82 FR 40770 - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 165 (August 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 165 (August 28, 2017)
| Page Range | 40770-40771 | |
| FR Document | 2017-18161 |
[Federal Register Volume 82, Number 165 (Monday, August 28, 2017)] [Notices] [Pages 40770-40771] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18161] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0001] Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. DATES: The meeting will be held on October 12, 2017, from 8:30 a.m. to 5 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. For those unable to attend in person, the meeting will also be Webcast and will be available at the following link: https://collaboration.fda.gov/ctgtac101217. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Prabhakara L. Atreya or Denise Royster, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver Spring, MD 20993-0002, 240-402-8006, [email protected] and 240-402-8158, [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 https://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. SUPPLEMENTARY INFORMATION: Agenda: On October 12, 2017, the CTGTAC will meet in an open session to discuss and make recommendations on the safety and effectiveness of biologics license application (BLA) for voretigene neparvovec (BLA 125610), submitted by Spark Therapeutics, Inc. The proposed indication (use) for this product is for the treatment of patients with vision loss due to confirmed biallelic RPE65 mutation- associated retinal dystrophy. 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 https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: 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 October 4, 2017. Oral presentations from the public will be scheduled between approximately 11:15 a.m. and 12:15 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 September 26, 2017. 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 September 27, 2017. Persons attending FDA's advisory committee meetings are advised that the 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 Prabhakara Atreya 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: https://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). [[Page 40771]] Dated: August 23, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-18161 Filed 8-25-17; 8:45 am] BILLING CODE 4164-01-P
![40770 Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices
Hours per Response: 5. DATES:The meeting will be held on location of the advisory committee
Total Burden Hours: 1,286,425. October 12, 2017, from 8:30 a.m. to 5 meeting, and the background material
Affected Public: Businesses or other p.m. will be posted on FDA’s Web site after
for-profit and not-for-profit institutions. the meeting. Background material is
Frequency: Annually. ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 available at https://www.fda.gov/
C. Public Comments Conference Center, the Great Room (Rm. AdvisoryCommittees/Calendar/
Public comments are particularly 1503) Silver Spring, MD 20993–0002. default.htm. Scroll down to the
invited on: Whether this collection of For those unable to attend in person, appropriate advisory committee meeting
information is necessary for the proper the meeting will also be Webcast and link.
performance of functions of the FAR, will be available at the following link: Procedure: Interested persons may
and whether it will have practical https://collaboration.fda.gov/ present data, information, or views,
utility; whether our estimate of the ctgtac101217. Answers to commonly orally or in writing, on issues pending
public burden of this collection of asked questions including information before the committee. Written
information is accurate, and based on regarding special accommodations due submissions may be made to the contact
valid assumptions and methodology; to a disability, visitor parking, and person on or before October 4, 2017.
ways to enhance the quality, utility, and transportation may be accessed at:
Oral presentations from the public will
clarity of the information to be https://www.fda.gov/
be scheduled between approximately
collected; and ways in which we can AdvisoryCommittees/
AboutAdvisoryCommittees/ 11:15 a.m. and 12:15 p.m. Those
minimize the burden of the collection of individuals interested in making formal
information on those who are to ucm408555.htm.
oral presentations should notify the
respond, through the use of appropriate FOR FURTHER INFORMATION CONTACT: contact person and submit a brief
technological collection techniques or Prabhakara L. Atreya or Denise Royster,
other forms of information technology. statement of the general nature of the
Center for Biologics Evaluation and evidence or arguments they wish to
Obtaining Copies of Proposals: Research, Food and Drug
Requesters may obtain a copy of the present, the names and addresses of
Administration, 10903 New Hampshire proposed participants, and an
information collection documents from Ave., Bldg. 71, Rm. 6306, Silver Spring,
the General Services Administration, indication of the approximate time
MD 20993–0002, 240–402–8006,
Regulatory Secretariat Division (MVCB), requested to make their presentation on
prabhakara.atreya@fda.hhs.gov and
1800 F Street NW., Washington, DC 240–402–8158, denise.royster@ or before September 26, 2017. Time
20405, telephone 202–501–4755. Please fda.hhs.gov, or FDA Advisory allotted for each presentation may be
cite OMB Control No. 9000–0180, Committee Information Line, 1–800– limited. If the number of registrants
Affirmative Procurement of Biobased 741–8138 (301–443–0572 in the requesting to speak is greater than can
Procurements Under Services and Washington, DC area). A notice in the be reasonably accommodated during the
Construction Contracts, in all Federal Register about last minute scheduled open public hearing session,
correspondence. modifications that impact a previously FDA may conduct a lottery to determine
Dated: August 22, 2017. announced advisory committee meeting the speakers for the scheduled open
Lorin S. Curit, cannot always be published quickly public hearing session. The contact
Director, Federal Acquisition Policy Division, enough to provide timely notice. person will notify interested persons
Office of Government-wide Acquisition Therefore, you should always check the regarding their request to speak by
Policy, Office of Acquisition Policy, Office Agency’s Web site at https:// September 27, 2017.
of Government-wide Policy. www.fda.gov/AdvisoryCommittees/ Persons attending FDA’s advisory
[FR Doc. 2017–18105 Filed 8–25–17; 8:45 am] default.htm and scroll down to the committee meetings are advised that the
BILLING CODE 6820–EP–P appropriate advisory committee meeting Agency is not responsible for providing
link, or call the advisory committee access to electrical outlets.
information line to learn about possible
DEPARTMENT OF HEALTH AND modifications before coming to the FDA welcomes the attendance of the
HUMAN SERVICES meeting. public at its advisory committee
meetings and will make every effort to
SUPPLEMENTARY INFORMATION:
Food and Drug Administration accommodate persons with disabilities.
Agenda: On October 12, 2017, the
If you require accommodations due to a
[Docket No. FDA–2017–N–0001] CTGTAC will meet in an open session
to discuss and make recommendations disability, please contact Prabhakara
Cellular, Tissue, and Gene Therapies on the safety and effectiveness of Atreya at least 7 days in advance of the
Advisory Committee; Notice of Meeting biologics license application (BLA) for meeting.
AGENCY: Food and Drug Administration, voretigene neparvovec (BLA 125610), FDA is committed to the orderly
HHS. submitted by Spark Therapeutics, Inc. conduct of its advisory committee
ACTION: Notice. The proposed indication (use) for this meetings. Please visit our Web site at:
product is for the treatment of patients https://www.fda.gov/
SUMMARY: The Food and Drug with vision loss due to confirmed AdvisoryCommittees/
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Administration (FDA) announces a biallelic RPE65 mutation-associated AboutAdvisoryCommittees/
forthcoming public advisory committee retinal dystrophy. ucm111462.htm for procedures on
meeting of the Cellular, Tissue, and FDA intends to make background public conduct during advisory
Gene Therapies Advisory Committee material available to the public no later committee meetings.
(CTGTAC). The general function of the than 2 business days before the meeting.
committee is to provide advice and If FDA is unable to post the background Notice of this meeting is given under
recommendations to the Agency on material on its Web site prior to the the Federal Advisory Committee Act (5
FDA’s regulatory issues. The meeting meeting, the background material will U.S.C. app. 2).
will be open to the public. be made publicly available at the
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![Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 40771
Dated: August 23, 2017. postmarked or the delivery service Submissions,’’ publicly viewable at
Anna K. Abram, acceptance receipt is on or before that https://www.regulations.gov or at the
Deputy Commissioner for Policy, Planning, date. Dockets Management Staff between 9
Legislation, and Analysis. Comments received on or before a.m. and 4 p.m., Monday through
[FR Doc. 2017–18161 Filed 8–25–17; 8:45 am] November 22, 2017, will be provided to Friday.
BILLING CODE 4164–01–P the committee. Comments received after • Confidential Submissions—To
that date will be taken into submit a comment with confidential
consideration by the Agency. information that you do not wish to be
DEPARTMENT OF HEALTH AND You may submit comments as made publicly available, submit your
HUMAN SERVICES follows: comments only as a written/paper
Electronic Submissions submission. You should submit two
Food and Drug Administration copies total. One copy will include the
Submit electronic comments in the information you claim to be confidential
[Docket No. FDA–2017–N–4561]
following way: with a heading or cover note that states
Bone, Reproductive and Urologic • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
Drugs Advisory Committee; Notice of https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
Meeting; Establishment of a Public instructions for submitting comments. Agency will review this copy, including
Docket; Request for Comments Comments submitted electronically, the claimed confidential information, in
including attachments, to https:// its consideration of comments. The
AGENCY: Food and Drug Administration, www.regulations.gov will be posted to
HHS. second copy, which will have the
the docket unchanged. Because your claimed confidential information
ACTION: Notice; establishment of a comment will be made public, you are redacted/blacked out, will be available
public docket; request for comments. solely responsible for ensuring that your for public viewing and posted on
comment does not include any https://www.regulations.gov. Submit
SUMMARY: The Food and Drug
confidential information that you or a both copies to the Dockets Management
Administration (FDA or Agency)
third party may not wish to be posted, Staff. If you do not wish your name and
announces a forthcoming public
such as medical information, your or contact information to be made publicly
advisory committee meeting of the
anyone else’s Social Security number, or available, you can provide this
Bone, Reproductive and Urologic Drugs
confidential business information, such information on the cover sheet and not
Advisory Committee. The general
as a manufacturing process. Please note in the body of your comments and you
function of the committee is to provide
that if you include your name, contact must identify this information as
advice and recommendations to the
information, or other information that ‘‘confidential.’’ Any information marked
Agency on FDA’s regulatory issues. The
meeting will be open to the public. FDA identifies you in the body of your as ‘‘confidential’’ will not be disclosed
is establishing a docket for public comments, that information will be except in accordance with 21 CFR 10.20
comment on this document. posted on https://www.regulations.gov. and other applicable disclosure law. For
• If you want to submit a comment
DATES: The public meeting will be held more information about FDA’s posting
with confidential information that you
on December 7, 2017, from 8 a.m. to 5 of comments to public dockets, see 80
do not wish to be made available to the
p.m. FR 56469, September 18, 2015, or access
public, submit the comment as a
ADDRESSES: FDA White Oak Campus, the information at: https://www.gpo.gov/
written/paper submission and in the
10903 New Hampshire Ave., Bldg. 31 fdsys/pkg/FR-2015-09-18/pdf/2015-
manner detailed (see ‘‘Written/Paper
Conference Center, the Great Room (Rm. 23389.pdf.
Submissions’’ and ‘‘Instructions’’).
1503), Silver Spring, MD 20993–0002. Docket: For access to the docket to
Answers to commonly asked questions Written/Paper Submissions read background documents or the
including information regarding special Submit written/paper submissions as electronic and written/paper comments
accommodations due to a disability, follows: received, go to https://
visitor parking, and transportation may • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
be accessed at: https://www.fda.gov/ written/paper submissions): Dockets docket number, found in brackets in the
AdvisoryCommittees/ Management Staff (HFA–305), Food and heading of this document, into the
AboutAdvisoryCommittees/ Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
ucm408555.htm. Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
FDA is establishing a docket for • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
public comment on this meeting. The submitted to the Dockets Management Rockville, MD 20852.
docket number is FDA–2017–N–4561. Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT:
The docket will close on December 6, well as any attachments, except for Kalyani Bhatt, Center for Drug
2017. Submit either electronic or information submitted, marked and Evaluation and Research, Food and
written comments on this public identified, as confidential, if submitted Drug Administration, 10903 New
meeting by December 6, 2017. Please as detailed in ‘‘Instructions.’’ Hampshire Ave., Bldg. 31, Rm. 2417,
note that late, untimely filed comments Instructions: All submissions received Silver Spring, MD 20993–0002, 301–
will not be considered. Electronic must include the Docket No. FDA– 796–9001, Fax: 301–847–8533,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
comments must be submitted on or 2017–N–4561 for ‘‘Bone, Reproductive kalyani.bhatt@fda.hhs.gov, or FDA
before December 6, 2017. The https:// and Urologic Drugs Advisory Advisory Committee Information Line,
www.regulations.gov electronic filing Committee; Notice of Meeting; 1–800–741–8138 (301–443–0572 in the
system will accept comments until Establishment of a Public Docket; Washington, DC area). A notice in the
midnight Eastern Time at the end of Request for Comments.’’ Received Federal Register about last minute
December 6, 2017. Comments received comments, those filed in a timely modifications that impact a previously
by mail/hand delivery/courier (for manner (see ADDRESSES), will be placed announced advisory committee meeting
written/paper submissions) will be in the docket and, except for those cannot always be published quickly
considered timely if they are submitted as ‘‘Confidential enough to provide timely notice.
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Document Created: 2017-08-28 11:30:00
Document Modified: 2017-08-28 11:30:00
| 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. | |
| Dates | The meeting will be held on October 12, 2017, from 8:30 a.m. to 5 p.m. | |
| Contact | Prabhakara L. Atreya or Denise Royster, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver Spring, MD 20993-0002, 240-402-8006, [email protected] and 240-402-8158, [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 https://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. | |
| FR Citation | 82 FR 40770 |
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