Request for Nominations for Voting Members for the Patient Engagement Advisory Committee, 5450-5451 [2020-01659]

Download as PDF 5450 Federal Register / Vol. 85, No. 20 / Thursday, January 30, 2020 / Notices documents, entitled ‘‘Long Term Follow-Up After Administration of Human Gene Therapy Products; Guidance for Industry’’ and ‘‘Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Guidance for Industry,’’ announced elsewhere in this issue of the Federal Register. In the Federal Register of July 12, 2018 (83 FR 32309), FDA announced the availability of the draft guidance of the same title dated July 2018. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated July 2018. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents FDA’s current thinking on testing of retroviral vectorbased human gene therapy products for replication competent retrovirus during product manufacture and patient follow-up. 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 The 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– 3521). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014; and the collections of information in 21 CFR part 601 have been approved under OMB control number 0910–0338. khammond on DSKJM1Z7X2PROD with NOTICES III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ biologics-guidances or https:// www.regulations.gov. Dated: January 27, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–01700 Filed 1–29–20; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 16:56 Jan 29, 2020 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–0008] Request for Nominations for Voting Members for the Patient Engagement Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting nominations for voting members, excluding consumer representative, to serve on the Patient Engagement Advisory Committee (the Committee) in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. DATES: Nominations received on or before March 30, 2020, will be given first consideration for membership on the Committee. Nominations received after March 30, 2020, will be considered for nomination to the Committee as later vacancies occur. ADDRESSES: All nominations for membership should be submitted electronically by logging into the FDA Advisory Committee Membership Nomination Portal: https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm. Select Academician/Practitioner in the drop menu to apply for membership, or apply by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s website at https://www.fda.gov/Advisory Committees/default.htm. FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5407, 301–796– 8398, email: Letise.Williams@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting members to fill current and upcoming vacancies on the Patient Engagement SUMMARY: PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 Advisory Committee. This Notice does not include consumer and industry representative nominations. The Agency will publish two separate notices announcing the vacancy of a representative of consumer interests and vacancy of representatives of interests of the device manufacturing industry. I. General Description of the Committee Duties The Committee provides relevant skills and perspectives in order to improve communication of benefits, risks, and clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices. It performs its duties by identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy. The Committee provides advice on complex scientific issues relating to medical devices, the regulation of devices, and their use by patients. Agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient reported outcomes, and device-related quality of life measure or health status issues are among the topics that may be considered by the Committee. Members are knowledgeable in areas such as clinical research, primary care patient experience, healthcare needs of patient groups in the United States, or are experienced in the work of patient and health professional organizations, methodologies for eliciting patient preferences, and strategies for communicating benefits, risks, and clinical outcomes to patients and research subjects. II. Criteria for Voting Members The Committee consists of a core of nine voting members, including the Chair. Members and the Chair are selected by the Commissioner of Food and Drugs or designee from among authorities who are knowledgeable in areas such as clinical research, patient experience, healthcare needs of patient groups in the United States, or are experienced in the work of patient and health professional organizations, scientific methodologies for patientreported outcomes and eliciting patient preferences, and strategies for communicating benefits, risks, and clinical outcomes to patients and research subjects. Members will be invited to serve for overlapping terms of up to 4 years. Prospective members should also have E:\FR\FM\30JAN1.SGM 30JAN1 Federal Register / Vol. 85, No. 20 / Thursday, January 30, 2020 / Notices an understanding of the broad spectrum of patients in a particular disease area. Almost all non-Federal members of this Committee serve as Special Government Employees, with the exception of the representatives from Industry. III. Nomination Procedures Any interested person may nominate one or more qualified individuals for membership on the Committee. Selfnominations are also accepted. Nominations must include a cover letter; a current, complete resume or curriculum vitae for each nominee, including current business and/or home address, telephone number, and email address, if available; and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES). Nominations must specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters related to financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: January 24, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–01659 Filed 1–29–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–2258] Human Gene Therapy for Rare Diseases; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 16:56 Jan 29, 2020 Jkt 250001 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 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘Human Gene Therapy for Rare Diseases; Guidance for Industry.’’ The final guidance document provides recommendations to stakeholders developing a human gene therapy (GT) product intended to treat a rare disease in adult and/or pediatric patients regarding the manufacturing, SUMMARY: preclinical, and clinical trial design issues for all phases of the clinical development program. Such information is intended to assist sponsors in designing clinical development programs for such products, where there may be limited study population size and potential feasibility and safety issues as well as issues relating to the interpretability of bioactivity/efficacy outcomes that may be unique to rare diseases or to the nature of the GT product itself. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2018. DATES: The announcement of the guidance is published in the Federal Register on January 30, 2020. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: 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 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 5451 information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2018–D–2258 for ‘‘Human Gene Therapy for Rare Diseases; Guidance for Industry.’’ Received comments 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.govinfo.gov/content/pkg/FR-201509-18/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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development, Center for Biologics E:\FR\FM\30JAN1.SGM 30JAN1

Agencies

[Federal Register Volume 85, Number 20 (Thursday, January 30, 2020)]
[Notices]
[Pages 5450-5451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01659]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0008]


Request for Nominations for Voting Members for the Patient 
Engagement Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for voting members, excluding consumer representative, to 
serve on the Patient Engagement Advisory Committee (the Committee) in 
the Center for Devices and Radiological Health. Nominations will be 
accepted for current and upcoming vacancies effective with this notice. 
FDA seeks to include the views of women and men, members of all racial 
and ethnic groups, and individuals with and without disabilities on its 
advisory committees and, therefore, encourages nominations of 
appropriately qualified candidates from these groups.

DATES: Nominations received on or before March 30, 2020, will be given 
first consideration for membership on the Committee. Nominations 
received after March 30, 2020, will be considered for nomination to the 
Committee as later vacancies occur.

ADDRESSES: All nominations for membership should be submitted 
electronically by logging into the FDA Advisory Committee Membership 
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm. Select Academician/Practitioner in the drop menu to 
apply for membership, or apply by mail to Advisory Committee Oversight 
and Management Staff, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002. Information 
about becoming a member on an FDA advisory committee can also be 
obtained by visiting FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5407, 301-796-8398, email: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
members to fill current and upcoming vacancies on the Patient 
Engagement Advisory Committee. This Notice does not include consumer 
and industry representative nominations. The Agency will publish two 
separate notices announcing the vacancy of a representative of consumer 
interests and vacancy of representatives of interests of the device 
manufacturing industry.

I. General Description of the Committee Duties

    The Committee provides relevant skills and perspectives in order to 
improve communication of benefits, risks, and clinical outcomes, and 
increase integration of patient perspectives into the regulatory 
process for medical devices. It performs its duties by identifying new 
approaches, promoting innovation, recognizing unforeseen risks or 
barriers, and identifying unintended consequences that could result 
from FDA policy. The Committee provides advice on complex scientific 
issues relating to medical devices, the regulation of devices, and 
their use by patients. Agency guidance and policies, clinical trial or 
registry design, patient preference study design, benefit-risk 
determinations, device labeling, unmet clinical needs, available 
alternatives, patient reported outcomes, and device-related quality of 
life measure or health status issues are among the topics that may be 
considered by the Committee. Members are knowledgeable in areas such as 
clinical research, primary care patient experience, healthcare needs of 
patient groups in the United States, or are experienced in the work of 
patient and health professional organizations, methodologies for 
eliciting patient preferences, and strategies for communicating 
benefits, risks, and clinical outcomes to patients and research 
subjects.

II. Criteria for Voting Members

    The Committee consists of a core of nine voting members, including 
the Chair. Members and the Chair are selected by the Commissioner of 
Food and Drugs or designee from among authorities who are knowledgeable 
in areas such as clinical research, patient experience, healthcare 
needs of patient groups in the United States, or are experienced in the 
work of patient and health professional organizations, scientific 
methodologies for patient-reported outcomes and eliciting patient 
preferences, and strategies for communicating benefits, risks, and 
clinical outcomes to patients and research subjects.
    Members will be invited to serve for overlapping terms of up to 4 
years. Prospective members should also have

[[Page 5451]]

an understanding of the broad spectrum of patients in a particular 
disease area. Almost all non-Federal members of this Committee serve as 
Special Government Employees, with the exception of the representatives 
from Industry.

III. Nomination Procedures

    Any interested person may nominate one or more qualified 
individuals for membership on the Committee. Self-nominations are also 
accepted. Nominations must include a cover letter; a current, complete 
resume or curriculum vitae for each nominee, including current business 
and/or home address, telephone number, and email address, if available; 
and a signed copy of the Acknowledgement and Consent form available at 
the FDA Advisory Nomination Portal (see ADDRESSES). Nominations must 
specify the advisory committee for which the nominee is recommended.
    Nominations must also acknowledge that the nominee is aware of the 
nomination unless self-nominated. FDA will ask potential candidates to 
provide detailed information concerning such matters related to 
financial holdings, employment, and research grants and/or contracts to 
permit evaluation of possible sources of conflicts of interest.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: January 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01659 Filed 1-29-20; 8:45 am]
 BILLING CODE 4164-01-P

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