81 FR 39053 - Tobacco Product Manufacturing Facility Visits
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 115 (June 15, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 115 (June 15, 2016)
| Page Range | 39053-39054 | |
| FR Document | 2016-14139 |
[Federal Register Volume 81, Number 115 (Wednesday, June 15, 2016)] [Notices] [Pages 39053-39054] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-14139] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0853] Tobacco Product Manufacturing Facility Visits AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA), Center for Tobacco Products (CTP) is announcing an invitation for participation in its Tobacco Product Manufacturing Facility Visits. This program is intended to give FDA staff an opportunity to visit facilities involved in the manufacturing of newly deemed tobacco products and their components and parts, including any related laboratory testing, and to observe the manufacturing operations of the tobacco industry. The purpose of this document is to invite parties interested in participating in Tobacco Product Manufacturing Facility Visits to submit requests to CTP. DATES: Submit either an electronic or written request for participation by August 15, 2016. See section IV of this document for information on requests for participation. ADDRESSES: If your facility is interested in participating in Tobacco Product Manufacturing Facility Visits, please submit a request either electronically to http://www.regulations.gov or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Matthew Brenner, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 877-287-1373, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31; 123 Stat. 1776) was signed into law, amending the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and giving FDA authority to regulate tobacco product manufacturing, distribution, and marketing. The new provisions include, among other things, the authority to issue regulations related to tobacco product manufacturing practice in order to protect the public health and to assure that tobacco products are in compliance with the FD&C Act. Specifically, section 906(e) of the FD&C Act (21 U.S.C. 387f(e)) provides that in applying manufacturing restrictions to tobacco, the Secretary shall prescribe regulations (which may differ based on the type of tobacco product involved) requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a tobacco product), packing, and storage of a tobacco product conform to current good manufacturing practice, or hazard analysis and critical control point methodology. CTP is instituting Tobacco Product Manufacturing Facility Visits to provide FDA staff with the opportunity to:Observe tobacco product manufacturing operations--from the receipt of raw materials to the distribution of newly deemed tobacco products, and Learn about the manufacturing practices and processes unique to your facility and newly deemed tobacco products. This program will also inform FDA staff as they implement the tobacco provisions of the FD&C Act. II. Description of the Tobacco Product Manufacturing Facility Visits In this program, groups of FDA staff plan to observe the following facilities and their operations: Manufacturing facilities, including establishments that process, package, label, and distribute different types of newly deemed tobacco products (e.g., dissolvable products, gels, cigars, pipe tobacco, waterpipe tobacco products, and electronic nicotine delivery systems (ENDS) (including e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, and electronic pipes) and liquid nicotine and flavors) (see 81 FR 28973, May 10, 2016), Laboratory facilities that perform tobacco testing (whether third-party or in-house), and Manufacturing facilities for tobacco products for further manufacturing into finished tobacco products (including, but not limited to, components, parts, flavors, casings, e-liquids). Please note that Tobacco Product Manufacturing Facility Visits are not intended to include or replace official FDA inspections of facilities to determine compliance with the FD&C Act; rather, these facility visits are meant to educate FDA staff and improve their understanding of the tobacco industry and its manufacturing operations. III. Site Selection CTP plans to select sites from one or more of each of the following categories: Dissolvable products, Gels, Cigars, Pipe tobacco, Waterpipe tobacco products, ENDS (including e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, and electronic pipes) and liquid nicotine and flavors, Tobacco laboratories, Importers of finished tobacco products, Distributors and wholesalers of regulated tobacco products, and/or Manufacturers of tobacco products for further manufacturing into finished tobacco products (including, but not limited to, components, parts, flavors, casings, e-liquids). Final site selections will be based on the availability of CTP funds and resources for the relevant fiscal year, as well as the following factors, as applicable: (1) Compliance status of the requesting facility and affiliated firm; (2) whether the requesting facility or affiliated firm, if applicable, has a significant request or marketing application or submission pending with FDA; and (3) whether the requesting facility will be engaged in active manufacturing or processing during the proposed time of the visit. All travel expenses associated with Tobacco Product Manufacturer Facility Visits will be the responsibility of CTP. IV. Requests for Participation The request for participation should include the following identification information: The name and contact information (including address, phone number, and email) of your point of contact for the request; [[Page 39054]] The physical address(es) of the site(s) for which you are submitting a request; The type of processes (e.g., manufacturing, laboratory practices, mixing, packaging, labeling, and distribution activities) performed at your facility; The type of tobacco products tested, processed, or manufactured at your facility; and A proposed program agenda. Identify requests for participation with the docket number found in brackets in the heading of this document. Received requests are available for public examination in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. Dated: June 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-14139 Filed 6-14-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 115 / Wednesday, June 15, 2016 / Notices 39053
Obtaining Copies of Proposals: Hampshire Ave., Silver Spring, MD and flavors) (see 81 FR 28973, May 10,
Requesters may obtain a copy of the 20993–0002, 877–287–1373, email: 2016),
information collection documents from CTPRegulations@fda.hhs.gov. • Laboratory facilities that perform
the General Services Administration, SUPPLEMENTARY INFORMATION: tobacco testing (whether third-party or
Regulatory Secretariat Division (MVCB), in-house), and
1800 F Street, Washington, DC 20405, I. Background • Manufacturing facilities for tobacco
telephone 202–501–4755. Please cite On June 22, 2009, the Family products for further manufacturing into
OMB Control No. 9000–0056, Report of Smoking Prevention and Tobacco finished tobacco products (including,
Shipment, in all correspondence. Control Act (Pub. L. 111–31; 123 Stat. but not limited to, components, parts,
1776) was signed into law, amending flavors, casings, e-liquids).
Dated: June 9, 2016. Please note that Tobacco Product
the Federal Food, Drug, and Cosmetic
Lorin S. Curit, Manufacturing Facility Visits are not
Act (the FD&C Act) and giving FDA
Director, Federal Acquisition Policy Division, authority to regulate tobacco product intended to include or replace official
Office of Governmentwide Acquisition Policy, FDA inspections of facilities to
manufacturing, distribution, and
Office of Acquisition Policy, Office of determine compliance with the FD&C
Governmentwide Policy. marketing. The new provisions include,
among other things, the authority to Act; rather, these facility visits are
[FR Doc. 2016–14119 Filed 6–14–16; 8:45 am] meant to educate FDA staff and improve
issue regulations related to tobacco
BILLING CODE 6820–EP–P
product manufacturing practice in order their understanding of the tobacco
to protect the public health and to industry and its manufacturing
assure that tobacco products are in operations.
DEPARTMENT OF HEALTH AND compliance with the FD&C Act.
HUMAN SERVICES III. Site Selection
Specifically, section 906(e) of the FD&C
Act (21 U.S.C. 387f(e)) provides that in CTP plans to select sites from one or
Food and Drug Administration more of each of the following categories:
applying manufacturing restrictions to
• Dissolvable products,
[Docket No. FDA–2012–N–0853] tobacco, the Secretary shall prescribe • Gels,
regulations (which may differ based on • Cigars,
Tobacco Product Manufacturing the type of tobacco product involved) • Pipe tobacco,
Facility Visits requiring that the methods used in, and • Waterpipe tobacco products,
AGENCY: Food and Drug Administration, the facilities and controls used for, the • ENDS (including e-cigarettes, e-
HHS. manufacture, preproduction design hookah, e-cigars, vape pens, advanced
ACTION: Notice. validation (including a process to assess refillable personal vaporizers, and
the performance of a tobacco product), electronic pipes) and liquid nicotine
SUMMARY: The Food and Drug packing, and storage of a tobacco and flavors,
Administration (FDA), Center for product conform to current good • Tobacco laboratories,
Tobacco Products (CTP) is announcing manufacturing practice, or hazard • Importers of finished tobacco
an invitation for participation in its analysis and critical control point products,
Tobacco Product Manufacturing Facility methodology. • Distributors and wholesalers of
Visits. This program is intended to give CTP is instituting Tobacco Product regulated tobacco products, and/or
FDA staff an opportunity to visit Manufacturing Facility Visits to provide • Manufacturers of tobacco products
facilities involved in the manufacturing FDA staff with the opportunity to: for further manufacturing into finished
of newly deemed tobacco products and • Observe tobacco product tobacco products (including, but not
their components and parts, including manufacturing operations—from the limited to, components, parts, flavors,
any related laboratory testing, and to receipt of raw materials to the casings, e-liquids).
observe the manufacturing operations of distribution of newly deemed tobacco Final site selections will be based on
the tobacco industry. The purpose of products, and the availability of CTP funds and
this document is to invite parties • Learn about the manufacturing resources for the relevant fiscal year, as
interested in participating in Tobacco practices and processes unique to your well as the following factors, as
Product Manufacturing Facility Visits to facility and newly deemed tobacco applicable: (1) Compliance status of the
submit requests to CTP. products. requesting facility and affiliated firm; (2)
This program will also inform FDA whether the requesting facility or
DATES: Submit either an electronic or
staff as they implement the tobacco affiliated firm, if applicable, has a
written request for participation by
provisions of the FD&C Act. significant request or marketing
August 15, 2016. See section IV of this
application or submission pending with
document for information on requests II. Description of the Tobacco Product
FDA; and (3) whether the requesting
for participation. Manufacturing Facility Visits
facility will be engaged in active
ADDRESSES: If your facility is interested In this program, groups of FDA staff manufacturing or processing during the
in participating in Tobacco Product plan to observe the following facilities proposed time of the visit. All travel
Manufacturing Facility Visits, please and their operations: expenses associated with Tobacco
submit a request either electronically to • Manufacturing facilities, including Product Manufacturer Facility Visits
http://www.regulations.gov or in writing establishments that process, package, will be the responsibility of CTP.
to the Division of Dockets Management label, and distribute different types of
(HFA–305), Food and Drug newly deemed tobacco products (e.g., IV. Requests for Participation
Administration, 5630 Fishers Lane, Rm.
ehiers on DSK5VPTVN1PROD with NOTICES
dissolvable products, gels, cigars, pipe The request for participation should
1061, Rockville, MD 20852. tobacco, waterpipe tobacco products, include the following identification
FOR FURTHER INFORMATION CONTACT: and electronic nicotine delivery systems information:
Matthew Brenner, Center for Tobacco (ENDS) (including e-cigarettes, e- • The name and contact information
Products, Food and Drug hookah, e-cigars, vape pens, advanced (including address, phone number, and
Administration, Document Control refillable personal vaporizers, and email) of your point of contact for the
Center, Bldg. 71, Rm. G335, 10903 New electronic pipes) and liquid nicotine request;
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![39054 Federal Register / Vol. 81, No. 115 / Wednesday, June 15, 2016 / Notices
• The physical address(es) of the • Federal eRulemaking Portal: http:// submission. You should submit two
site(s) for which you are submitting a www.regulations.gov. Follow the copies total. One copy will include the
request; instructions for submitting comments. information you claim to be confidential
• The type of processes (e.g., Comments submitted electronically, with a heading or cover note that states
manufacturing, laboratory practices, including attachments, to http:// ‘‘THIS DOCUMENT CONTAINS
mixing, packaging, labeling, and www.regulations.gov will be posted to CONFIDENTIAL INFORMATION.’’ The
distribution activities) performed at the docket unchanged. Because your Agency will review this copy, including
your facility; comment will be made public, you are the claimed confidential information, in
• The type of tobacco products tested, solely responsible for ensuring that your its consideration of comments. The
processed, or manufactured at your comment does not include any second copy, which will have the
facility; and confidential information that you or a claimed confidential information
• A proposed program agenda. third party may not wish to be posted, redacted/blacked out, will be available
Identify requests for participation such as medical information, your or for public viewing and posted on http://
with the docket number found in anyone else’s Social Security number, or www.regulations.gov. Submit both
brackets in the heading of this confidential business information, such copies to the Division of Dockets
document. Received requests are as a manufacturing process. Please note Management. If you do not wish your
available for public examination in the that if you include your name, contact name and contact information to be
Division of Dockets Management (see information, or other information that made publicly available, you can
ADDRESSES) between 9 a.m. and 4 p.m., identifies you in the body of your provide this information on the cover
Monday through Friday. comments, that information will be sheet and not in the body of your
Dated: June 9, 2016. posted on http://www.regulations.gov. comments and you must identify this
Leslie Kux, • If you want to submit a comment information as ‘‘confidential.’’ Any
Associate Commissioner for Policy. with confidential information that you information marked as ‘‘confidential’’
[FR Doc. 2016–14139 Filed 6–14–16; 8:45 am]
do not wish to be made available to the will not be disclosed except in
BILLING CODE 4164–01–P
public, submit the comment as a accordance with 21 CFR 10.20 and other
written/paper submission and in the applicable disclosure law. For more
manner detailed (see ‘‘Written/Paper information about FDA’s posting of
DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’). comments to public dockets, see 80 FR
HUMAN SERVICES Written/Paper Submissions 56469, September 18, 2015, or access
the information at: http://www.fda.gov/
Food and Drug Administration Submit written/paper submissions as
regulatoryinformation/dockets/
follows:
[Docket No. FDA–2004–N–0451] • Mail/Hand delivery/Courier (for default.htm.
written/paper submissions): Division of Docket: For access to the docket to
Food and Drug Administration read background documents or the
Dockets Management (HFA–305), Food
Modernization Act of 1997: electronic and written/paper comments
and Drug Administration, 5630 Fishers
Modifications to the List of Recognized received, go to http://
Lane, Rm. 1061, Rockville, MD 20852.
Standards, Recognition List Number: • For written/paper comments www.regulations.gov and insert the
042 submitted to the Division of Dockets docket number, found in brackets in the
AGENCY: Food and Drug Administration, Management, FDA will post your heading of this document, into the
HHS. comment, as well as any attachments, ‘‘Search’’ box and follow the prompts
except for information submitted, and/or go to the Division of Dockets
ACTION: Notice.
marked and identified, as confidential, Management, 5630 Fishers Lane, Rm.
SUMMARY: The Food and Drug if submitted as detailed in 1061, Rockville, MD 20852.
Administration (FDA or Agency) is ‘‘Instructions.’’ An electronic copy of Recognition List
announcing a publication containing Instructions: All submissions received Number: 042 is available on the Internet
modifications the Agency is making to must include the Docket No. FDA– at http://www.fda.gov/MedicalDevices/
the list of standards FDA recognizes for 2004–N–0451 for ‘‘Food and Drug DeviceRegulationandGuidance/
use in premarket reviews (FDA Administration Modernization Act of Standards/ucm123792.htm. See section
Recognized Consensus Standards). This 1997: Modifications to the List of VI of this document for electronic access
publication, entitled ‘‘Modifications to Recognized Standards, Recognition List to the searchable database for the
the List of Recognized Standards, Number: 042.’’ Received comments will current list of FDA recognized
Recognition List Number: 042’’ be placed in the docket and, except for consensus standards, including
(Recognition List Number: 042), will those submitted as ‘‘Confidential Recognition List Number: 042
assist manufacturers who elect to Submissions,’’ publicly viewable at modifications and other standards
declare conformity with consensus http://www.regulations.gov or at the related information. Submit written
standards to meet certain requirements Division of Dockets Management requests for a single hard copy of the
for medical devices. between 9 a.m. and 4 p.m., Monday document entitled ‘‘Modifications to the
DATES: Submit electronic or written through Friday. FDA will consider any List of Recognized Standards,
comments concerning this document at comments received in determining Recognition List Number: 042’’ to the
any time. These modifications to the list whether to amend the current listing of Division of Industry and Consumer
of recognized standards are effective modifications to the list of recognized Education, Center for Devices and
ehiers on DSK5VPTVN1PROD with NOTICES
June 15, 2016. standards, Recognition List Number: Radiological Health, Food and Drug
ADDRESSES: You may submit comments 042. Administration, 10903 New Hampshire
as follows: • Confidential Submissions—To Ave., Bldg. 66, Rm. 4613, Silver Spring,
submit a comment with confidential MD 20993–0002. Send one self-
Electronic Submissions information that you do not wish to be addressed adhesive label to assist that
Submit electronic comments in the made publicly available, submit your office in processing your request, or fax
following way: comments only as a written/paper your request to 301–847–8149.
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Document Created: 2016-06-15 02:21:20
Document Modified: 2016-06-15 02:21:20
| 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 | Submit either an electronic or written request for participation by August 15, 2016. See section IV of this document for information on requests for participation. | |
| Contact | Matthew Brenner, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 877-287-1373, email: [email protected] | |
| FR Citation | 81 FR 39053 |
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