82 FR 37459 - Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 153 (August 10, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 153 (August 10, 2017)
| Page Range | 37459-37461 | |
| FR Document | 2017-16839 |
[Federal Register Volume 82, Number 153 (Thursday, August 10, 2017)] [Notices] [Pages 37459-37461] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16839] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-2834] Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule.'' This guidance is intended to assist persons who manufacture, package, sell, offer to sell, distribute, or import for sale and distribution within the United States newly regulated tobacco products, roll-your-own (RYO) tobacco, and cigarette tobacco in complying with the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and FDA regulations. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: 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, 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 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 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-D-2834 for ``Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule.'' Received comments will be placed in [[Page 37460]] the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of this guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Gerie Voss, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule.'' This guidance is intended to assist persons who manufacture, package, sell, offer to sell, distribute, or import for sale and distribution within the United States newly regulated tobacco products, RYO tobacco, and cigarette tobacco in complying with the FD&C Act, as amended by the Tobacco Control Act, and FDA regulations. We are issuing this guidance consistent with our good guidance practices (GGP) regulation (section 10.115 (21 CFR 10.115)). We are implementing this guidance without prior public comment, because we have determined that prior public participation is not feasible or appropriate (section 10.115(g)(2)). We made this determination because FDA needs to communicate the extensions in a timely manner given the upcoming compliance deadlines and the amount of time needed for firms to prepare for them. Although this guidance document is immediately effective, it remains subject to comment in accordance with FDA's GGP regulation. The Tobacco Control Act (Pub. L. 111-31) granted FDA the authority to immediately regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, RYO, and smokeless tobacco products to protect the public health and to reduce tobacco use by minors. The Tobacco Control Act also gave FDA the authority to issue a regulation deeming all other products that meet the statutory definition of a tobacco product to be subject to Chapter IX of the FD&C Act (section 901(b) (21 U.S.C. 387a(b)) of the FD&C Act). On May 10, 2016, FDA issued that rule, extending FDA's tobacco product authority to all products that meet the definition of tobacco product in the law (except for accessories of newly regulated tobacco products), including electronic nicotine delivery systems, cigars, hookah, pipe tobacco, nicotine gels, dissolvables that were not already subject to the FD&C Act, and other tobacco products that may be developed in the future (81 FR 28974 at 28976) (``the final deeming rule'')). Chapter IX of the FD&C Act now applies to newly regulated tobacco products, including sections 904(a)(1) and (4) (21 U.S.C.387d(a)(1) and (4)) (ingredient listing, health document submissions), 903(a)(4) and (a)(8) (21 U.S.C. 387c(a)(4) and (a)(8)) (labeling requirements), 904(c)(1), 905(b), (c), (d), (h) (registration), (21 U.S.C. 387e(b), (c), (d), (h)) 905(i)(1) (product listing), 907(a)(1)(B) (21 U.S.C. 387g(a)(1)(B)) (additional special rule), 911 (21 U.S.C. 387k) (modified risk claims), 904(a)(3) and 915 (21 U.S.C. 387o) (harmful and potentially harmful constituent reporting), and 920 (21 U.S.C. 387t) (labeling, recordkeeping, records inspection). The final rule also included several requirements that apply to a subgroup of products referred to as ``covered tobacco products.'' In May 2017, FDA published the first edition of this guidance document, under which it provided a 3-month extension of all future compliance deadlines for requirements under the final deeming rule. This guidance is the second edition, and it revises and updates the first edition by further extending certain of the future compliance dates. The guidance represents 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. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in section 910(c)(1)(A)(i) of the FD&C Act and 21 CFR part 1143 have been approved under OMB control number 0910-0768; the collections of information in section 905(j) of the FD&C Act have been approved under OMB control number 0910-0673; the collections of information in section 904(a)(4) of the FD&C Act have been approved under OMB control number 0910-0654; the collections of information in 21 CFR part 1107 have been approved under OMB control number 0910-0684; the collections of information in section 904(c)(1), 905(b),(c),(d), (h),and 905(i)(1) of the FD&C Act have been approved under OMB control number 0910-0650. [[Page 37461]] III. Electronic Access Persons with access to the internet may obtain an electronic version of the guidance at either https://www.regulations.gov or https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. Dated: August 4, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-16839 Filed 8-9-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 153 / Thursday, August 10, 2017 / Notices 37459
Staff, 5630 Fishers Lane, Rm. 1061, approximate time requested to make distribution within the United States
Rockville, MD 20852. their presentation on or before August newly regulated tobacco products, roll-
FOR FURTHER INFORMATION CONTACT: 16, 2017. Time allotted for each your-own (RYO) tobacco, and cigarette
Jennifer Shepherd, Center for Drug presentation may be limited. If the tobacco in complying with the Federal
Evaluation and Research, Food and number of registrants requesting to Food, Drug, and Cosmetic Act (the
Drug Administration, 10903 New speak is greater than can be reasonably FD&C Act), as amended by the Family
Hampshire Ave., Bldg. 31, Rm. 2417, accommodated during the scheduled Smoking Prevention and Tobacco
Silver Spring, MD 20993–0002, 301– open public hearing session, FDA may Control Act (Tobacco Control Act), and
796–9001, Fax: 301–847–8533, email: conduct a lottery to determine the FDA regulations.
MIDAC@fda.hhs.gov, or FDA Advisory speakers for the scheduled open public DATES: Submit either electronic or
Committee Information Line, 1–800– hearing session. The contact person will written comments on Agency guidances
741–8138 (301–443–0572 in the notify interested persons regarding their at any time.
Washington, DC area). A notice in the request to speak by August 17, 2017. ADDRESSES: You may submit comments
Federal Register about last minute Persons attending FDA’s advisory as follows:
modifications that impact a previously committee meetings are advised that the
announced advisory committee meeting Agency is not responsible for providing Electronic Submissions
cannot always be published quickly access to electrical outlets. Submit electronic comments in the
enough to provide timely notice. FDA welcomes the attendance of the following way:
Therefore, you should always check the public at its advisory committee • Federal eRulemaking Portal:
Agency’s Web site at https:// meetings and will make every effort to https://www.regulations.gov. Follow the
www.fda.gov/AdvisoryCommittees/ accommodate persons with disabilities. instructions for submitting comments.
default.htm and scroll down to the If you require special accommodations Comments submitted electronically,
appropriate advisory committee meeting due to a disability, please contact including attachments, to https://
link, or call the advisory committee Jennifer Shepherd at least 7 days in www.regulations.gov will be posted to
information line to learn about possible advance of the meeting. the docket unchanged. Because your
modifications before coming to the FDA is committed to the orderly comment will be made public, you are
meeting. conduct of its advisory committee solely responsible for ensuring that your
SUPPLEMENTARY INFORMATION:
meetings. Please visit our Web site at comment does not include any
Agenda: The committee will discuss https://www.fda.gov/ confidential information that you or a
the potential risk of gadolinium AdvisoryCommittees/ third party may not wish to be posted,
retention in the brain and other body AboutAdvisoryCommittees/ such as medical information, your or
organs in patients receiving gadolinium- ucm111462.htm for procedures on anyone else’s Social Security number, or
based contrast agents for magnetic public conduct during advisory confidential business information, such
resonance clinical imaging procedures. committee meetings. as a manufacturing process. Please note
FDA intends to make background Notice of this meeting is given under that if you include your name, contact
material available to the public no later the Federal Advisory Committee Act (5 information, or other information that
than 2 business days before the meeting. U.S.C. app. 2). identifies you in the body of your
If FDA is unable to post the background Dated: August 7, 2017. comments, that information will be
material on its Web site prior to the Leslie Kux, posted on https://www.regulations.gov.
meeting, the background material will Associate Commissioner for Policy. • If you want to submit a comment
be made publicly available at the [FR Doc. 2017–16891 Filed 8–9–17; 8:45 am] with confidential information that you
location of the advisory committee BILLING CODE 4164–01–P
do not wish to be made available to the
meeting, and the background material public, submit the comment as a
will be posted on FDA’s Web site after written/paper submission and in the
the meeting. Background material is DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
available at https://www.fda.gov/ HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
AdvisoryCommittees/Calendar/
Written/Paper Submissions
default.htm. Scroll down to the Food and Drug Administration
appropriate advisory committee meeting Submit written/paper submissions as
[Docket No. FDA–2017–D–2834] follows:
link.
Procedure: Interested persons may • Mail/Hand delivery/Courier (for
Extension of Certain Tobacco Product
present data, information, or views, written/paper submissions): Dockets
Compliance Deadlines Related to the
orally or in writing, on issues pending Management Staff (HFA–305), Food and
Final Deeming Rule; Guidance for
before the committee. All electronic and Drug Administration, 5630 Fishers
Industry; Availability
written submissions submitted to the Lane, Rm. 1061, Rockville, MD 20852.
docket (see the ADDRESSES section) on or AGENCY: Food and Drug Administration, • For written/paper comments
before August 24, 2017, will be HHS. submitted to the Dockets Management
provided to the committee. Oral ACTION: Notice of availability. Staff, FDA will post your comment, as
presentations from the public will be well as any attachments, except for
scheduled between approximately 1 SUMMARY: The Food and Drug information submitted, marked and
p.m. and 2 p.m. Those individuals Administration (FDA) is announcing the identified, as confidential, if submitted
mstockstill on DSK30JT082PROD with NOTICES
interested in making formal oral availability of a guidance for industry as detailed in ‘‘Instructions.’’
presentations should notify the contact entitled ‘‘Extension of Certain Tobacco Instructions: All submissions received
person and submit a brief statement of Product Compliance Deadlines Related must include the Docket No. FDA–
the general nature of the evidence or to the Final Deeming Rule.’’ This 2017–D–2834 for ‘‘Extension of Certain
arguments they wish to present, the guidance is intended to assist persons Tobacco Product Compliance Deadlines
names and addresses of proposed who manufacture, package, sell, offer to Related to the Final Deeming Rule.’’
participants, and an indication of the sell, distribute, or import for sale and Received comments will be placed in
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III. Electronic Access SUPPLEMENTARY INFORMATION: The DEPARTMENT OF HOMELAND
Persons with access to the internet United States is signatory to the SECURITY
may obtain an electronic version of the International Maritime Organization’s
guidance at either https:// International Regulations for Preventing Coast Guard
www.regulations.gov or https:// Collisions at Sea, 1972 (72 COLREGS), [Docket No. USCG–2017–0219]
www.fda.gov/TobaccoProducts/ as amended. The special construction or
Labeling/RulesRegulationsGuidance/ purpose of some vessels makes them Information Collection Request to
default.htm. unable to comply with the light, shape, Office of Management and Budget;
Dated: August 4, 2017. and sound signal provisions of the 72 OMB Control Number: 1625–0078
Anna K. Abram, COLREGS. Under statutory law 1 and AGENCY:Coast Guard, DHS.
Deputy Commissioner for Policy, Planning, Coast Guard regulation, 2 a vessel may
Sixty-day notice requesting
ACTION:
Legislation, and Analysis. instead meet alternative requirements
comments.
[FR Doc. 2017–16839 Filed 8–9–17; 8:45 am] and the vessel’s owner, builder,
BILLING CODE 4164–01–P operator, or agent may apply for a SUMMARY: In compliance with the
COAC. For vessels of special Paperwork Reduction Act of 1995, the
construction, the cognizant Coast Guard U.S. Coast Guard intends to submit an
DEPARTMENT OF HOMELAND District Office determines whether the Information Collection Request (ICR) to
SECURITY vessel for which the COAC is sought the Office of Management and Budget
complies as closely as possible with the (OMB), Office of Information and
Coast Guard 72 COLREGS and decides whether to Regulatory Affairs (OIRA), requesting a
[Docket No. USCG–2017–0648] issue the COAC. Once issued, a COAC Reinstatement, without change, of a
remains valid until information previously approved collection for
Certificate of Alternative Compliance supplied in the COAC application or the which approval has expired: 1625–0078,
for Viking Yacht Company’s 92C COAC terms become inapplicable to the Credentialing and Manning
Enclosed Bridge Yacht, HIN: vessel. Under the governing statute 3 Requirements for Officers on Towing
VKY92111I617 and regulation,4 the Coast Guard must Vessels; without change. Our ICR
publish notice of this action. describes the information we seek to
AGENCY: Coast Guard, DHS. collect from the public. Before
ACTION: Notice. The Commandant, U.S. Coast Guard, submitting this ICR to OIRA, the Coast
hereby finds and certifies that Viking Guard is inviting comments as
SUMMARY: The Coast Guard announces Yacht Company’s 92C Enclosed Bridge described below.
that the District Five Prevention yacht, HIN: VKY92111I617, is a vessel
Division (Dp) has issued a Certificate of DATES: Comments must reach the Coast
of special construction or purpose and Guard on or before October 10, 2017.
Alternate Compliance (COAC) from the
that, with respect to the position of the ADDRESSES: You may submit comments
International Regulations for Preventing
Collisions at Sea, 1972 (72 COLREGS), masthead light, it is not possible to identified by Coast Guard docket
for Viking Yacht Company’s 92C comply fully with the requirements of number [USCG–2017–0219] to the Coast
Enclosed Bridge yacht, HIN: the provisions enumerated in the 72 Guard using the Federal eRulemaking
VKY92111I617, as required by statue. COLREGS without interfering with the Portal at http://www.regulations.gov.
Due to the construction and placement design and construction of the vessel. See the ‘‘Public participation and
of the pilothouse aft of amidships, the The Prevention Division, Fifth Coast request for comments’’ portion of the
vessel cannot fully comply with the Guard District, further finds and SUPPLEMENTARY INFORMATION section for
masthead light provisions of the 72 certifies that the proposed placement of further instructions on submitting
COLREGS without interfering with the the masthead light is in the closest comments.
vessel’s design and construction, as possible compliance with the applicable A copy of the ICR is available through
there are no structures forward of provisions of the 72 COLREGS and that the docket on the Internet at http://
amidships on which a masthead light full compliance with the 72 COLREGS www.regulations.gov. Additionally,
could be affixed. This notice promotes would not significantly enhance the copies are available from:
the Coast Guard’s maritime safety and safety of the vessel’s operation. COMMANDANT (CG–612), ATTN:
stewardship missions. PAPERWORK REDUCTION ACT
This notice is issued under authority
ADDRESSES: Documents mentioned in MANAGER, U.S. COAST GUARD, 2703
of 33 U.S.C. 1605(c) and 33 CFR 81.
the preamble are part of docket USCG– MARTIN LUTHER KING JR AVE SE.,
2017–0648. To view documents Dated: July 31, 2017. STOP 7710, WASHINGTON, DC 20593–
mentioned in this preamble as being Jerry R. Barnes, 7710.
available in the docket, go to the Federal Captain, Chief, Prevention Division, U. S. FOR FURTHER INFORMATION: Contact Mr.
eRulemaking Portal at http:// Coast Guard. Anthony Smith, Office of Information
www.regulations.gov, type the docket [FR Doc. 2017–16844 Filed 8–9–17; 8:45 am] Management, telephone 202–475–3532,
number in the ‘‘SEARCH’’ box, and BILLING CODE 9110–04–P
or fax 202–372–8405, for questions on
click ‘‘SEARCH.’’ Click on ‘‘Open these documents.
Docket Folder’’ on the line associated SUPPLEMENTARY INFORMATION:
with this notice.
mstockstill on DSK30JT082PROD with NOTICES
FOR FURTHER INFORMATION CONTACT: For
Public Participation and Request for
further information or questions about Comments
this notice, call or email: CDR Scott W. This Notice relies on the authority of
Muller, District Five, Chief, Inspections 1 33 U.S.C. 1605(c). the Paperwork Reduction Act of 1995;
and Investigations, U.S. Coast Guard; 2 33 CFR 81.3. 44 U.S.C. Chapter 35, as amended. An
telephone: 757–398–6389, email: 3 33 U.S.C. 1605(c). ICR is an application to OIRA seeking
Scott.W.Muller@uscg.mil. 4 33 CFR 81.18. the approval, extension, or renewal of a
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Document Created: 2017-08-10 01:01:31
Document Modified: 2017-08-10 01:01:31
| 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 availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Gerie Voss, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, email: [email protected] | |
| FR Citation | 82 FR 37459 |
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