Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act, 70232-70235 [2015-28787]
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Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices
the performance of its child support
enforcement program in accordance
with standards specified by the
Secretary of the Department of Health
and Human Services, and to provide a
report of the findings to the Secretary.
This information is required to
determine if States are complying with
Federal child support mandates and
providing the best services possible. The
report is also intended to be used as a
management tool to help States evaluate
their programs and assess performance.
Respondents: State Child Support
Enforcement Agencies or the
Department/Agency/Bureau responsible
for Child Support Enforcement in each
State.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Self-assessment report ....................................................................................
54
1
4
216
........................
........................
........................
216
Estimated Total Annual Burden Hours: ....................................................
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–28820 Filed 11–12–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jstallworth on DSK7TPTVN1PROD with NOTICES
[Docket No. FDA–2011–N–0920]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based
Preventive Controls for Human Food
AGENCY:
ACTION:
Notice.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based
Preventive Controls for Human Food’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On
September 17, 2015, the Agency
submitted a proposed collection of
information entitled ‘‘Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Human Food’’ to OMB for
review and clearance under 44 U.S.C.
3507. 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. OMB has now
approved the information collection and
has assigned OMB control number
0910–0751. The approval expires on
October 31, 2018. A copy of the
supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: November 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–28790 Filed 11–12–15; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration,
HHS.
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Food and Drug Administration
[Docket No. FDA–2012–D–0049]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Reporting Harmful
and Potentially Harmful Constituents
in Tobacco Products and Tobacco
Smoke Under the Federal Food, Drug,
and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the collection of information associated
with the reporting of harmful and
potentially harmful constituents in
tobacco products and tobacco smoke
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
DATES: Submit either electronic or
written comments on the collection of
information by January 12, 2016.
ADDRESSES: You may submit comments
as follows:
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,
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Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices
jstallworth on DSK7TPTVN1PROD with NOTICES
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–
2012–D–0049 for the information
collection request entitled ‘‘Reporting
Harmful and Potentially Harmful
Constituents in Tobacco Products and
Tobacco Smoke Under the Federal
Food, Drug, and Cosmetic Act.’’
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
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Jkt 238001
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.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
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comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Reporting Harmful and Potentially
Harmful Constituents in Tobacco
Products and Tobacco Smoke Under
the Federal Food, Drug, and Cosmetic
Act (OMB Control Number 0910–
0732)—Extension
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Pub. L. 111–
31) into law. This law amended the
FD&C Act and granted FDA authority to
regulate the manufacture, marketing,
and distribution of tobacco products to
protect public health generally and to
reduce tobacco use by minors. Section
904(a)(3) of the FD&C Act (21 U.S.C.
387d(a)(3)) required each tobacco
product manufacturer or importer, or an
agent, to begin reporting to FDA no later
than June 22, 2012, ‘‘all constituents,
including smoke constituents, identified
by [FDA] as harmful or potentially
harmful to health in each tobacco
product, and as applicable in the smoke
of each tobacco product.’’ Reports must
be by the brand and by quantity in each
brand and subbrand. Section 904(c)(1)
of the FD&C Act states that
manufacturers of tobacco products not
on the market as of June 22, 2009, must
also provide information reportable
under section 904(a)(3) at least 90 days
prior to introducing the product into
interstate commerce.
FDA has taken several steps to
identify harmful and potentially
harmful constituents (HPHCs) to be
reported under sections 904(a)(3) and
(c)(1) of the FD&C Act, including issuing
a guidance discussing FDA’s current
thinking on the meaning of the term
‘‘harmful and potentially harmful
constituent’’ in the context of
implementing the HPHC list
requirement under section 904(e) of the
FD&C Act (76 FR 5387, January 31,
2011). The guidance is available on the
Internet at https://www.fda.gov/Tobacco
Products/GuidanceCompliance
RegulatoryInformation/ucm241339.htm.
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In addition, in the Federal Register of
April 3, 2012 (77 FR 20034), FDA
published a notice (the HPHC list
notice) announcing the established list
of HPHCs as required by section 904(e)
of the FD&C Act and describing the
criteria we used in identifying the
HPHCs for the established list.
Previously, FDA sought comment on
both the criteria that would be used to
identify HPHCs for the established list
and a list of chemicals and chemical
compounds that met the proposed
criteria.
The purpose of the information
collection is to collect statutorily
mandated information regarding HPHCs
provides instructions for completing
and submitting HPHC information to
FDA. The forms contain fields for
company information, product
information, and HPHC information.
Respondents finished reporting initial
HPHC information under section
904(a)(3) in 2012, and this collection of
information is in connection with the
reporting requirements under section
904(c)(1) of the FD&C Act for tobacco
products introduced into interstate
commerce after June 22, 2009.
FDA estimates the burden of this
collection of information as follows:
in tobacco products and tobacco smoke,
by quantity in each brand and subbrand.
To facilitate the submission of HPHC
information, FDA has developed Forms
3787a, 3787b, and 3787c in both paper
and electronic formats. Manufacturers
or importers, or their agents, may
submit information either electronically
or in paper format. The FDA eSubmitter
tool provides electronic forms to
streamline the data entry and
submission process for reporting
HPHCs. Users of eSubmitter may
populate an FDA-created Excel file and
import data into eSubmitter. Whether
respondents decide to submit reports
electronically or on paper, each form
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Information collected
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Reporting for Section 904(c)(1) Products
1. Reporting of Manufacturer Company and Product Information by Completing Submission Forms
Cigarette .......................................................................
78
0.79
Roll-Your-Own ..............................................................
39
0.21
Smokeless ....................................................................
52
0.21
Total .......................................................................
........................
........................
62
8
11
1.82
0.43
0.63
113
3
7
........................
........................
123
2. Testing of HPHC Quantities in Products
Cigarette Filler ..............................................................
Roll-Your-Own ..............................................................
Smokeless ....................................................................
78
39
52
0.79
0.21
0.21
62
8
11
9.42
9.42
12.06
584
75
133
Total .......................................................................
........................
........................
........................
........................
792
3. Testing of HPHC Quantities in Mainstream Smoke
Cigarette: International Organization for Standardization (ISO) Regimen ...................................................
Cigarette: Health Canada Regimen .............................
78
78
0.79
0.79
62
62
23.64
23.64
1,466
1,466
Total .......................................................................
Total Section 904(c)(1) Reporting Burden Hours
........................
........................
........................
........................
........................
........................
........................
........................
2,932
3,847
jstallworth on DSK7TPTVN1PROD with NOTICES
1 There
are no capital costs or operating costs associated with this collection of information.
Table 1 contains estimates for new
product information received annually
under section 904(c)(1) of the FD&C Act.
Manufacturers must report HPHC
information under section 904(c)(1) of
the FD&C Act at least 90 days prior to
delivery for introduction into interstate
commerce. The total annual burden for
this collection of information is
estimated to be 3,847 hours. The burden
estimate for this collection of
information includes the time it will
take to test the products and prepare the
HPHC report.
Table 1 indicates that 169
respondents will submit HPHC reports
when new products enter the market.
Section 1 of the table addresses the time
required for manufacturers to report
their company information. We estimate
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that the time to report HPHC
information is no more than 1.82 hours
for cigarettes, 0.42 hours for roll-yourown, and 0.63 hours for smokeless
tobacco products for each response
regardless of whether the paper or
electronic form (Form FDA 3787) is
used. (The estimated times to report
smokeless tobacco products (0.63 hour)
and roll-your-own tobacco products
(0.43 hour) are lower than the estimated
reporting time for cigarette products
because fewer HPHCs are normally
reported for these two types of products.
The total annual burden for reporting
company and product information is
123 hours.
Section 2 of the table addresses the
time required for manufacturers to test
quantities of HPHCs in their products.
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The burden hour estimates include the
time needed to test the tobacco
products, draft testing reports, and draft
the report for FDA. For cigarette filler,
smokeless, and roll-your-own products,
we estimate the burden to be 792 annual
burden hours. The burden for each
product type reflects our estimate of the
time to test the tobacco products (i.e.,
carry out laboratory work).
In addition to addressing the time
required to report information and test
quantities of HPHCs in tobacco
products, section 3 of table 1 addresses
the time required for manufacturers to
test quantities of HPHCs in cigarette
smoke. The burden estimates include
testing the tobacco products, drafting
testing reports, and drafting the report
for FDA. We estimate the annualized
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Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices
burden for this section to be 2,932
hours. The annual burden reflects our
estimate to test the tobacco products
(i.e., carry out laboratory work). The
burden estimate assumes that
manufacturers report HPHC quantities
in cigarette mainstream smoke
according to the two smoking regimens
described in the table.
The estimated total annual burden for
the reporting of HPHC under section
904(c)(1) of the FD&C Act is 3,847
hours. We do not believe there are any
capital costs associated with this
collection.
Dated: November 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–28787 Filed 11–12–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1630]
Guidance on Qualification of
Biomarker—Galactomannan in Studies
of Treatments of Invasive
Aspergillosis; 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 guidance for industry
entitled ‘‘Guidance on Qualification of
Biomarker—Galactomannan in Studies
of Treatments of Invasive
Aspergillosis.’’ This guidance provides a
qualified context of use (COU) for
Galactomannan detection in serum and/
or bronchoalveolar lavage (BAL) fluid as
the sole microbiological criterion to
classify patients as having probable
invasive Aspergillosis (IA) for
enrollment in clinical trials. This
guidance also describes the
experimental conditions and constraints
for which this biomarker is qualified
through the CDER Biomarker
Qualification Program. This biomarker
can be used by drug developers for the
qualified COU in submissions of
investigational new drug applications
(INDs), new drug applications (NDAs),
and biologics license applications
(BLAs) without the relevant CDER
review group reconsidering and
reconfirming the suitability of the
biomarker.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
jstallworth on DSK7TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
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Jkt 238001
10.115(g)(5)), to ensure that the Agency
considers your comment on this
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the guidance by January 12, 2016
ADDRESSES: You may submit comment
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–
2013–D–1630 for ‘‘Guidance on
Qualification of Biomarker—
Galactomannan in Studies of
Treatments of Invasive Aspergillosis.’’
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
PO 00000
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70235
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.
FOR FURTHER INFORMATION CONTACT:
Marianne Noone, Center for Drug
Evaluation and Research (Office of
Translational Sciences, Immediate
Office), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 21,
Rm. 4528, Silver Spring, MD 20993–
0002, 301–796–2600.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Guidance on Qualification of
Biomarker—Galactomannan in Studies
of Treatments of Invasive
Aspergillosis.’’ In the Federal Register
of October 27, 2014 (79 FR 63921), FDA
E:\FR\FM\13NON1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)]
[Notices]
[Pages 70232-70235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28787]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0049]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Reporting Harmful and Potentially Harmful Constituents
in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and
Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
associated with the reporting of harmful and potentially harmful
constituents in tobacco products and tobacco smoke under the Federal
Food, Drug, and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or written comments on the collection
of information by January 12, 2016.
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,
[[Page 70233]]
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-2012-D-0049 for the information collection request entitled
``Reporting Harmful and Potentially Harmful Constituents in Tobacco
Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic
Act.'' 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.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Reporting Harmful and Potentially Harmful Constituents in Tobacco
Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic
Act (OMB Control Number 0910-0732)--Extension
On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Pub. L. 111-31) into law. This law
amended the FD&C Act and granted FDA authority to regulate the
manufacture, marketing, and distribution of tobacco products to protect
public health generally and to reduce tobacco use by minors. Section
904(a)(3) of the FD&C Act (21 U.S.C. 387d(a)(3)) required each tobacco
product manufacturer or importer, or an agent, to begin reporting to
FDA no later than June 22, 2012, ``all constituents, including smoke
constituents, identified by [FDA] as harmful or potentially harmful to
health in each tobacco product, and as applicable in the smoke of each
tobacco product.'' Reports must be by the brand and by quantity in each
brand and subbrand. Section 904(c)(1) of the FD&C Act states that
manufacturers of tobacco products not on the market as of June 22,
2009, must also provide information reportable under section 904(a)(3)
at least 90 days prior to introducing the product into interstate
commerce.
FDA has taken several steps to identify harmful and potentially
harmful constituents (HPHCs) to be reported under sections 904(a)(3)
and (c)(1) of the FD&C Act, including issuing a guidance discussing
FDA's current thinking on the meaning of the term ``harmful and
potentially harmful constituent'' in the context of implementing the
HPHC list requirement under section 904(e) of the FD&C Act (76 FR 5387,
January 31, 2011). The guidance is available on the Internet at https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm241339.htm.
[[Page 70234]]
In addition, in the Federal Register of April 3, 2012 (77 FR 20034),
FDA published a notice (the HPHC list notice) announcing the
established list of HPHCs as required by section 904(e) of the FD&C Act
and describing the criteria we used in identifying the HPHCs for the
established list. Previously, FDA sought comment on both the criteria
that would be used to identify HPHCs for the established list and a
list of chemicals and chemical compounds that met the proposed
criteria.
The purpose of the information collection is to collect statutorily
mandated information regarding HPHCs in tobacco products and tobacco
smoke, by quantity in each brand and subbrand.
To facilitate the submission of HPHC information, FDA has developed
Forms 3787a, 3787b, and 3787c in both paper and electronic formats.
Manufacturers or importers, or their agents, may submit information
either electronically or in paper format. The FDA eSubmitter tool
provides electronic forms to streamline the data entry and submission
process for reporting HPHCs. Users of eSubmitter may populate an FDA-
created Excel file and import data into eSubmitter. Whether respondents
decide to submit reports electronically or on paper, each form provides
instructions for completing and submitting HPHC information to FDA. The
forms contain fields for company information, product information, and
HPHC information. Respondents finished reporting initial HPHC
information under section 904(a)(3) in 2012, and this collection of
information is in connection with the reporting requirements under
section 904(c)(1) of the FD&C Act for tobacco products introduced into
interstate commerce after June 22, 2009.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Information collected Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Reporting for Section 904(c)(1) Products
----------------------------------------------------------------------------------------------------------------
1. Reporting of Manufacturer Company and Product Information by Completing Submission Forms
Cigarette................... 78 0.79 62 1.82 113
Roll-Your-Own............... 39 0.21 8 0.43 3
Smokeless................... 52 0.21 11 0.63 7
-------------------------------------------------------------------------------
Total................... .............. .............. .............. .............. 123
----------------------------------------------------------------------------------------------------------------
2. Testing of HPHC Quantities in Products
----------------------------------------------------------------------------------------------------------------
Cigarette Filler............ 78 0.79 62 9.42 584
Roll-Your-Own............... 39 0.21 8 9.42 75
Smokeless................... 52 0.21 11 12.06 133
-------------------------------------------------------------------------------
Total................... .............. .............. .............. .............. 792
----------------------------------------------------------------------------------------------------------------
3. Testing of HPHC Quantities in Mainstream Smoke
----------------------------------------------------------------------------------------------------------------
Cigarette: International 78 0.79 62 23.64 1,466
Organization for
Standardization (ISO)
Regimen....................
Cigarette: Health Canada 78 0.79 62 23.64 1,466
Regimen....................
-------------------------------------------------------------------------------
Total................... .............. .............. .............. .............. 2,932
Total Section 904(c)(1) .............. .............. .............. .............. 3,847
Reporting Burden Hours.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating costs associated with this collection of information.
Table 1 contains estimates for new product information received
annually under section 904(c)(1) of the FD&C Act. Manufacturers must
report HPHC information under section 904(c)(1) of the FD&C Act at
least 90 days prior to delivery for introduction into interstate
commerce. The total annual burden for this collection of information is
estimated to be 3,847 hours. The burden estimate for this collection of
information includes the time it will take to test the products and
prepare the HPHC report.
Table 1 indicates that 169 respondents will submit HPHC reports
when new products enter the market. Section 1 of the table addresses
the time required for manufacturers to report their company
information. We estimate that the time to report HPHC information is no
more than 1.82 hours for cigarettes, 0.42 hours for roll-your-own, and
0.63 hours for smokeless tobacco products for each response regardless
of whether the paper or electronic form (Form FDA 3787) is used. (The
estimated times to report smokeless tobacco products (0.63 hour) and
roll-your-own tobacco products (0.43 hour) are lower than the estimated
reporting time for cigarette products because fewer HPHCs are normally
reported for these two types of products. The total annual burden for
reporting company and product information is 123 hours.
Section 2 of the table addresses the time required for
manufacturers to test quantities of HPHCs in their products. The burden
hour estimates include the time needed to test the tobacco products,
draft testing reports, and draft the report for FDA. For cigarette
filler, smokeless, and roll-your-own products, we estimate the burden
to be 792 annual burden hours. The burden for each product type
reflects our estimate of the time to test the tobacco products (i.e.,
carry out laboratory work).
In addition to addressing the time required to report information
and test quantities of HPHCs in tobacco products, section 3 of table 1
addresses the time required for manufacturers to test quantities of
HPHCs in cigarette smoke. The burden estimates include testing the
tobacco products, drafting testing reports, and drafting the report for
FDA. We estimate the annualized
[[Page 70235]]
burden for this section to be 2,932 hours. The annual burden reflects
our estimate to test the tobacco products (i.e., carry out laboratory
work). The burden estimate assumes that manufacturers report HPHC
quantities in cigarette mainstream smoke according to the two smoking
regimens described in the table.
The estimated total annual burden for the reporting of HPHC under
section 904(c)(1) of the FD&C Act is 3,847 hours. We do not believe
there are any capital costs associated with this collection.
Dated: November 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28787 Filed 11-12-15; 8:45 am]
BILLING CODE 4164-01-P
