80 FR 55124 - Enforcement Policy for Certain (Provisional) Tobacco Products That the Food and Drug Administration Finds Not Substantially Equivalent; Guidance for Industry and Tobacco Retailers; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 177 (September 14, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 177 (September 14, 2015)
| Page Range | 55124-55125 | |
| FR Document | 2015-23001 |
[Federal Register Volume 80, Number 177 (Monday, September 14, 2015)] [Notices] [Pages 55124-55125] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-23001] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1600] Enforcement Policy for Certain (Provisional) Tobacco Products That the Food and Drug Administration Finds Not Substantially Equivalent; Guidance for Industry and Tobacco Retailers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent.'' This guidance provides information to tobacco retailers on FDA's enforcement policy regarding certain so- called provisional tobacco products that become subject to not substantially equivalent (NSE) orders issued under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-2000. 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. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Annette Marthaler, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-2000, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent.'' This guidance provides information to tobacco retailers on FDA's enforcement policy regarding certain so-called provisional tobacco products that become subject to NSE orders issued under the FD&C Act. We received several comments to the draft guidance (79 FR 10534, February 25, 2014), and those comments were considered as the guidance was finalized. II. Significance of Guidance This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent.'' It does not [[Page 55125]] 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. III. Comments A. General Information About Submitting Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. B. Public Availability of Comments Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. As a matter of Agency practice, FDA generally does not post comments submitted by individuals in their individual capacity on http://www.regulations.gov. This is determined by information indicating that the submission is written by an individual, for example, the comment is identified with the category ``Individual Consumer'' under the field titled ``Category (Required),'' on the ``Your Information'' page on www.regulations.gov. For this docket, however, FDA will not be following this general practice. Instead, FDA will post on http://www.regulations.gov comments to this docket that have been submitted by individuals in their individual capacity. If you wish to submit any information under a claim of confidentiality, please refer to 21 CFR 10.20. C. Information Identifying the Person Submitting the Comment Please note that your name, contact information, and other information identifying you will be posted on http://www.regulations.gov if you include that information in the body of your comments. For electronic comments submitted to http://www.regulations.gov, FDA will post the body of your comment on http://www.regulations.gov along with your State/province and country (if provided), the name of your representative (if any), and the category identifying you (e.g., individual, consumer, academic, industry). For written submissions submitted to the Division of Dockets Management, FDA will post the body of your comments on http://www.regulations.gov, but you can put your name and/or contact information on a separate cover sheet and not in the body of your comments. IV. Electronic Access Persons with access to the Internet may obtain an electronic version of the guidance at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm. Dated: September 9, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-23001 Filed 9-11-15; 8:45 am] BILLING CODE 4164-01-P
![55124 Federal Register / Vol. 80, No. 177 / Monday, September 14, 2015 / Notices
AboutAdvisoryCommittees/ 15, 2015. Time allotted for each certain so-called provisional tobacco
ucm408555.htm. presentation may be limited. If the products that become subject to not
Contact Person: Stephanie L. number of registrants requesting to substantially equivalent (NSE) orders
Begansky, Center for Drug Evaluation speak is greater than can be reasonably issued under the Federal Food, Drug,
and Research, Food and Drug accommodated during the scheduled and Cosmetic Act (the FD&C Act).
Administration, 10903 New Hampshire open public hearing session, FDA may DATES: Submit either electronic or
Ave., Bldg. 31, Rm. 2417, Silver Spring, conduct a lottery to determine the written comments on Agency guidances
MD 20993–0002, 301–796–9001, FAX: speakers for the scheduled open public at any time.
301–847–8533, AADPAC@fda.hhs.gov, hearing session. The contact person will ADDRESSES: Submit written requests for
or FDA Advisory Committee notify interested persons regarding their single copies of this guidance to the
Information Line, 1–800–741–8138 request to speak by October 16, 2015. Center for Tobacco Products, Food and
(301–443–0572 in the Washington, DC Persons attending FDA’s advisory Drug Administration, Document Control
area). A notice in the Federal Register committee meetings are advised that the Center, 10903 New Hampshire Ave.,
about last minute modifications that Agency is not responsible for providing Bldg. 71, Rm. G335, Silver Spring, MD
impact a previously announced access to electrical outlets. 20993–2000. Send one self-addressed
advisory committee meeting cannot FDA welcomes the attendance of the
adhesive label to assist that office in
always be published quickly enough to public at its advisory committee
processing your request or include a fax
provide timely notice. Therefore, you meetings and will make every effort to
number to which the guidance
should always check the Agency’s Web accommodate persons with disabilities.
document may be sent. See the
site at http://www.fda.gov/ If you require accommodations due to a
SUPPLEMENTARY INFORMATION section for
AdvisoryCommittees/default.htm and disability, please contact Stephanie L.
information on electronic access to the
scroll down to the appropriate advisory Begansky at least 7 days in advance of
guidance.
committee meeting link, or call the the meeting. Submit electronic comments on the
advisory committee information line to FDA is committed to the orderly
guidance to http://www.regulations.gov.
learn about possible modifications conduct of its advisory committee
Submit written comments to the
before coming to the meeting. meetings. Please visit our Web site at
Agenda: The committee will discuss Division of Dockets Management (HFA–
http://www.fda.gov/
new drug application (NDA) 022225, 305), Food and Drug Administration,
AdvisoryCommittees/
sugammadex sodium injection, 5630 Fishers Lane, Rm. 1061, Rockville,
AboutAdvisoryCommittees/
submitted by Organon USA Inc., a MD 20852. Identify comments with the
ucm111462.htm for procedures on
subsidiary of Merck & Co., Inc., for the docket number found in brackets in the
public conduct during advisory
proposed indication of reversal of heading of this document.
committee meetings.
moderate or deep neuromuscular Notice of this meeting is given under FOR FURTHER INFORMATION CONTACT:
blockade (NMB) induced by rocuronium the Federal Advisory Committee Act (5 Annette Marthaler, Center for Tobacco
or vecuronium. U.S.C. app. 2). Products, Food and Drug
FDA intends to make background Administration, Document Control
Dated: September 8, 2015. Center, 10903 New Hampshire Ave.,
material available to the public no later
Jill Hartzler Warner, Bldg. 71, Rm. G335, Silver Spring, MD
than 2 business days before the meeting.
If FDA is unable to post the background Associate Commissioner for Special Medical 20993–2000, email: CTPRegulations@
Programs. fda.hhs.gov.
material on its Web site prior to the
meeting, the background material will [FR Doc. 2015–22984 Filed 9–11–15; 8:45 am]
SUPPLEMENTARY INFORMATION:
be made publicly available at the BILLING CODE 4164–01–P
location of the advisory committee I. Background
meeting, and the background material FDA is announcing the availability of
will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND
a guidance for industry entitled
the meeting. Background material is HUMAN SERVICES
‘‘Enforcement Policy for Certain
available at http://www.fda.gov/ Food and Drug Administration (Provisional) Tobacco Products that
AdvisoryCommittees/Calendar/ FDA Finds Not Substantially
default.htm. Scroll down to the [Docket No. FDA–2013–D–1600] Equivalent.’’ This guidance provides
appropriate advisory committee meeting information to tobacco retailers on
link. Enforcement Policy for Certain
FDA’s enforcement policy regarding
Procedure: Interested persons may (Provisional) Tobacco Products That
certain so-called provisional tobacco
present data, information, or views, the Food and Drug Administration
products that become subject to NSE
orally or in writing, on issues pending Finds Not Substantially Equivalent;
orders issued under the FD&C Act. We
before the committee. Written Guidance for Industry and Tobacco
received several comments to the draft
submissions may be made to the contact Retailers; Availability
guidance (79 FR 10534, February 25,
person on or before October 23, 2015. AGENCY: Food and Drug Administration, 2014), and those comments were
Oral presentations from the public will HHS. considered as the guidance was
be scheduled between approximately 1 ACTION: Notice. finalized.
p.m. and 2 p.m. Those individuals
interested in making formal oral SUMMARY: The Food and Drug II. Significance of Guidance
presentations should notify the contact Administration (FDA) is announcing the This guidance is being issued
tkelley on DSK3SPTVN1PROD with NOTICES
person and submit a brief statement of availability of a guidance for industry consistent with FDA’s good guidance
the general nature of the evidence or entitled ‘‘Enforcement Policy for Certain practices regulation (21 CFR 10.115).
arguments they wish to present, the (Provisional) Tobacco Products that The guidance represents the current
names and addresses of proposed FDA Finds Not Substantially thinking of FDA on ‘‘Enforcement
participants, and an indication of the Equivalent.’’ This guidance provides Policy for Certain (Provisional) Tobacco
approximate time requested to make information to tobacco retailers on Products that FDA Finds Not
their presentation on or before October FDA’s enforcement policy regarding Substantially Equivalent.’’ It does not
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![Federal Register / Vol. 80, No. 177 / Monday, September 14, 2015 / Notices 55125
establish any rights for any person and http://www.regulations.gov, but you can DATES: The Authorization is effective as
is not binding on FDA or the public. put your name and/or contact of July 31, 2015.
You can use an alternative approach if information on a separate cover sheet ADDRESSES: Submit written requests for
it satisfies the requirements of the and not in the body of your comments. single copies of the EUA to the Office
applicable statutes and regulations. of Counterterrorism and Emerging
IV. Electronic Access
III. Comments Threats, Food and Drug Administration,
Persons with access to the Internet 10903 New Hampshire Ave., Bldg. 1,
A. General Information About may obtain an electronic version of the Rm. 4338, Silver Spring, MD 20993–
Submitting Comments guidance at either http:// 0002. Send one self-addressed adhesive
www.regulations.gov or http:// label to assist that office in processing
Interested persons may submit either
www.fda.gov/TobaccoProducts/ your request or include a fax number to
electronic comments regarding this
GuidanceComplianceRegulatory which the Authorization may be sent.
document to http://www.regulations.gov
Information/default.htm. See the SUPPLEMENTARY INFORMATION
or written comments to the Division of
Dockets Management (see ADDRESSES). It Dated: September 9, 2015. section for electronic access to the
is only necessary to send one set of Leslie Kux, Authorization.
comments. Identify comments with the Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT:
docket number found in brackets in the [FR Doc. 2015–23001 Filed 9–11–15; 8:45 am] Carmen Maher, Acting Assistant
heading of this document. BILLING CODE 4164–01–P
Commissioner for Counterterrorism
Policy and Acting Director, Office of
B. Public Availability of Comments Counterterrorism and Emerging Threats,
Received comments may be seen in DEPARTMENT OF HEALTH AND Food and Drug Administration, 10903
the Division of Dockets Management HUMAN SERVICES New Hampshire Ave., Bldg. 1, Rm.
between 9 a.m. and 4 p.m., Monday 4347, Silver Spring, MD 20993–0002,
through Friday, and will be posted to Food and Drug Administration 301–796–8510 (this is not a toll free
the docket at http:// number).
[Docket No. FDA–2014–N–1206]
www.regulations.gov. As a matter of SUPPLEMENTARY INFORMATION:
Agency practice, FDA generally does Authorization of Emergency Use of an
not post comments submitted by I. Background
In Vitro Diagnostic Device for
individuals in their individual capacity Detection of Ebola Zaire Virus; Section 564 of the FD&C Act (21
on http://www.regulations.gov. This is Availability U.S.C. 360bbb–3) as amended by the
determined by information indicating Project BioShield Act of 2004 (Pub. L.
that the submission is written by an AGENCY: Food and Drug Administration, 108–276) and the Pandemic and All-
individual, for example, the comment is HHS. Hazards Preparedness Reauthorization
identified with the category ‘‘Individual ACTION: Notice. Act of 2013 (Pub. L. 113–5) allows FDA
Consumer’’ under the field titled to strengthen the public health
‘‘Category (Required),’’ on the ‘‘Your SUMMARY: The Food and Drug protections against biological, chemical,
Information’’ page on Administration (FDA) is announcing the nuclear, and radiological agents. Among
www.regulations.gov. For this docket, issuance of an Emergency Use other things, section 564 of the FD&C
however, FDA will not be following this Authorization (EUA) (the Authorization) Act allows FDA to authorize the use of
general practice. Instead, FDA will post for an in vitro diagnostic device for an unapproved medical product or an
on http://www.regulations.gov detection of the Ebola Zaire virus in unapproved use of an approved medical
comments to this docket that have been response to the Ebola virus outbreak in product in certain situations. With this
submitted by individuals in their West Africa. FDA issued this EUA authority, FDA can help assure
individual capacity. If you wish to Authorization under the Federal Food, that medical countermeasures may be
submit any information under a claim of Drug, and Cosmetic Act (the FD&C Act), used in emergencies to diagnose, treat,
confidentiality, please refer to 21 CFR as requested by OraSure Technologies, or prevent serious or life-threatening
10.20. Inc. The Authorization contains, among diseases or conditions caused by
other things, conditions on the biological, chemical, nuclear, or
C. Information Identifying the Person emergency use of the authorized in vitro radiological agents when there are no
Submitting the Comment diagnostic device. The Authorization adequate, approved, and available
Please note that your name, contact follows the September 22, 2006, alternatives.
information, and other information determination by then-Secretary of the Section 564(b)(1) of the FD&C Act
identifying you will be posted on Department of Homeland Security provides that, before an EUA may be
http://www.regulations.gov if you (DHS), Michael Chertoff, that the Ebola issued, the Secretary of HHS must
include that information in the body of virus presents a material threat against declare that circumstances exist
your comments. For electronic the U.S. population sufficient to affect justifying the authorization based on
comments submitted to http:// national security. On the basis of such one of the following grounds: (1) A
www.regulations.gov, FDA will post the determination, the Secretary of Health determination by the Secretary of
body of your comment on http:// and Human Services (HHS) declared on Homeland Security that there is a
www.regulations.gov along with your August 5, 2014, that circumstances exist domestic emergency, or a significant
State/province and country (if justifying the authorization of potential for a domestic emergency,
tkelley on DSK3SPTVN1PROD with NOTICES
provided), the name of your emergency use of in vitro diagnostic involving a heightened risk of attack
representative (if any), and the category devices for detection of Ebola virus with a biological, chemical, radiological,
identifying you (e.g., individual, subject to the terms of any authorization or nuclear agent or agents; (2) a
consumer, academic, industry). For issued under the FD&C Act. The determination by the Secretary of
written submissions submitted to the Authorization, which includes an Defense that there is a military
Division of Dockets Management, FDA explanation of the reasons for issuance, emergency, or a significant potential for
will post the body of your comments on is reprinted in this document. a military emergency, involving a
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Document Created: 2018-02-26 10:15:14
Document Modified: 2018-02-26 10:15:14
| 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 electronic or written comments on Agency guidances at any time. | |
| Contact | Annette Marthaler, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-2000, email: [email protected] | |
| FR Citation | 80 FR 55124 |
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