Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Guidance for Industry; Availability, 46087-46088 [2016-16734]
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Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Notices
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: July 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–16739 Filed 7–14–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0508]
Registration and Product Listing for
Owners and Operators of Domestic
Tobacco Product Establishments;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a revised guidance for
industry entitled ‘‘Registration and
Product Listing for Owners and
Operators of Domestic Tobacco Product
Establishments.’’ This guidance is
intended to assist persons making
tobacco product establishment
registration and product listing
submissions to FDA.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, 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.
VerDate Sep<11>2014
19:03 Jul 14, 2016
Jkt 238001
• 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–
2009–D–0508 for ‘‘Registration and
Product Listing for Owners and
Operators of Domestic Tobacco Product
Establishments.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
46087
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://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 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 Division of Dockets
Management, 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, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, 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:
Katherine Collins, Center for Tobacco
Products, Food and Drug
Administration, Document Control
Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
20993–0002, email: CTPRegulations@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a revised guidance for industry entitled,
‘‘Registration and Product Listing for
Owners and Operators of Domestic
Tobacco Product Establishments.’’ This
guidance is intended to assist persons
making tobacco product establishment
registration and product listing
submissions to FDA. We are issuing this
guidance consistent with our good
guidance practices (GGP) regulation
(§ 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 given the requirement that
registration and listing submissions be
submitted by December 31, 2016
(§ 10.115(g)(2)). We made this
determination because the guidance
presents a less burdensome policy
consistent with the public health.
Although this guidance document is
immediately in effect, it remains subject
to comment in accordance with FDA’’s
GGP regulation.
E:\FR\FM\15JYN1.SGM
15JYN1
46088
Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Notices
The Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act) (Pub. L. 111–31) added section 905
to the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 387e),
establishing requirements for tobacco
product establishment registration and
product listing.
FDA revised the registration and
listing guidance to include newly
deemed tobacco products. Cigarettes,
cigarette tobacco, roll-your-own tobacco,
and smokeless tobacco were
immediately covered by FDA’s tobacco
product authorities in chapter IX of the
FD&C Act, including section 905, when
the Tobacco Control Act went into
effect. As for other types of tobacco
products, section 901(b) of the FD&C
Act (21 U.S.C. 387a) grants FDA
authority to deem those products
subject to chapter IX of the FD&C Act.
Pursuant to that authority, FDA issued
a proposed rule seeking to deem all
other products that meet the statutory
definition of tobacco product, set forth
in section 201(rr) of the FD&C Act (21
U.S.C. 321(rr)) (except for accessories of
those products) (79 FR 23142). After
review and consideration of comments
on the proposed rule, FDA published
the final rule on May 10, 2016 (81 FR
28974) (‘‘the deeming rule’’) and it will
become effective on August 8, 2016. As
a result, owners and operators of
domestic establishments engaged in the
manufacture, preparation,
compounding, or processing of tobacco
products subject to the deeming rule are
now required to comply with chapter IX
of the FD&C Act, including the
establishment registration and product
listing requirements in section 905.
sradovich on DSK3GMQ082PROD with NOTICES
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (§ 10.115). The
guidance represents the current thinking
of FDA on registration and product
listing for owners and operators of
domestic tobacco product
establishments. 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.
III. Paperwork Reduction Act of 1995
This guidance contains information
collection provisions that 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 time required to complete
this information collection is estimated
to average 3.75 hours per response,
including the time to review
VerDate Sep<11>2014
19:03 Jul 14, 2016
Jkt 238001
instructions, search existing data
sources, gather the data needed, and
complete and review the information
collection. Send comments regarding
this burden estimate or suggestions for
reducing this burden to: Food and Drug
Administration, Center for Tobacco
Products, Document Control Center,
10903 New Hampshire Ave., Bldg. 71,
Rm. G335, Silver Spring, MD 20993–
0002.
An Agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. The OMB control
number for this information collection
is 0910–0650 (expires June 30, 2019).
IV. 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: July 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–16734 Filed 7–14–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Council on Graduate Medical
Education; Request for Nominations
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration (HRSA) is
requesting nominations to fill vacancies
on the Council on Graduate Medical
Education (COGME). COGME is
authorized by Section 762 of the Public
Health Service (PHS) Act (42 U.S.C.
294o), as amended. The Advisory
Council is governed by the provisions of
the Federal Advisory Act (FACA) (5
U.S.C. Appendix 2), as amended, which
sets forth standards for the formation
and use of advisory committees, and
applies to the extent that the provisions
of FACA do not conflict with the
requirements of PHS Act Section 762.
DATES: The agency will receive
nominations on a continuous basis.
ADDRESSES: All nominations should be
submitted to Advisory Council
Operations, Bureau of Health
Workforce, HRSA, 11W45C, 5600
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Fishers Lane, Rockville, Maryland
20857. Mail delivery should be
addressed to Advisory Council
Operations, Bureau of Health
Workforce, HRSA, at the above address,
or via email to: BHWAdvisoryCouncil
FRN@hrsa.gov.
Joan
Weiss, Ph.D., RN, CRNP, FAAN,
Designated Federal Official, COGME at
301–443–0430 or email at jweiss@
hrsa.gov. A copy of the current
committee membership, charter, and
reports can be obtained by accessing the
Web site https://www.hrsa.gov/
advisorycommittees/bhpradvisory/
COGME/.
FOR FURTHER INFORMATION CONTACT:
COGME
provides advice and makes policy
recommendations to the Secretary of the
U.S. Department of Health and Human
Services (Secretary) and ranking
members of the Senate Committee on
Health, Education, Labor and Pensions,
and the U.S. House of Representatives
Committee on Energy and Commerce on
matters concerning the supply and
distribution of physicians in the United
States, physician workforce trends,
training issues, and financing policies.
Meetings are held twice a year.
Specifically, HRSA is requesting
nominations for voting members of
COGME representing: Practicing
primary care physicians, national and
specialty physician organizations,
foreign medical graduates, medical
student and house staff associations, as
well as representatives of schools of
medicine, schools of osteopathic
medicine, public and private teaching
hospitals, health insurers, business, and
labor. Among these nominations,
medical students, residents, and/or
fellows from these programs are
encouraged to apply.
The Department of Health and Human
Services (HHS) will consider
nominations of all qualified individuals
with the areas of subject matter
expertise noted above. Individuals may
nominate themselves or other
individuals, and professional
associations and organizations may
nominate one or more qualified persons
for membership. Nominations shall state
that the nominee is willing to serve as
a member of COGME and appears to
have no conflict of interest that would
preclude COGME membership.
Potential candidates will be asked to
provide detailed information concerning
financial interests, consultancies,
research grants, and/or contracts that
might be affected by recommendations
of COGME to permit evaluation of
possible sources of conflicts of interest.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\15JYN1.SGM
15JYN1
Agencies
[Federal Register Volume 81, Number 136 (Friday, July 15, 2016)]
[Notices]
[Pages 46087-46088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16734]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0508]
Registration and Product Listing for Owners and Operators of
Domestic Tobacco Product Establishments; 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 revised guidance for industry entitled ``Registration
and Product Listing for Owners and Operators of Domestic Tobacco
Product Establishments.'' This guidance is intended to assist persons
making tobacco product establishment registration and product listing
submissions to FDA.
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): 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-2009-D-0508 for ``Registration and Product Listing for Owners and
Operators of Domestic Tobacco Product Establishments.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' 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.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 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 Division of Dockets Management, 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, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, 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: Katherine Collins, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
email: CTPRegulations@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised guidance for
industry entitled, ``Registration and Product Listing for Owners and
Operators of Domestic Tobacco Product Establishments.'' This guidance
is intended to assist persons making tobacco product establishment
registration and product listing submissions to FDA. We are issuing
this guidance consistent with our good guidance practices (GGP)
regulation (Sec. 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 given the
requirement that registration and listing submissions be submitted by
December 31, 2016 (Sec. 10.115(g)(2)). We made this determination
because the guidance presents a less burdensome policy consistent with
the public health. Although this guidance document is immediately in
effect, it remains subject to comment in accordance with FDA''s GGP
regulation.
[[Page 46088]]
The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111-31) added section 905 to the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387e), establishing
requirements for tobacco product establishment registration and product
listing.
FDA revised the registration and listing guidance to include newly
deemed tobacco products. Cigarettes, cigarette tobacco, roll-your-own
tobacco, and smokeless tobacco were immediately covered by FDA's
tobacco product authorities in chapter IX of the FD&C Act, including
section 905, when the Tobacco Control Act went into effect. As for
other types of tobacco products, section 901(b) of the FD&C Act (21
U.S.C. 387a) grants FDA authority to deem those products subject to
chapter IX of the FD&C Act. Pursuant to that authority, FDA issued a
proposed rule seeking to deem all other products that meet the
statutory definition of tobacco product, set forth in section 201(rr)
of the FD&C Act (21 U.S.C. 321(rr)) (except for accessories of those
products) (79 FR 23142). After review and consideration of comments on
the proposed rule, FDA published the final rule on May 10, 2016 (81 FR
28974) (``the deeming rule'') and it will become effective on August 8,
2016. As a result, owners and operators of domestic establishments
engaged in the manufacture, preparation, compounding, or processing of
tobacco products subject to the deeming rule are now required to comply
with chapter IX of the FD&C Act, including the establishment
registration and product listing requirements in section 905.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec. 10.115). The guidance represents the
current thinking of FDA on registration and product listing for owners
and operators of domestic tobacco product establishments. 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.
III. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that 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 time
required to complete this information collection is estimated to
average 3.75 hours per response, including the time to review
instructions, search existing data sources, gather the data needed, and
complete and review the information collection. Send comments regarding
this burden estimate or suggestions for reducing this burden to: Food
and Drug Administration, Center for Tobacco Products, Document Control
Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD
20993-0002.
An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control number for this
information collection is 0910-0650 (expires June 30, 2019).
IV. 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: July 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16734 Filed 7-14-16; 8:45 am]
BILLING CODE 4164-01-P