82 FR 49838 - Patient-Focused Drug Development: Guidance 1-Collecting Comprehensive and Representative Input; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 207 (October 27, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 207 (October 27, 2017)
| Page Range | 49838-49840 | |
| FR Document | 2017-23437 |
[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)] [Notices] [Pages 49838-49840] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23437] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5896] Patient-Focused Drug Development: Guidance 1--Collecting Comprehensive and Representative Input; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing a public workshop to convene a discussion on methodological approaches that a person seeking to collect patient experience data for submission to FDA to inform regulatory decision making may use. The methods and approaches would be considered relevant and objective, and ensure that collected data are accurate and representative of the intended population, including methods to collect meaningful patient input throughout the drug development process and methodological considerations for data collection, reporting, management, and analysis. This workshop will inform development of patient-focused drug development [[Page 49839]] guidance as required by the 21st Century Cures Act (Cures Act), and as part of commitments made by FDA under the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA VI). FDA will publish a discussion document approximately 1 month before the workshop date. FDA is interested in seeking information and comments on the approaches proposed in the discussion document. FDA is also interested in input on examples where the approaches proposed in the discussion document have been successfully applied that could be illustrated in the draft guidance. DATES: The public workshop will be held on December 18, 2017, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by February 16, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Workshop updates, agenda, and discussion document will be made available at: https://www.fda.gov/Drugs/NewsEvents/ucm574725.htm prior to the workshop. 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 February 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of February 16, 2018. 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 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-5896 for ``Patient-Focused Drug Development: Guidance 1-- Collecting Comprehensive and Representative Input; Public Workshop; 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. FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240- 402-6525, Fax: 301-847-8443, [email protected]. SUPPLEMENTARY INFORMATION: I. Background This public workshop is intended to support FDA implementation of requirements for guidance development under section 3002 of the Cures Act and to meet a performance goal included in the sixth reauthorization of PDUFA VI. This reauthorization, part of the FDA Reauthorization Act of 2017 (FDARA) signed by the President on August 18, 2017, includes a number of performance goals and procedures that are documented in the PDUFA VI Commitment Letter, which is available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf. Section 3002 of Title III, Subtitle A of the Cures Act directs FDA to develop patient-focused drug development guidance to address a number of areas including under section 3002(c)(1): Methodological approaches, which are relevant and objective and ensure that such data are accurate and representative of the intended population, that a person seeking to [[Page 49840]] collect patient experience data to inform regulatory decision making may use. In addition, FDA committed to meet certain performance goals under PDUFA VI. These goal commitments were developed in consultation with patient and consumer advocates, health care professionals, and other public stakeholders, as part of negotiations with regulated industry. Section J.1 of the commitment letter, ``Enhancing the Incorporation of the Patient's Voice in Drug Development and Decision-Making,'' (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf) outlines work, including the development of a series of guidance documents and associated public workshops to facilitate the advancement and use of systematic approaches to collect and utilize robust and meaningful patient and caregiver input that can more consistently inform drug development, and, as appropriate, regulatory decision making. Prior to the issuance of each guidance, as part of the development, FDA will conduct a public workshop to gather input from the wider community of patients, patient advocates, academic researchers, expert practitioners, drug developers, and other stakeholders. II. Purpose and Scope of Meeting FDA is announcing a public workshop to convene a discussion on topics related to approaches to collecting comprehensive and representative patient and caregiver input on burden of disease and current therapy. The purpose of this public workshop is to obtain feedback from stakeholders on considerations for: (1) Standardized nomenclature and terminologies for patient-focused drug development, (2) methods to collect meaningful patient input throughout the drug development process, and (3) methodological considerations for data collection, reporting, management, and analysis of patient input. FDA is seeking information and comments from a broad range of stakeholders, including patients, patient advocates, academic and medical researchers, expert practitioners, drug developers, and other interested persons. FDA will publish a discussion document outlining the topic areas that will be addressed in the draft guidance. This document will be published approximately 1 month before the workshop date on the Web site at: https://www.fda.gov/Drugs/NewsEvents/ucm574725.htm. FDA is interested in seeking information and comments on the approaches and considerations proposed in the discussion document, as well as the examples provided. FDA is also interested in seeking information and comments on additional examples where the approaches proposed in the discussion document have been successfully applied that could be included in guidance. After this public workshop, FDA will take into consideration the stakeholder input from the workshop and the public docket, and publish a draft guidance by the end of the third quarter of fiscal year 2018. Registration: Interested parties are encouraged to register early. To register electronically, please visit: https://pfdd.eventbrite.com. Persons without access to the internet can call 240-402-6525 to register. 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 Meghana Chalasani (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting. Request for Oral Presentations: There will be time allotted during the workshop for open public comment. Sign-up for this session will be on a first-come, first-serve basis on the day of the workshop. Individuals and organizations with common interests are urged to consolidate or coordinate, and request time for a joint presentation. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Transcripts: As soon as a transcript is available, FDA will post it at https://www.fda.gov/Drugs/NewsEvents/ucm574725.htm. Dated: October 23, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-23437 Filed 10-26-17; 8:45 am] BILLING CODE 4164-01-P
![49838 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
• If you want to submit a comment FR 56469, September 18, 2015, or access II. The Paperwork Reduction Act of
with confidential information that you the information at: https://www.gpo.gov/ 1995
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- This guidance refers to previously
public, submit the comment as a 23389.pdf. approved collections of information that
written/paper submission and in the Docket: For access to the docket to are subject to review by the Office of
manner detailed (see ‘‘Written/Paper read background documents or the Management and Budget (OMB) under
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments the Paperwork Reduction Act of 1995
Written/Paper Submissions received, go to https://www. (44 U.S.C. 3501–3520). The collections
regulations.gov and insert the docket of information in 21 CFR parts 312 and
Submit written/paper submissions as
number, found in brackets in the 314 have been approved under OMB
follows:
• Mail/Hand delivery/Courier (for heading of this document, into the control numbers 0910–0014 and 0910–
written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts 0001, respectively. The collections of
Management Staff (HFA–305), Food and and/or go to the Dockets Management information in 21 CFR 201.56 and
Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, 201.57 have been approved under OMB
Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. control number 0910–0572.
• For written/paper comments You may submit comments on any III. Electronic Access
submitted to the Dockets Management guidance at any time (see 21 CFR
Staff, FDA will post your comment, as 10.115(g)(5)). Persons with access to the internet
well as any attachments, except for may obtain the draft guidance at either
Submit written requests for single https://www.fda.gov/Drugs/Guidance
information submitted, marked and copies of the draft guidance to the
identified, as confidential, if submitted ComplianceRegulatoryInformation/
Division of Drug Information, Center for Guidances/default.htm or https://www.
as detailed in ‘‘Instructions.’’ Drug Evaluation and Research, Food
Instructions: All submissions received regulations.gov.
and Drug Administration, 10001 New
must include the Docket No. FDA– Hampshire Ave., Hillandale Building, Dated: October 23, 2017.
2017–D–5912 for ‘‘Pediatric 4th Floor, Silver Spring, MD 20993– Anna K. Abram,
Gastroesophageal Reflux Disease:
0002. Send one self-addressed adhesive Deputy Commissioner for Policy, Planning,
Developing Drugs for Treatment; Draft Legislation, and Analysis.
label to assist that office in processing
Guidance for Industry; Availability.’’
your requests. See the SUPPLEMENTARY [FR Doc. 2017–23436 Filed 10–26–17; 8:45 am]
Received comments will be placed in
INFORMATION section for electronic BILLING CODE 4164–01–P
the docket and, except for those
access to the draft guidance document.
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
https://www.regulations.gov or at the Stacy Barley, Center for Drug Evaluation HUMAN SERVICES
Dockets Management Staff between 9 and Research, Food and Drug
a.m. and 4 p.m., Monday through Administration, 10903 New Hampshire Food and Drug Administration
Friday. Ave., Bldg. 75, Rm. 2642, Silver Spring,
• Confidential Submissions: To MD 20993–0002, 301–796–2137. [Docket No. FDA–2017–N–5896]
submit a comment with confidential
SUPPLEMENTARY INFORMATION: Patient-Focused Drug Development:
information that you do not wish to be
Guidance 1—Collecting
made publicly available, submit your I. Background
Comprehensive and Representative
comments only as a written/paper
FDA is announcing the availability of Input; Public Workshop; Request for
submission. You should submit two
a draft guidance for industry entitled Comments
copies total. One copy will include the
information you claim to be confidential ‘‘Pediatric Gastroesophageal Reflux AGENCY: Food and Drug Administration,
with a heading or cover note that states Disease: Developing Drugs for HHS.
‘‘THIS DOCUMENT CONTAINS Treatment.’’ The purpose of this draft
guidance is to assist sponsors in the ACTION: Notice of public workshop;
CONFIDENTIAL INFORMATION.’’ The request for comments.
Agency will review this copy, including clinical development of drugs for the
the claimed confidential information, in treatment of GERD in the pediatric SUMMARY: The Food and Drug
its consideration of comments. The patient population, including guidance Administration (FDA) is announcing a
second copy, which will have the on clinical presentation by age and public workshop to convene a
claimed confidential information disease, study populations, endpoints, discussion on methodological
redacted/blacked out, will be available and pharmacometric issues affecting approaches that a person seeking to
for public viewing and posted on http:// dosing. collect patient experience data for
www.regulations.gov. Submit both This draft guidance is being issued submission to FDA to inform regulatory
copies to the Dockets Management Staff. consistent with FDA’s good guidance decision making may use. The methods
If you do not wish your name and practices regulation (21 CFR 10.115). and approaches would be considered
contact information to be made publicly The draft guidance, when finalized, will relevant and objective, and ensure that
available, you can provide this represent the current thinking of FDA collected data are accurate and
asabaliauskas on DSKBBXCHB2PROD with NOTICES
information on the cover sheet and not on the development of drugs for the representative of the intended
in the body of your comments and you treatment of GERD in the pediatric population, including methods to
must identify this information as patient population. It does not establish collect meaningful patient input
‘‘confidential.’’ Any information marked any rights for any person and is not throughout the drug development
as ‘‘confidential’’ will not be disclosed binding on FDA or the public. You can process and methodological
except in accordance with 21 CFR 10.20 use an alternative approach if it satisfies considerations for data collection,
and other applicable disclosure law. For the requirements of the applicable reporting, management, and analysis.
more information about FDA’s posting statutes and regulations. This guidance This workshop will inform development
of comments to public dockets, see 80 is not subject to Executive Order 12866. of patient-focused drug development
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![49840 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
collect patient experience data to inform as well as the examples provided. FDA DEPARTMENT OF HEALTH AND
regulatory decision making may use. is also interested in seeking information HUMAN SERVICES
In addition, FDA committed to meet and comments on additional examples
certain performance goals under PDUFA where the approaches proposed in the Food and Drug Administration
VI. These goal commitments were discussion document have been [Docket No. FDA–2017–P–2660]
developed in consultation with patient successfully applied that could be
and consumer advocates, health care included in guidance. After this public Determination That CARDENE SR
professionals, and other public workshop, FDA will take into (Nicardipine HCl) Extended-Release
stakeholders, as part of negotiations Capsules, 30 Milligrams, 45 Milligrams,
consideration the stakeholder input
with regulated industry. Section J.1 of and 60 Milligrams, Were Not
from the workshop and the public
the commitment letter, ‘‘Enhancing the Withdrawn From Sale for Reasons of
Incorporation of the Patient’s Voice in docket, and publish a draft guidance by
the end of the third quarter of fiscal year Safety or Effectiveness
Drug Development and Decision-
Making,’’ (https://www.fda.gov/ 2018. AGENCY: Food and Drug Administration,
downloads/ForIndustry/UserFees/ Registration: Interested parties are HHS.
PrescriptionDrugUserFee/ encouraged to register early. To register ACTION: Notice.
UCM511438.pdf) outlines work, electronically, please visit: https://
including the development of a series of pfdd.eventbrite.com. Persons without SUMMARY: The Food and Drug
guidance documents and associated access to the internet can call 240–402– Administration (FDA or Agency) has
public workshops to facilitate the 6525 to register. If you are unable to determined that CARDENE SR
advancement and use of systematic attend the meeting in person, you can (nicardipine HCl) extended-release
approaches to collect and utilize robust register to view a live webcast of the capsules, 30 milligrams (mg), 45 mg,
and meaningful patient and caregiver meeting. You will be asked to indicate and 60 mg, were not withdrawn from
input that can more consistently inform sale for reasons of safety or
in your registration if you plan to attend
drug development, and, as appropriate, effectiveness. This determination will
in person or via the webcast. Seating
regulatory decision making. allow FDA to approve abbreviated new
Prior to the issuance of each guidance, will be limited, so early registration is
drug applications (ANDAs) for
as part of the development, FDA will recommended. Registration is free and
nicardipine HCl extended-release
conduct a public workshop to gather will be on a first-come, first-served
capsules, 30 mg, 45 mg, and 60 mg, if
input from the wider community of basis. However, FDA may limit the all other legal and regulatory
patients, patient advocates, academic number of participants from each requirements are met.
researchers, expert practitioners, drug organization based on space limitations.
FOR FURTHER INFORMATION CONTACT:
developers, and other stakeholders. Registrants will receive confirmation
Daniel Gottlieb, Center for Drug
once they have been accepted. Onsite
II. Purpose and Scope of Meeting Evaluation and Research, Food and
registration on the day of the meeting Drug Administration, 10903 New
FDA is announcing a public will be based on space availability.
workshop to convene a discussion on Hampshire Ave., Bldg. 51, Rm. 6208,
topics related to approaches to If you need special accommodations Silver Spring, MD 20993–0002, 301–
collecting comprehensive and because of a disability, please contact 796–6650.
representative patient and caregiver Meghana Chalasani (see FOR FURTHER SUPPLEMENTARY INFORMATION: In 1984,
input on burden of disease and current INFORMATION CONTACT) at least 7 days Congress enacted the Drug Price
therapy. The purpose of this public before the meeting. Competition and Patent Term
workshop is to obtain feedback from Request for Oral Presentations: There Restoration Act of 1984 (Pub. L. 98–417)
stakeholders on considerations for: (1) will be time allotted during the (the 1984 amendments), which
Standardized nomenclature and workshop for open public comment. authorized the approval of duplicate
terminologies for patient-focused drug Sign-up for this session will be on a versions of drug products under an
development, (2) methods to collect first-come, first-serve basis on the day of ANDA procedure. ANDA applicants
meaningful patient input throughout the the workshop. Individuals and must, with certain exceptions, show that
drug development process, and (3) organizations with common interests are the drug for which they are seeking
methodological considerations for data approval contains the same active
urged to consolidate or coordinate, and
collection, reporting, management, and ingredient in the same strength and
request time for a joint presentation. No
analysis of patient input. FDA is seeking dosage form as the listed drug, which is
information and comments from a broad commercial or promotional material a version of the drug that was
range of stakeholders, including will be permitted to be presented or previously approved. ANDA applicants
patients, patient advocates, academic distributed at the public workshop. do not have to repeat the extensive
and medical researchers, expert Transcripts: As soon as a transcript is clinical testing otherwise necessary to
practitioners, drug developers, and available, FDA will post it at https:// gain approval of a new drug application
other interested persons. FDA will www.fda.gov/Drugs/NewsEvents/ (NDA).
publish a discussion document ucm574725.htm. The 1984 amendments include what
outlining the topic areas that will be is now section 505(j)(7) of the Federal
Dated: October 23, 2017.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
addressed in the draft guidance. This Food, Drug, and Cosmetic Act (21 U.S.C.
document will be published Anna K. Abram, 355(j)(7)), which requires FDA to
approximately 1 month before the Deputy Commissioner for Policy, Planning, publish a list of all approved drugs.
workshop date on the Web site at: Legislation, and Analysis. FDA publishes this list as part of the
https://www.fda.gov/Drugs/NewsEvents/ [FR Doc. 2017–23437 Filed 10–26–17; 8:45 am] ‘‘Approved Drug Products with
ucm574725.htm. FDA is interested in BILLING CODE 4164–01–P Therapeutic Equivalence Evaluations,’’
seeking information and comments on which is known generally as the Orange
the approaches and considerations Book. Under FDA regulations, drugs are
proposed in the discussion document, removed from the list if the Agency
VerDate Sep<11>2014 17:54 Oct 26, 2017 Jkt 244001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\27OCN1.SGM 27OCN1](https://thefederalregister.org/doc/82_FR_50045/page/3.svg)
Document Created: 2017-10-27 02:06:30
Document Modified: 2017-10-27 02:06:30
| 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 workshop; request for comments. | |
| Dates | The public workshop will be held on December 18, 2017, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by February 16, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Meghana Chalasani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240- 402-6525, Fax: 301-847-8443, [email protected] | |
| FR Citation | 82 FR 49838 |
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