81_FR_52068 81 FR 51917 - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting

81 FR 51917 - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 151 (August 5, 2016)

Page Range51917-51918
FR Document2016-18560

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.

Federal Register, Volume 81 Issue 151 (Friday, August 5, 2016) 
[Federal Register Volume 81, Number 151 (Friday, August 5, 2016)]
[Notices]
[Pages 51917-51918]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18560]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Cellular, Tissue, and Gene Therapies Advisory Committee; Notice 
of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Cellular, Tissue, and Gene 
Therapies Advisory Committee. The general function of the committee is 
to provide advice and recommendations to the Agency on FDA's regulatory 
issues. At least one portion of the meeting will be closed to the 
public.

DATES: The meeting will be held on September 7, 2016, from 1 p.m. to 4 
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Janie Kim or Denise Royster, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 301-
796-9016 or 240-402-8158, [email protected] or 
[email protected]; or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in 
the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting. For those unable to attend in person, the meeting will 
also be available via Webcast. The Webcast will be available at the 
following link: https://collaboration.fda.gov/ctgtac0916/.

SUPPLEMENTARY INFORMATION: 
    Agenda: On September 7, 2016, the committee will meet by 
teleconference. In open session, the committee will hear updates of 
research programs in the Gene Transfer and Immunogenicity Branch, 
Division of Cellular and Gene Therapies, Office of Cellular, Tissue, 
and Gene Therapies, Center for Biologics Evaluation and Research.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: On September 7, 2016, from 1 p.m. to 2:20 p.m., the 
meeting is open to the public. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the committee. Written submissions may be made to the contact person on 
or before August 23, 2016. Oral presentations from the public will be 
scheduled between approximately 2:20 p.m. to 3:20 p.m. Those 
individuals interested in making formal oral presentations should 
notify the contact person and submit a brief statement of the general 
nature of the evidence or arguments they wish to present, the names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before 
August 15, 2016. Time allotted for each presentation may be limited. If 
the number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. The contact person will notify 
interested persons regarding their request to speak by August 16, 2016.
    Closed Committee Deliberations: On September 7, 2016, from 3:20 
p.m. to 4 p.m., the meeting will be closed to permit discussion where 
disclosure would constitute a clearly unwarranted invasion of personal 
privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of 
intramural research programs and make recommendations regarding 
personnel staffing decisions.
    Persons attending FDA's advisory committee meetings are advised 
that the

[[Page 51918]]

Agency is not responsible for providing access to electrical outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Janie Kim at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 1, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-18560 Filed 8-4-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices 51917 2. Type of Information Collection DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: Request: New collection (Request for a HUMAN SERVICES Agenda: On September 7, 2016, the new OMB control number); Title of committee will meet by teleconference. Information Collection: The PACE Food and Drug Administration In open session, the committee will hear Organization (PO) Monitoring and Audit updates of research programs in the [Docket No. FDA–2016–N–0001] Process in 42 CFR part 460; Use: Gene Transfer and Immunogenicity Historically, the Programs of All- Cellular, Tissue, and Gene Therapies Branch, Division of Cellular and Gene Inclusive Care for the Elderly (PACE) Advisory Committee; Notice of Meeting Therapies, Office of Cellular, Tissue, and Gene Therapies, Center for audit protocols have been included in AGENCY: Food and Drug Administration, Biologics Evaluation and Research. the Medicare Advantage (MA) and HHS. FDA intends to make background Medicare Part D audit protocol’s ACTION: Notice. material available to the public no later information collection request (CMS– than 2 business days before the meeting. 10191, OMB 0938–1000). However, in SUMMARY: The Food and Drug If FDA is unable to post the background examining previous submissions, we do Administration (FDA) announces a material on its Web site prior to the not believe that including it with the forthcoming public advisory committee meeting, the background material will MA and Part D audit protocols allowed meeting of the Cellular, Tissue, and be made publicly available at the for an accurate representation of the Gene Therapies Advisory Committee. location of the advisory committee PACE burden. Due to PACE audits being The general function of the committee is meeting, and the background material substantially different from our MA and to provide advice and recommendations will be posted on FDA’s Web site after Part D audits, we have separated the to the Agency on FDA’s regulatory the meeting. Background material is PACE audit protocols from the MA and issues. At least one portion of the available at http://www.fda.gov/ Part D protocols and created this meeting will be closed to the public. AdvisoryCommittees/Calendar/ information collection request which DATES: The meeting will be held on default.htm. Scroll down to the seeks OMB approval under a new September 7, 2016, from 1 p.m. to 4 appropriate advisory committee meeting control number. p.m. link. Procedure: On September 7, 2016, POs are required to comply with all ADDRESSES: FDA White Oak Campus, from 1 p.m. to 2:20 p.m., the meeting is PACE program requirements. The 10903 New Hampshire Ave., Bldg. 31 open to the public. Interested persons growth of these PACE organizations Conference Center, the Great Room (Rm. may present data, information, or views, forced CMS to develop an audit strategy 1503), Silver Spring, MD 20993–0002. orally or in writing, on issues pending to ensure we continue to obtain Answers to commonly asked questions before the committee. Written meaningful audit results. As a result, including information regarding special submissions may be made to the contact accommodations due to a disability, person on or before August 23, 2016. CMS’ audit strategy reflected a move to visitor parking, and transportation may Oral presentations from the public will a more targeted, data-driven and be accessed at: http://www.fda.gov/ be scheduled between approximately outcomes-based audit approach. We AdvisoryCommittees/AboutAdvisory focused on high-risk areas that have the 2:20 p.m. to 3:20 p.m. Those individuals Committees/ucm408555.htm. interested in making formal oral greatest potential for participant harm. FOR FURTHER INFORMATION CONTACT: presentations should notify the contact CMS has developed an audit protocol Janie Kim or Denise Royster, Center for person and submit a brief statement of and will post it to the CMS Web site Biologics Evaluation and Research, the general nature of the evidence or each year for use by POs to prepare for Food and Drug Administration, 10903 arguments they wish to present, the their audit. The data collected for audit New Hampshire Ave., Bldg. 71, Silver names and addresses of proposed is detailed in this protocol and the exact Spring, MD 20993–0002, 301–796–9016 participants, and an indication of the fields are located in the record layouts, or 240–402–8158, Janie.kim@ approximate time requested to make at the end of the protocol. In addition, fda.hhs.gov or Denise.royster@ their presentation on or before August a questionnaire will be distributed as fda.hhs.gov; or FDA Advisory 15, 2016. Time allotted for each part of our audit. This questionnaire is Committee Information Line, 1–800– presentation may be limited. If the also included in this package. Form 741–8138 (301–443–0572 in the number of registrants requesting to Number: CMS–10630 (OMB control Washington, DC area). A notice in the speak is greater than can be reasonably number: 0938–New); Frequency: Yearly; Federal Register about last minute accommodated during the scheduled Affected Public: Private sector (Business modifications that impact a previously open public hearing session, FDA may or other for-profits and Not-for-profits announced advisory committee meeting conduct a lottery to determine the institutions); Number of Respondents: cannot always be published quickly speakers for the scheduled open public 72; Total Annual Responses: 72; Total enough to provide timely notice. hearing session. The contact person will Annual Hours: 12,960. (For policy Therefore, you should always check the notify interested persons regarding their Agency’s Web site at http:// request to speak by August 16, 2016. questions regarding this collection www.fda.gov/AdvisoryCommittees/ Closed Committee Deliberations: On contact Caroline Zeman at 410–786– default.htm and scroll down to the September 7, 2016, from 3:20 p.m. to 4 0116.) appropriate advisory committee meeting p.m., the meeting will be closed to Dated: August 2, 2016. link, or call the advisory committee permit discussion where disclosure information line to learn about possible would constitute a clearly unwarranted mstockstill on DSK3G9T082PROD with NOTICES William N. Parham, III, Director, Paperwork Reduction Staff, Office modifications before coming to the invasion of personal privacy (5 U.S.C. of Strategic Operations and Regulatory meeting. For those unable to attend in 552b(c)(6)). The committee will discuss Affairs. person, the meeting will also be reports of intramural research programs [FR Doc. 2016–18662 Filed 8–4–16; 8:45 am] available via Webcast. The Webcast will and make recommendations regarding be available at the following link: personnel staffing decisions. BILLING CODE 4120–01–P https://collaboration.fda.gov/ Persons attending FDA’s advisory ctgtac0916/. committee meetings are advised that the VerDate Sep<11>2014 17:42 Aug 04, 2016 Jkt 238001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\05AUN1.SGM 05AUN1

51918 Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices Agency is not responsible for providing performed. For parking and security Category Cost access to electrical outlets. information, please refer to http:// FDA welcomes the attendance of the www.fda.gov/AboutFDA/ Industry Representative ........ $50 public at its advisory committee WorkingatFDA/BuildingsandFacilities/ Nonprofit Organization and meetings and will make every effort to WhiteOakCampusInformation/ Academic Other Than Uni- accommodate persons with disabilities. ucm241740.htm. versity of Maryland ............ 50 University of Maryland, Col- If you require accommodations due to a FOR FURTHER INFORMATION CONTACT: lege Park and Baltimore ... 0 disability, please contact Janie Kim at Federal Government ............. 0 least 7 days in advance of the meeting. Audrey Thomas, Office of Regulatory FDA is committed to the orderly Science and Innovation, Food and Drug Administration, 10903 New Hampshire Streaming Webcast of the Public conduct of its advisory committee Workshop: This public workshop will meetings. Please visit our Web site at Ave., Bldg. 1, Rm. 4220, Silver Spring, MD 20993–0002, 301–796–3520, also be Webcast. There is no registration http://www.fda.gov/Advisory fee for access to the workshop via the Committees/AboutAdvisoryCommittees/ Audrey.Thomas@fda.hhs.gov. Webcast, but registration is still ucm111462.htm for procedures on SUPPLEMENTARY INFORMATION: The required. Information regarding public conduct during advisory purpose of this public workshop is to registration and access to the Webcast committee meetings. provide an opportunity for relevant link is available at http://www.fda.gov/ Notice of this meeting is given under stakeholders including: Clinicians and ScienceResearch/SpecialTopics/ the Federal Advisory Committee Act (5 scientists from FDA and other RegulatoryScience/ucm507079.htm. If U.S.C. app. 2). government Agencies, academia, non- you have never attended a Connect Pro Dated: August 1, 2016. profit organizations, and industry to event before, test your connection at Janice M. Soreth, discuss use of pediatric master protocols https://collaboration.fda.gov/common/ for development of medical products for help/en/support/meeting_test.htm. To Acting Associate Commissioner, Special Medical Programs. children. Specifically, the workshop get a quick overview of the Connect Pro will present the current status of program, visit http://www.adobe.com/ [FR Doc. 2016–18560 Filed 8–4–16; 8:45 am] pediatric protocol development in the go/connectpro_overview. (FDA has BILLING CODE 4164–01–P United States, considerations for verified the Web site addresses in this pediatric protocol development document, but FDA is not responsible DEPARTMENT OF HEALTH AND internationally, and development of for any subsequent changes to the Web HUMAN SERVICES international consortia in this area. sites after this document publishes in Clinical trial design considerations and the Federal Register.) Food and Drug Administration the preliminary steps needed for Accommodations: Attendees are development of pediatric master responsible for their own hotel [Docket No. FDA–2016–N–0001] protocols, including the role of in vitro accommodations. If you need special Pediatric Master Protocols; Public diagnostic tests, will also be discussed. accommodations while at FDA’s White Workshop Finally, examples of pediatric master Oak Campus due to a disability, please protocol development for medical contact Shari Solomon at AGENCY: Food and Drug Administration, products with no, partial, and full Shari.Solomon@fda.hhs.gov at least 7 HHS. extrapolation of data from adults to days in advance. ACTION: Notice of public workshop. children will be presented. The Dated: August 1, 2016. workshop will include two panel SUMMARY: The Food and Drug sessions for interaction and discussion Leslie Kux, Administration (FDA), in collaboration among the speakers and attendees. Associate Commissioner for Policy. with the University of Maryland Center Agenda: The agenda is available at [FR Doc. 2016–18555 Filed 8–4–16; 8:45 am] of Excellence in Regulatory Science and http://www.fda.gov/ScienceResearch/ BILLING CODE 4164–01–P Innovation, is announcing a public SpecialTopics/RegulatoryScience/ workshop titled, ‘‘Pediatric Master ucm507079.htm (FDA has verified the Protocols’’. The objective of the Web site address, but FDA is not DEPARTMENT OF HEALTH AND workshop is to discuss regulatory and responsible for subsequent changes to HUMAN SERVICES scientific concerns related to pediatric the Web site after this document master protocols and clinical trial Food and Drug Administration publishes in the Federal Register). design considerations for these [Docket No. FDA–2016–N–0001] Registration: There is a registration fee protocols. In addition, applications of to attend this public workshop in- pediatric master protocols to specific National Mammography Quality person. Seats are limited and pediatric therapeutic areas will be Assurance Advisory Committee; registration will be on a first-come, first- presented. Notice of Meeting served basis. To register, please DATES: The public workshop will be complete registration online at http:// AGENCY: Food and Drug Administration, held on September 23, 2016, from 8:30 www.fda.gov/ScienceResearch/Special HHS. a.m. to 4:30 p.m. Topics/RegulatoryScience/ ACTION: Notice. ADDRESSES: The public workshop will ucm507079.htm (FDA has verified the be held at FDA’s White Oak Campus, Web site address, but FDA is not SUMMARY: The Food and Drug mstockstill on DSK3G9T082PROD with NOTICES 10903 New Hampshire Ave., Building responsible for subsequent changes to Administration (FDA) announces a 31 Conference Center, the Great Room the Web site after this document forthcoming public advisory committee (Rm. 1503), Silver Spring, MD 20993– publishes in the Federal Register). meeting of the National Mammography 0002. Entrance for the public meeting There will be no onsite registration. The Quality Assurance Advisory Committee. participants (non-FDA employees) is costs of registration, to attend in-person, The general function of the committee is through Building 1 where routine for different categories of attendees are to provide advice and recommendations security check procedures will be as follows: to the Agency on FDA’s regulatory VerDate Sep<11>2014 17:42 Aug 04, 2016 Jkt 238001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\05AUN1.SGM 05AUN1


Document Created: 2016-08-05 06:44:03
Document Modified: 2016-08-05 06:44:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe meeting will be held on September 7, 2016, from 1 p.m. to 4 p.m.
ContactJanie Kim or Denise Royster, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 301- 796-9016 or 240-402-8158, [email protected] or [email protected]; or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. For those unable to attend in person, the meeting will also be available via Webcast. The Webcast will be available at the following link: https://collaboration.fda.gov/ctgtac0916/.
FR Citation81 FR 51917 
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