope of the acceptance receipt is on or before that
guidance products repackaged by State- AGENCY: Food and Drug Administration, date.
licensed pharmacies, Federal facilities, HHS. Electronic Submissions
and outsourcing facilities as defined ACTION: Notice of public meeting;
under section 503B of the Federal Food, request for comments. Submit electronic comments in the
Drug, and Cosmetic Act (21 U.S.C. following way:
353b). SUMMARY: The Food and Drug • Federal eRulemaking Portal:
• Excludes from the scope of the Administration (FDA or the Agency) is https://www.regulations.gov. Follow the
sradovich on DSK3GMQ082PROD with NOTICES
guidance all dosage forms other than announcing a public meeting to convene instructions for submitting comments.
solid oral dosage forms. a discussion of topics related to the Comments submitted electronically,
• Provides for the use of containers structured assessment of benefits and including attachments, to https://
meeting USP <671> Class B standards if risks in drug regulatory decision- www.regulations.gov will be posted to
certain conditions are met. making. This meeting will focus on the docket unchanged. Because your
This revised draft guidance is being regulatory and industry experiences comment will be made public, you are
issued consistent with FDA’s good with approaches to structured benefit- solely responsible for ensuring that your
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![37232 Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices
agencies, industry, and external DEPARTMENT OF HEALTH AND comment does not include any
perspectives and experiences with HUMAN SERVICES confidential information that you or a
structured benefit-risk assessment. This third party may not wish to be posted,
public meeting will have discussion Food and Drug Administration such as medical information, your or
sessions focusing on the entire drug [Docket No. FDA–2017–D–2802]
anyone else’s Social Security number, or
development life cycle, including confidential business information, such
premarket drug review and postmarket Chemistry, Manufacturing, and as a manufacturing process. Please note
safety surveillance. The format of the Controls Postapproval Manufacturing that if you include your name, contact
meeting consists of a series of Changes for Specified Biological information, or other information that
Products To Be Documented in Annual identifies you in the body of your
presentations on topics related to
Reports; Draft Guidance for Industry; comments, that information will be
structured assessment of benefits and
Availability posted on https://www.regulations.gov.
risks, followed by a discussion on those • If you want to submit a comment
topics with invited panelists and AGENCY: Food and Drug Administration, with confidential information that you
audience members. HHS. do not wish to be made available to the
III. Meeting Attendance and ACTION: Notice of availability. public, submit the comment as a
Participation written/paper submission and in the
SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper
Registration: If you wish to attend this Administration (FDA or Agency) is Submissions’’ and ‘‘Instructions’’).
meeting, visit https:// announcing the availability of a draft
Written/Paper Submissions
fdabenefitrisk.eventbrite.com. Please guidance for industry entitled ‘‘CMC
register by September 11, 2017. If you Postapproval Manufacturing Changes Submit written/paper submissions as
for Specified Biological Products To Be follows:
are unable to attend the meeting in • Mail/Hand delivery/Courier (for
person, you can register to view a live Documented in Annual Reports.’’ This
draft guidance provides written/paper submissions): Dockets
webcast of the meeting. You will be Management Staff (HFA–305), Food and
asked to indicate in your registration if recommendations to holders of biologics
license applications (BLAs) for specified Drug Administration, 5630 Fishers
you plan to attend in person or via the Lane, Rm. 1061, Rockville, MD 20852.
products regarding the types of changes
webcast. Seating will be limited, so
to be documented in annual reports. • For written/paper comments
early registration is recommended. Specifically, the draft guidance submitted to the Dockets Management
Registration is free and will be on a describes chemistry, manufacturing, and Staff, FDA will post your comment, as
first-come, first-served basis. However, controls (CMC) postapproval well as any attachments, except for
FDA may limit the number of manufacturing changes that the Agency information submitted, marked and
participants from each organization generally considers to have a minimal identified, as confidential, if submitted
based on space limitations. Registrants potential to have an adverse effect on as detailed in ‘‘Instructions.’’
the identity, strength, quality, purity, or Instructions: All submissions received
will receive confirmation once they
potency of the product as they may must include the Docket No. FDA–
have been accepted. Onsite registration 2017–D–2802 for ‘‘CMC Postapproval
on the day of the meeting will be based relate to the safety or effectiveness of the
product. Under FDA regulations, such Manufacturing Changes for Specified
on space availability. Biological Products To Be Documented
minor changes in the product,
If you need special accommodations in Annual Reports.’’ Received
production process, quality controls,
because of a disability, please contact equipment, facilities, or responsible comments will be placed in the docket
Graham Thompson (see FOR FURTHER personnel must be documented by and, except for those submitted as
INFORMATION CONTACT) at least 7 days applicants in an annual report. ‘‘Confidential Submissions,’’ publicly
before the meeting. viewable at https://www.regulations.gov
DATES: Although you can comment on
Transcripts: Please be advised that as or at the Dockets Management Staff
any guidance at any time (see 21 CFR between 9 a.m. and 4 p.m., Monday
soon as a transcript of the public 10.115(g)(5)), to ensure that the Agency through Friday.
meeting is available, it will be accessible considers your comment on this draft • Confidential Submissions—To
at https://www.regulations.gov. It may guidance before it begins work on the submit a comment with confidential
be viewed at the Dockets Management final version of the guidance, submit information that you do not wish to be
Staff (see ADDRESSES). A link to the either electronic or written comments made publicly available, submit your
transcript will also be available on the on the draft guidance by October 10, comments only as a written/paper
internet at https://www.fda.gov/ 2017. submission. You should submit two
forindustry/userfees/prescriptiondrug ADDRESSES: You may submit comments copies total. One copy will include the
userfee/ucm378861.htm. as follows: information you claim to be confidential
Dated: August 3, 2017. with a heading or cover note that states
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Anna K. Abram,
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
Deputy Commissioner for Policy, Planning, Agency will review this copy, including
following way:
Legislation, and Analysis.
• Federal eRulemaking Portal: the claimed confidential information, in
[FR Doc. 2017–16720 Filed 8–8–17; 8:45 am]
https://www.regulations.gov. Follow the its consideration of comments. The
sradovich on DSK3GMQ082PROD with NOTICES
BILLING CODE 4164–01–P instructions for submitting comments. second copy, which will have the
Comments submitted electronically, claimed confidential information
including attachments, to https:// redacted/blacked out, will be available
www.regulations.gov will be posted to for public viewing and posted on
the docket unchanged. Because your https://www.regulations.gov. Submit
comment will be made public, you are both copies to the Dockets Management
solely responsible for ensuring that your Staff. If you do not wish your name and
VerDate Sep<11>2014 17:00 Aug 08, 2017 Jkt 241001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\09AUN1.SGM 09AUN1](https://thefederalregister.org/doc/82_FR_37382/page/3.svg)
Document Created: 2017-08-09 02:18:17
Document Modified: 2017-08-09 02:18:17
| 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 public meeting; request for comments. | |
| Dates | The public meeting will be held on September 18, 2017, from 9 a.m. to 5 p.m. Registration to attend the meeting must be received by September 11, 2017 (see the SUPPLEMENTARY INFORMATION section for instructions). Public comments will be accepted through November 18, | |
| Contact | Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 301- 796-5003, FAX: 301-847-8443, [email protected] | |
| FR Citation | 82 FR 37230 |
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