80 FR 73774 - Public Meeting on Patient-Focused Drug Development for Psoriasis
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 227 (November 25, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 227 (November 25, 2015)
| Page Range | 73774-73776 | |
| FR Document | 2015-29992 |
[Federal Register Volume 80, Number 227 (Wednesday, November 25, 2015)] [Notices] [Pages 73774-73776] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29992] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-4166] Public Meeting on Patient-Focused Drug Development for Psoriasis AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for Psoriasis. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of psoriasis, including on daily life and patient views on treatment approaches. FDA is interested in patients' perspectives for the types of psoriasis with primarily skin symptoms (such plaque psoriasis, nail psoriasis, guttate psoriasis, etc.), patient views on treatment approaches, and decision factors taken into account when selecting a treatment. DATES: The public meeting will be held on March 17, 2016, from 10 a.m. to 6 p.m. Registration to attend the meeting must be received by March 10, 2016 (see SUPPLEMENTARY INFORMATION for instructions). Submit electronic or written comments to the public docket by May 17, 2016. ADDRESSES: You may submit comments as follows: [[Page 73775]] 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-2013-N-0418 for ``An Evaluation of the Prescription Drug User Fee Act Workload Adjuster; Request for Comments.'' 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. FDA will post the agenda approximately 5 days before the meeting at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm. 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 on Patient-Focused Drug Development FDA has selected psoriasis as the focus of a public meeting under Patient-Focused Drug Development, an initiative that involves obtaining a better understanding of patient perspectives on the severity of a disease and the available therapies for that condition. Patient-Focused Drug Development is being conducted to fulfill FDA performance commitments that are part of the reauthorization of the PDUFA under Title I of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144). The full set of performance commitments is available at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf. FDA committed to obtain the patient perspective on at least 20 disease areas during the course of PDUFA V. For each disease area, the Agency is conducting a public meeting to discuss the disease and its impact on patients' daily lives, the types of treatment benefit that matter most to patients, and patients' perspectives on the adequacy of the available therapies. These meetings will include participation of FDA review divisions, the relevant patient communities, and other interested stakeholders. On April 11, 2013, FDA published a notice in the Federal Register (78 FR 08441) announcing the disease areas for meetings in fiscal years (FYs) 2013-2015, the first 3 years of the 5-year PDUFA V time frame. The Agency used several criteria outlined in that notice to develop the list of disease areas. FDA obtained public comment on the Agency's proposed criteria and potential disease areas through a public docket and a public meeting that was convened on October 25, 2012. In selecting the set of disease areas, FDA carefully considered the public comments received and the perspectives of review divisions at FDA. FDA initiated a second public process for determining the disease areas for FY 2016-2017, and published a notice in the Federal Register on July 2, 2015, announcing the selection of eight disease areas. More information, including the list of disease areas and a general schedule of meetings, is posted at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm. II. Public Meeting Information A. Purpose and Scope of the Meeting As part of Patient-Focused Drug Development, FDA will obtain patient and patient stakeholder input on the symptoms of psoriasis that matter most to patients and on current approaches to treating psoriasis. Psoriasis is a chronic, immune-mediated skin condition that is associated with both a physical and psychological burden. It is characterized by areas of red, thickened, scaling skin and may be accompanied by itching or soreness. While there is currently no cure, treatments for psoriasis include topical therapies such as corticosteroids [[Page 73776]] and vitamin D analogs, systemic drugs, biologic products, and phototherapy. FDA is interested in the perspectives of patients with psoriasis on (1) the impact of their skin disease, including the extent and location (e.g., nail, palm, scalp, genital) of involvement, (2) treatment approaches, and (3) decision factors taken into account when selecting a treatment. The questions that will be asked of patients and patient stakeholders at the meeting are listed in this section, organized by topic. For each topic, a brief initial patient panel discussion will begin the dialogue. This will be followed by a facilitated discussion inviting comments from other patient and patient stakeholder participants. In addition to input generated through this public meeting, FDA is interested in receiving patient input addressing these questions through written comments, which can be submitted to the public docket (see ADDRESSES). Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients (1) Of all the symptoms that you experience because of your condition, which one to three symptoms have the most significant impact on your life? (Examples may include red, thickened, scaling skin, itching, burning, or soreness, etc.) (2) Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? (Examples of activities may include sleeping through the night, daily hygiene, participation in sports or social activities, intimacy with a spouse or partner, etc.) (3) How do your symptoms and their negative impacts affect your daily life on the best days? On the worst days? (4) How have your condition and its symptoms changed over time? (a) Would you define your condition today as being well managed? (5) What worries you most about your condition? Topic 2: Patients' Perspectives on Current Approaches to Treatment (1) What are you currently doing to help treat your condition or its symptoms? (Examples may include prescription medicines, over-the- counter products, phototherapy, and other therapies including non-drug therapies such as diet modification.) (a) How has your treatment regimen changed over time, and why? (2) How well does your current treatment regimen control your condition? (a) How well do your treatments address specific skin symptoms? Which symptoms are not addressed as well? (b) How well have these treatments worked for you as your condition has changed over time? (3) What are the most significant downsides to your current treatments, and how do they affect your daily life? (Examples of downsides may include going to the hospital or clinic for treatment, time devoted to treatment, etc.) (4) Assuming there is no complete cure for your condition, what specific things would you look for in an ideal treatment for your condition? (a) What would you consider to be a meaningful improvement (for example symptom improvements or functional improvements) in your condition that a treatment could provide? (5) What factors do you take into account when making decisions about selecting a course of treatment? (a) What information on the potential benefits of these treatments factors most into your decision? (b) How do you weigh the potential benefits of these treatments versus the common side effects of the treatments? (Common side effects could include headache, nausea, injection site reactions.) (c) How do you weigh potential benefits of these treatments versus the less common but serious risks associated with the treatments? (Examples of less common but serious risks are infections, cancer, liver damage, kidney damage, birth defects, blood disorders, etc.) B. Meeting Attendance and Participation If you wish to attend this meeting, visit https://psoriasispfdd.eventbrite.com. Please register by March 10, 2016. 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. Patients who are interested in presenting comments as part of the initial panel discussions will be asked to indicate in their registration which topic(s) they wish to address. These patients also must send to [email protected] a brief summary of responses to the topic questions by February 29, 2016. Panelists will be notified of their selection approximately 7 days before the public meeting. We will try to accommodate all patients and patient stakeholders who wish to speak, either through the panel discussion or audience participation; however, the duration of comments may be limited by time constraints. Docket Comments: Regardless of whether you attend the public meeting, you can submit electronic or written responses to the questions pertaining to Topics 1 and 2 to the public docket (see ADDRESSES) by May 17, 2016. Transcripts: As soon as a transcript is available, FDA will post it at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm. Dated: November 19, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-29992 Filed 11-24-15; 8:45 am] BILLING CODE 4164-01-P
![73774 Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Notices
on approximately 10,250 gas containers is already consistent with the information to ensure that their labeling
(‘‘frequency of disclosure’’ in table 3), recommendations in the revised draft is consistent with the revised draft
resulting in approximately 41,000,000 guidance. As a result, FDA estimates guidance.
labels (‘‘total disclosures’’ in table 3). that it will take each person or entity FDA estimates the information
FDA expects that the labeling approximately 0.1 hours (‘‘hours per collection resulting from the revised
information currently used by industry disclosure’’ in table 3) to review the draft guidance as follows:
TABLE 1—ESTIMATED REPORTING BURDEN1
Average
Number of
Number of Total burden per
Form FDA 3864 and other requested information responses per Total hours
respondents responses response
respondent (in hours)
Certification Requests During the First Year ....................... 31 2.03 63 2 126
Certification Requests Annually After the First Year ........... 5 1 5 2 10
Total .............................................................................. ........................ ........................ ........................ ........................ 136
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED RECORDKEEPING BURDEN1
Average bur-
Number of
Number of den per rec-
records per Total records Total hours
recordkeepers ordkeeping
recordkeeper (in hours)
Verification and documentation of certified sources by per-
sons or entities who market a medical gas but are nei-
ther the original manufacturer nor the original marketer 4,000 3 12,000 0.25 3,000
(15 minutes)
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN1
Number of Frequency of Total Hours per Total hours
respondents disclosure disclosures disclosure
Providing documentation of certification .............................. 3,500 5 17,500 0.25 4,375
(15 minutes)
Labeling required under section 576(a)(3)(A)(ii) of the
FD&C Act ......................................................................... 4,000 10,250 41,000,000 0.1 4,100,000
(6 minutes)
Total .............................................................................. ........................ ........................ ........................ ........................ 4,104,375
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access DEPARTMENT OF HEALTH AND V). The public meeting is intended to
HUMAN SERVICES allow FDA to obtain patient
Persons with access to the Internet perspectives on the impact of psoriasis,
may obtain the draft guidance at either Food and Drug Administration including on daily life and patient
http://www.fda.gov/ views on treatment approaches. FDA is
RegulatoryInformation/Guidances/ [Docket No. FDA–2015–N–4166] interested in patients’ perspectives for
default.htm or http:// the types of psoriasis with primarily
Public Meeting on Patient-Focused
www.regulations.gov. skin symptoms (such plaque psoriasis,
Drug Development for Psoriasis
Dated: November 19, 2015. nail psoriasis, guttate psoriasis, etc.),
AGENCY: Food and Drug Administration, patient views on treatment approaches,
Leslie Kux,
HHS. and decision factors taken into account
Associate Commissioner for Policy. when selecting a treatment.
ACTION: Notice of public meeting;
[FR Doc. 2015–29989 Filed 11–24–15; 8:45 am]
request for comments. DATES: The public meeting will be held
BILLING CODE 4164–01–P
on March 17, 2016, from 10 a.m. to 6
SUMMARY: The Food and Drug
p.m. Registration to attend the meeting
Administration (FDA) is announcing a
must be received by March 10, 2016 (see
tkelley on DSK3SPTVN1PROD with NOTICES
public meeting and an opportunity for
SUPPLEMENTARY INFORMATION for
public comment on Patient-Focused
instructions). Submit electronic or
Drug Development for Psoriasis. Patient-
written comments to the public docket
Focused Drug Development is part of
by May 17, 2016.
FDA’s performance commitments made
as part of the fifth authorization of the ADDRESSES: You may submit comments
Prescription Drug User Fee Act (PDUFA as follows:
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![73776 Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Notices
and vitamin D analogs, systemic drugs, (a) How well do your treatments Patients who are interested in
biologic products, and phototherapy. address specific skin symptoms? Which presenting comments as part of the
FDA is interested in the perspectives of symptoms are not addressed as well? initial panel discussions will be asked
patients with psoriasis on (1) the impact (b) How well have these treatments to indicate in their registration which
of their skin disease, including the worked for you as your condition has topic(s) they wish to address. These
extent and location (e.g., nail, palm, changed over time? patients also must send to
scalp, genital) of involvement, (2) (3) What are the most significant PatientFocused@fda.hhs.gov a brief
treatment approaches, and (3) decision downsides to your current treatments, summary of responses to the topic
factors taken into account when and how do they affect your daily life? questions by February 29, 2016.
selecting a treatment. (Examples of downsides may include Panelists will be notified of their
The questions that will be asked of going to the hospital or clinic for selection approximately 7 days before
patients and patient stakeholders at the treatment, time devoted to treatment, the public meeting. We will try to
meeting are listed in this section, etc.) accommodate all patients and patient
organized by topic. For each topic, a (4) Assuming there is no complete stakeholders who wish to speak, either
brief initial patient panel discussion cure for your condition, what specific through the panel discussion or
will begin the dialogue. This will be things would you look for in an ideal audience participation; however, the
followed by a facilitated discussion treatment for your condition? duration of comments may be limited by
(a) What would you consider to be a time constraints.
inviting comments from other patient
meaningful improvement (for example Docket Comments: Regardless of
and patient stakeholder participants. In
symptom improvements or functional whether you attend the public meeting,
addition to input generated through this
improvements) in your condition that a you can submit electronic or written
public meeting, FDA is interested in
treatment could provide? responses to the questions pertaining to
receiving patient input addressing these
(5) What factors do you take into
questions through written comments, Topics 1 and 2 to the public docket (see
account when making decisions about
which can be submitted to the public ADDRESSES) by May 17, 2016.
selecting a course of treatment?
docket (see ADDRESSES). (a) What information on the potential Transcripts: As soon as a transcript is
benefits of these treatments factors most available, FDA will post it at http://
Topic 1: Disease Symptoms and Daily
into your decision? www.fda.gov/ForIndustry/UserFees/
Impacts That Matter Most to Patients
(b) How do you weigh the potential PrescriptionDrugUserFee/
(1) Of all the symptoms that you benefits of these treatments versus the ucm470608.htm.
experience because of your condition, common side effects of the treatments? Dated: November 19, 2015.
which one to three symptoms have the (Common side effects could include Leslie Kux,
most significant impact on your life? headache, nausea, injection site Associate Commissioner for Policy.
(Examples may include red, thickened, reactions.) [FR Doc. 2015–29992 Filed 11–24–15; 8:45 am]
scaling skin, itching, burning, or (c) How do you weigh potential
BILLING CODE 4164–01–P
soreness, etc.) benefits of these treatments versus the
(2) Are there specific activities that less common but serious risks
are important to you but that you cannot associated with the treatments? DEPARTMENT OF HEALTH AND
do at all or as fully as you would like (Examples of less common but serious HUMAN SERVICES
because of your condition? (Examples of risks are infections, cancer, liver
activities may include sleeping through damage, kidney damage, birth defects, Health Resources and Services
the night, daily hygiene, participation in blood disorders, etc.) Administration
sports or social activities, intimacy with
B. Meeting Attendance and Agency Information Collection
a spouse or partner, etc.)
Participation Activities: Proposed Collection: Public
(3) How do your symptoms and their
negative impacts affect your daily life If you wish to attend this meeting, Comment Request
on the best days? On the worst days? visit https://
psoriasispfdd.eventbrite.com. Please AGENCY: Health Resources and Services
(4) How have your condition and its Administration, HHS.
symptoms changed over time? register by March 10, 2016. If you are
unable to attend the meeting in person, ACTION: Notice.
(a) Would you define your condition
you can register to view a live Webcast
today as being well managed? SUMMARY: In compliance with the
of the meeting. You will be asked to
(5) What worries you most about your indicate in your registration if you plan requirement for opportunity for public
condition? to attend in person or via the Webcast. comment on proposed data collection
Topic 2: Patients’ Perspectives on Seating will be limited, so early projects (Section 3506(c)(2)(A) of the
Current Approaches to Treatment registration is recommended. Paperwork Reduction Act of 1995), the
Registration is free and will be on a first- Health Resources and Services
(1) What are you currently doing to come, first-served basis. However, FDA Administration (HRSA) announces
help treat your condition or its may limit the number of participants plans to submit an Information
symptoms? (Examples may include from each organization based on space Collection Request (ICR), described
prescription medicines, over-the- limitations. Registrants will receive below, to the Office of Management and
counter products, phototherapy, and confirmation once they have been Budget (OMB). Prior to submitting the
other therapies including non-drug ICR to OMB, HRSA seeks comments
tkelley on DSK3SPTVN1PROD with NOTICES
accepted. Onsite registration on the day
therapies such as diet modification.) of the meeting will be based on space from the public regarding the burden
(a) How has your treatment regimen availability. If you need special estimate, below, or any other aspect of
changed over time, and why? accommodations because of a disability, the ICR.
(2) How well does your current please contact Meghana Chalasani (see DATES: Comments on this Information
treatment regimen control your FOR FURTHER INFORMATION CONTACT) at Collection Request must be received no
condition? least 7 days before the meeting. later than January 25, 2016.
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Document Created: 2018-03-01 11:14:37
Document Modified: 2018-03-01 11:14:37
| 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 March 17, 2016, from 10 a.m. to 6 p.m. Registration to attend the meeting must be received by March 10, 2016 (see SUPPLEMENTARY INFORMATION for instructions). Submit electronic or written comments to the public docket by May 17, 2016. | |
| 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 | 80 FR 73774 |
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