Tobacco Products Scientific Advisory Committee; Notice of Meeting, 11226-11227 [2017-03364]

Download as PDF 11226 Federal Register / Vol. 82, No. 33 / Tuesday, February 21, 2017 / Notices sradovich on DSK3GMQ082PROD with NOTICES SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization, and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products for human use among regulators around the world. The six founding members of the ICH are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA; and the Pharmaceutical Research and Manufacturers of America. The Standing Members of the ICH Association include Health Canada and Swissmedic. Any party eligible as a Member in accordance with the ICH Articles of Association can apply for membership in writing to the ICH Secretariat. The ICH Secretariat, which coordinates the preparation of documentation, operates as an international nonprofit organization and is funded by the Members of the ICH Association. The ICH Assembly is the overarching body of the Association and includes representatives from each of the ICH members and observers. In November 2016, the ICH Assembly endorsed the draft guidance entitled ‘‘Q11 Development and Manufacture of Drug Substances—Questions and Answers (regarding the selection and justification of starting materials)’’ and agreed that the guidance should be made available for public comment. The draft guidance is the product of the Q11 Quality Implementation Working Group of the ICH. The guidance consists of questions and answers that were developed to clarify the principles for selecting starting materials described in the ICH guidance ‘‘Q11 Development VerDate Sep<11>2014 17:15 Feb 17, 2017 Jkt 241001 and Manufacture of Drug Substances’’ published November 20, 2012 (77 FR 69634), and available online at http:// www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/Guidances/ UCM261078.pdf. The draft guidance provides guidance on selecting and justifying starting materials, in particular for the synthesis of chemical entity drug substances. Comments about this draft will be considered by FDA and the Quality Implementation Working Group. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. 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. Electronic Access Persons with access to the Internet may obtain the document at https:// www.regulations.gov, http:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, or http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm. Dated: February 14, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–03309 Filed 2–17–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0001] Tobacco Products Scientific Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee. 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 April 6, 2017, from 8:30 a.m. to 4:30 p.m. SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Tommy Douglas Conference Center, 10000 New Hampshire Ave., Silver Spring, Maryland 20903. 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: Caryn Cohen, Office of Science, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 1–877–287–1373, email: TPSAC@fda.hhs.gov. 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. SUPPLEMENTARY INFORMATION: Agenda: Under section 910(b)(2) (21 U.S.C. 387j(b)(2)) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA may refer applications for premarket review of new tobacco products (PMTA) to the Tobacco Products Scientific Advisory Committee (Committee). The FD&C Act also provides for mandatory referral of modified risk tobacco product applications (MRTPA) to the Committee under section 911(f)(1) (21 U.S.C. 387k (f)(1)). On April 6, 2017, FDA will present information to the Committee on the processes used in review of tobacco product applications, including premarket tobacco, substantial equivalence, and modified risk tobacco product applications. Topics will include the statutory standards applicable to the different types of applications, the scientific basis for review decisions, with a focus on PMTA and MRTPA, and the role of the Committee in the review process. 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 ADDRESSES: E:\FR\FM\21FEN1.SGM 21FEN1 sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 82, No. 33 / Tuesday, February 21, 2017 / Notices 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: 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 March 23, 2017. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 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 March 15, 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 March 16, 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 Caryn Cohen 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: February 15, 2017. Janice M. Soreth, Associate Commissioner for Special Medical Programs. [FR Doc. 2017–03364 Filed 2–17–17; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:15 Feb 17, 2017 Jkt 241001 11227 DEPARTMENT OF HEALTH AND HUMAN SERVICES manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Food and Drug Administration Written/Paper Submissions Submit written/paper submission 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– 2017–N–0595 for ‘‘Pediatric Postmarketing Pharmacovigilance and Drug Utilization Reviews’’ that have been posted on the FDA Web site at http://www.fda.gov/ AdvisoryCommittees/ CommitteesMeetingMaterials/ PediatricAdvisoryCommittee/ ucm510701.htm between September 17, 2016, and February 24, 2017, but will not be presented at the March 6–7, 2017 PAC meeting (82 FR 1345, January 5, 2017). 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 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 https://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’’ [Docket No. FDA–2017–N–0595] Pediatric Postmarketing Pharmacovigilance and Drug Utilization Reviews; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments related to the pediatric postmarketing pharmacovigilance and drug utilization reviews of products posted between September 17, 2016, and February 24, 2017, on the FDA Web site, but will not be presented at the March 6–7, 2017, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public. DATES: Submit either electronic or written comments by March 10, 2017. The docket will open on February 27, 2017, and remain open until March 10, 2017. ADDRESSES: You may submit your comments as follows: SUMMARY: 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, you 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 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\21FEN1.SGM 21FEN1

Agencies

[Federal Register Volume 82, Number 33 (Tuesday, February 21, 2017)]
[Notices]
[Pages 11226-11227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03364]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Tobacco Products Scientific 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 Tobacco Products Scientific 
Advisory Committee. 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 April 6, 2017, from 8:30 a.m. to 
4:30 p.m.

ADDRESSES: Tommy Douglas Conference Center, 10000 New Hampshire Ave., 
Silver Spring, Maryland 20903. 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: Caryn Cohen, Office of Science, Center 
for Tobacco Products, Food and Drug Administration, Document Control 
Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 
20993-0002, 1-877-287-1373, email: TPSAC@fda.hhs.gov. 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.

SUPPLEMENTARY INFORMATION: 
    Agenda: Under section 910(b)(2) (21 U.S.C. 387j(b)(2)) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA may refer 
applications for premarket review of new tobacco products (PMTA) to the 
Tobacco Products Scientific Advisory Committee (Committee). The FD&C 
Act also provides for mandatory referral of modified risk tobacco 
product applications (MRTPA) to the Committee under section 911(f)(1) 
(21 U.S.C. 387k (f)(1)). On April 6, 2017, FDA will present information 
to the Committee on the processes used in review of tobacco product 
applications, including premarket tobacco, substantial equivalence, and 
modified risk tobacco product applications. Topics will include the 
statutory standards applicable to the different types of applications, 
the scientific basis for review decisions, with a focus on PMTA and 
MRTPA, and the role of the Committee in the review process.
    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

[[Page 11227]]

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: 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 
March 23, 2017. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 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 March 15, 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 March 16, 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 Caryn Cohen 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: February 15, 2017.
Janice M. Soreth,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2017-03364 Filed 2-17-17; 8:45 am]
BILLING CODE 4164-01-P