81 FR 8967 - Waterpipes and Waterpipe Tobacco; Public Workshop; Establishment of a Public Docket
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 35 (February 23, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 35 (February 23, 2016)
| Page Range | 8967-8969 | |
| FR Document | 2016-03712 |
[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)] [Notices] [Pages 8967-8969] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03712] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0173] Waterpipes and Waterpipe Tobacco; Public Workshop; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; establishment of docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is announcing a public workshop to gather scientific information on waterpipes and waterpipe tobacco and to identify areas of research that may inform CTP's regulation of these tobacco products. The workshop will include presentations and panel discussions about the current state of the science, and will focus on product use and design, smoke constituents, environmental impacts, and the impact of marketing these products on population health, including on both users and nonusers. FDA is also opening a public docket to receive data, information, and comments on this topic. DATES: The public workshop will be held on March 17, 2016, from 8:30 a.m. to 5 p.m. and on March 18, 2016, from 8:30 a.m. to 4 p.m. Individuals who wish to attend the public workshop must register by February 25, 2016. Submit written or electronic comments to Docket No. FDA-2016-N-0173 by April 29, 2016. ADDRESSES: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is [[Page 8968]] through Building 1 where routine security check procedures will be performed. For parking, transportation, security, and information regarding special accommodations due to a disability, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. You may submit comments as follows: 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-2016-N-0173 for ``Waterpipes and Waterpipe Tobacco; Public Workshop; Establishment of a Public Docket.'' 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. 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 protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing a public workshop to gather scientific information and stimulate discussion among scientists about waterpipes and waterpipe tobacco. The workshop will focus on waterpipe tobacco product toxic emissions and exposure to harmful and potentially harmful constituents including: Second hand exposure, design and environmental concerns, prevalence, perception, use pattern, addiction, individual and population health. FDA is interested in gathering scientific information from individuals with a broad range of backgrounds on the scientific topics to be discussed at the workshop. Information related to workshop presentations and discussion topics, including specific questions to be addressed at the workshop, can be found at http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm. II. Registration To Attend the Workshop If you wish to attend the workshop in person or by Webcast, you must register by submitting either an electronic or written request no later than February 25, 2016. Please submit electronic requests at https://www.surveymonkey.com/r/Waterpipes2016. Persons without Internet access may send written requests for registration to Caryn Cohen (see FOR FURTHER INFORMATION CONTACT). Requests for registration must include the prospective attendee's name, title, affiliation, address, email address if available, and telephone number. Registration is free and you may register to either attend in-person or view the live Webcast. Both seating and viewership are limited, so early registration is recommended. FDA may limit the number of registrants from a single organization, as well as the total number of participants, if registration reaches full capacity. For those registrants with Internet access, confirmation of registration will be emailed to you no later March 1, 2016. Onsite registration may be allowed if space is available. If registration reaches maximum capacity, FDA will post a notice closing registration at http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm. If you need special accommodations due to a disability, please contact Caryn Cohen (see FOR FURTHER INFORMATION CONTACT) no later than March 10, 2016. III. Oral Presentations by Members of the Public This workshop includes a public comment session. Persons wishing to present during the public comment session must make this request at the time of registration and should identify the topic they wish to address from among those topics under consideration. [[Page 8969]] FDA will do its best to accommodate requests to present. FDA urges individuals and organizations with common interests to consolidate or coordinate their comments, and request a single time for a joint presentation. For those requesters with Internet access, Caryn Cohen (see FOR FURTHER INFORMATION CONTACT) will email you regarding your request to speak by March 1, 2016. IV. Transcripts Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at http://www.fda.gov. It will also be available after the workshop at http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm as soon as the official transcript is finalized. Dated: February 18, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-03712 Filed 2-22-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Notices 8967
marked and identified, as confidential, information on electronic access to the of ‘‘Design Considerations and Pre-
if submitted as detailed in guidance. Submit written requests for a market Submission Recommendations
‘‘Instructions.’’ single hard copy of the draft guidance for Interoperable Medical Devices’’ may
Instructions: All submissions received document entitled ‘‘Design send an email request to CDRH-
must include the Docket No. FDA– Considerations and Pre-market Guidance@fda.hhs.gov to receive an
2015–D–4852 for ‘‘Design Submission Recommendations for electronic copy of the document. Please
Considerations and Pre-market Interoperable Medical Devices’’ to the use the document number 1500015 to
Submission Recommendations for Office of the Center Director, Guidance identify the guidance you are
Interoperable Medical Devices.’’ and Policy Development, Center for requesting.
Received comments will be placed in Devices and Radiological Health, Food Dated: February 18, 2016.
the docket and, except for those and Drug Administration, 10903 New Leslie Kux,
submitted as ‘‘Confidential Hampshire Ave., Bldg. 66, Rm. 5431,
Submissions,’’ publicly viewable at Associate Commissioner for Policy.
Silver Spring, MD 20993–0002; or the
http://www.regulations.gov or at the [FR Doc. 2016–03696 Filed 2–22–16; 8:45 am]
Office of Communication, Outreach, and
Division of Dockets Management Development, Center for Biologics BILLING CODE 4164–01–P
between 9 a.m. and 4 p.m., Monday Evaluation and Research, Food and
through Friday. Drug Administration, 10903 New
• Confidential Submissions—To Hampshire Ave., Bldg. 71, Rm. 3128,
DEPARTMENT OF HEALTH AND
submit a comment with confidential HUMAN SERVICES
Silver Spring, MD 20993–0002. Send
information that you do not wish to be one self-addressed adhesive label to
made publicly available, submit your Food and Drug Administration
assist that office in processing your
comments only as a written/paper request. [Docket No. FDA–2016–N–0173]
submission. You should submit two
copies total. One copy will include the FOR FURTHER INFORMATION CONTACT: Waterpipes and Waterpipe Tobacco;
information you claim to be confidential Heather Agler, Center for Devices and Public Workshop; Establishment of a
with a heading or cover note that states Radiological Health, Food and Drug Public Docket
‘‘THIS DOCUMENT CONTAINS Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5570, Silver Spring, AGENCY: Food and Drug Administration,
CONFIDENTIAL INFORMATION.’’ The HHS.
Agency will review this copy, including MD 20993–0002, 301–796–6340; or
the claimed confidential information, in Stephen Ripley, Center for Biologics ACTION: Notice of public workshop;
its consideration of comments. The Evaluation and Research, Food and establishment of docket; request for
second copy, which will have the Drug Administration, 10903 New comments.
claimed confidential information Hampshire Ave., Bldg. 71, Rm. 7301, SUMMARY: The Food and Drug
redacted/blacked out, will be available Silver Spring, MD 20993–0002, 240– Administration (FDA), Center for
for public viewing and posted on 402–7911. Tobacco Products (CTP), is announcing
http://www.regulations.gov. Submit SUPPLEMENTARY INFORMATION: a public workshop to gather scientific
both copies to the Division of Dockets information on waterpipes and
I. Background
Management. If you do not wish your waterpipe tobacco and to identify areas
name and contact information to be In the Federal Register of January 26, of research that may inform CTP’s
made publicly available, you can 2016 (81 FR 4303), FDA published a regulation of these tobacco products.
provide this information on the cover notice announcing the availability of a The workshop will include
sheet and not in the body of your draft guidance entitled ‘‘Design presentations and panel discussions
comments and you must identify this Considerations and Premarket about the current state of the science,
information as ‘‘confidential.’’ Any Submission Recommendations for and will focus on product use and
information marked as ‘‘confidential’’ Interoperable Medical Devices’’ with a design, smoke constituents,
will not be disclosed except in 60-day comment period to request environmental impacts, and the impact
accordance with 21 CFR 10.20 and other comments. FDA is extending the of marketing these products on
applicable disclosure law. For more comment period for the draft guidance population health, including on both
information about FDA’s posting of for 30 days, until April 28, 2016. The users and nonusers. FDA is also opening
comments to public dockets, see 80 FR Agency believes that a 30-day extension a public docket to receive data,
56469, September 18, 2015, or access will allow adequate time for interested information, and comments on this
the information at: http://www.fda.gov/ persons to submit comments. topic.
regulatoryinformation/dockets/
II. Electronic Access DATES: The public workshop will be
default.htm.
Docket: For access to the docket to Persons interested in obtaining a copy held on March 17, 2016, from 8:30 a.m.
read background documents or the of the draft guidance may do so by to 5 p.m. and on March 18, 2016, from
electronic and written/paper comments downloading an electronic copy from 8:30 a.m. to 4 p.m. Individuals who
received, go to http:// the Internet. A search capability for all wish to attend the public workshop
www.regulations.gov and insert the Center for Devices and Radiological must register by February 25, 2016.
docket number, found in brackets in the Health guidance documents is available Submit written or electronic comments
heading of this document, into the at http://www.fda.gov/MedicalDevices/ to Docket No. FDA–2016–N–0173 by
April 29, 2016.
mstockstill on DSK4VPTVN1PROD with NOTICES
‘‘Search’’ box and follow the prompts DeviceRegulationandGuidance/
and/or go to the Division of Dockets GuidanceDocuments/default.htm. ADDRESSES: The public workshop will
Management, 5630 Fishers Lane, Rm. Guidance documents are also available be held at the FDA White Oak Campus,
1061, Rockville, MD 20852. at http://www.fda.gov/BiologicsBlood 10903 New Hampshire Ave., Bldg. 31
An electronic copy of the guidance Vaccines/GuidanceCompliance Conference Center, the Great Room (Rm.
document is available for download RegulatoryInformation/default.htm or 1503A), Silver Spring, MD 20993.
from the Internet. See the http://www.regulations.gov. Persons Entrance for the public workshop
SUPPLEMENTARY INFORMATION section for unable to download an electronic copy participants (non-FDA employees) is
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![Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Notices 8969
FDA will do its best to accommodate 777–2705, or by email at regulations at 42 CFR part 405 subparts
requests to present. FDA urges amanda.axeen@hhs.gov. I and J; part 417, subpart Q; part 422,
individuals and organizations with SUPPLEMENTARY INFORMATION: subpart M; part 423, subparts M and U;
common interests to consolidate or and part 478, subpart B. As noted above,
coordinate their comments, and request I. Background OMHA administers the nationwide
a single time for a joint presentation. For The Office of Medicare Hearings and Administrative Law Judge hearing
those requesters with Internet access, Appeals (OMHA), a staff division within program in accordance with these
Caryn Cohen (see FOR FURTHER the Office of the Secretary of the U.S. statutes and applicable regulations. As
INFORMATION CONTACT) will email you Department of Health and Human part of that effort, OMHA is establishing
regarding your request to speak by Services (HHS), administers the a manual, the OMHA Case Processing
March 1, 2016. nationwide Administrative Law Judge Manual (OCPM). Through the OCPM,
hearing program for Medicare claim, the OMHA Chief Administrative Law
IV. Transcripts organization and coverage Judge establishes the day-to-day
Please be advised that as soon as a determination, and entitlement appeals procedures for carrying out adjudicative
transcript is available, it will be under sections 1869, 1155, functions, in accordance with
accessible at http:// 1876(c)(5)(B), 1852(g)(5), and 1860D– applicable statutes, regulations and
www.regulations.gov. It may be viewed 4(h) of the Social Security Act (the Act). OMHA directives. The OCPM provides
at the Division of Dockets Management OMHA ensures that Medicare direction for processing appeals at the
(HFA–305), Food and Drug beneficiaries and the providers and OMHA level of adjudication for
Administration, 5630 Fishers Lane, Rm. suppliers that furnish items or services Medicare Part A and B claims; Part C
1061, Rockville, MD 20852. A transcript to Medicare beneficiaries, as well as organization determinations; Part D
will also be available in either hardcopy Medicare Advantage Organizations coverage determinations; and SSA
or on CD–ROM, after submission of a (MAOs) and Medicaid State Agencies, eligibility and entitlement, Part B late
Freedom of Information request. The have a fair and impartial forum to enrollment penalty, and IRMAA
Freedom of Information office address is address disagreements with Medicare determinations.
available on the Agency’s Web site at coverage and payment determinations Section 1871(c) of the Act requires
http://www.fda.gov. It will also be made by Medicare contractors, MAOs, that we publish a list of all Medicare
available after the workshop at http:// or Part D Plan Sponsors (PDPSs), and manual instructions, interpretive rules,
www.fda.gov/TobaccoProducts/ determinations related to Medicare statements of policy, and guidelines of
NewsEvents/ucm238308.htm as soon as eligibility and entitlement, Part B late general applicability not issued as
the official transcript is finalized. enrollment penalty, and income-related regulations at least every 3 months in
monthly adjustment amounts (IRMAA) the Federal Register.
Dated: February 18, 2016.
made by the Social Security
Leslie Kux, II. Format for the Quarterly Issuance
Administration (SSA).
Associate Commissioner for Policy. Notices
The Medicare claim, organization and
[FR Doc. 2016–03712 Filed 2–22–16; 8:45 am] coverage determination appeals This quarterly notice provides the
BILLING CODE 4164–01–P processes consist of four levels of specific updates to the OCPM that have
administrative review, and a fifth level occurred in the 3-month period. A
of review with the Federal district hyperlink to the available chapters on
DEPARTMENT OF HEALTH AND courts after administrative remedies the OMHA Web site is provided below.
HUMAN SERVICES under HHS regulations have been The OMHA Web site contains the most
exhausted. The first two levels of review current, up-to-date chapters and
[OMHA–1503–N] are administered by the Centers for revisions to chapters, and will be
Medicare & Medicaid Services (CMS) available earlier than we publish our
Medicare Program; Administrative Law and conducted by Medicare contractors quarterly notice. We believe the OMHA
Judge Hearing Program for Medicare for claim appeals, by MAOs and an Web site list provides more timely
Claim and Entitlement Appeals; independent review entity for Part C access to the current OCPM chapters for
Quarterly Listing of Program organization determination appeals, or those involved in the Medicare claim,
Issuances—October Through by PDPSs and an independent review organization and coverage
December 2015 entity for Part D coverage determination determination and entitlement appeals
appeals. The third level of review is processes. We also believe the Web site
AGENCY: Office of Medicare Hearings administered by OMHA and conducted offers the public a more convenient tool
and Appeals (OMHA), HHS. by Administrative Law Judges. The for real time access to current OCPM
ACTION: Notice. fourth level of review is administered by provisions. In addition, OMHA has a
the HHS Departmental Appeals Board listserv to which the public can
SUMMARY: This quarterly notice lists of (DAB) and conducted by the Medicare subscribe to receive immediate
the OMHA Case Processing Manual Appeals Council. In addition, OMHA notification of any updates to the
(OCPM) manual instructions that were and the DAB administer the second and OMHA Web site. This listserv avoids
published from October through third levels of appeal, respectively, for the need to check the OMHA Web site,
December, 2015. This manual Medicare eligibility, entitlement, Part B as update notifications are sent to
standardizes the day-to-day procedures late enrollment penalty, and IRMAA subscribers as they occur. If accessing
for carrying out adjudicative functions,
mstockstill on DSK4VPTVN1PROD with NOTICES
reconsiderations made by SSA; a fourth the OMHA Web site proves to be
in accordance with applicable statutes, level of review with the Federal district difficult, the contact person listed above
regulations and OMHA directives, and courts is available after administrative can provide the information.
gives OMHA staff direction for remedies within SSA and HHS have
processing appeals at the OMHA level been exhausted. III. How To Use the Notice
of adjudication. Sections 1869, 1155, 1876(c)(5)(B), This notice lists the OCPM chapters
FOR FURTHER INFORMATION CONTACT: 1852(g)(5), and 1860D–4(h) of the Act and subjects published during the
Amanda Axeen, by telephone at (571) are implemented through the quarter covered by the notice so the
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Document Created: 2018-02-02 14:33:08
Document Modified: 2018-02-02 14:33:08
| 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 workshop; establishment of docket; request for comments. | |
| Dates | The public workshop will be held on March 17, 2016, from 8:30 a.m. to 5 p.m. and on March 18, 2016, from 8:30 a.m. to 4 p.m. Individuals who wish to attend the public workshop must register by February 25, 2016. Submit written or electronic comments to Docket No. FDA-2016-N-0173 by April 29, 2016. | |
| 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 protected] | |
| FR Citation | 81 FR 8967 |
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