Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act, 12501-12503 [2016-05213]
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Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices
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Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT: Lori
J. Churchyard, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Investigating and
Reporting Adverse Reactions Related to
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)
Regulated Solely under Section 361 of
the Public Health Service Act and 21
CFR part 1271; Guidance for Industry.’’
The guidance provides establishments
that manufacture HCT/Ps, with
recommendations for complying with
the requirements for investigating and
reporting adverse reactions involving
communicable disease in recipients of
HCT/Ps that are regulated solely under
section 361 of the Public Health Service
Act (PHS Act) and 21 CFR part 1271
(361 HCT/Ps).
In the Federal Register of February
20, 2015 (80 FR 9267), FDA announced
the availability of the draft guidance of
the same title dated February 2015. FDA
received several comments on the draft
guidance and those comments were
considered as the guidance was
finalized. In addition, editorial changes
were made to improve clarity.
The guidance supplements section
XXII of FDA’s guidance entitled
‘‘Guidance for Industry: Current Good
Tissue Practice (CGTP) and Additional
Requirements for Manufacturers of
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)’’ dated
December 2011 by providing additional
recommendations specific to the
responsibilities to investigate
complaints of adverse reactions
concerning 361 HCT/Ps under 21 CFR
1271.160(b)(2), 21 CFR 1271.320 and 21
CFR 1271.350(a)(1) and, supersedes the
guidance entitled ‘‘Guidance for
Industry: MedWatch Form FDA 3500A:
Mandatory Reporting of Adverse
Reactions Related to Human Cells,
Tissues, and Cellular and Tissue-Based
Products (HCT/Ps)’’ dated November
2005. The guidance provides updated
information specific to reporting
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adverse reactions related to HCT/Ps to
supplement the general instructions
accompanying the MedWatch
mandatory reporting form, Form FDA
3500A. The guidance announced in this
notice finalizes the draft guidance of the
same title dated February 2015.
The 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 Investigating and
Reporting Adverse Reactions Related to
Human Cells, Tissues, and Cellular and
Tissue-Based Products Regulated Solely
under Section 361 of the Public Health
Service Act and 21 CFR part 1271;
Guidance for Industry. 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.
II. Paperwork Reduction Act of 1995
The guidance refers to previously
approved collections of information
found in FDA regulations. 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
21 CFR part 1271 have been approved
under OMB control number 0910–0543;
and the collections of information in
MedWatch Form FDA 3500A has been
approved under OMB control number
0910–0291.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05215 Filed 3–8–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0049]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 8,
2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0732. Also
include the FDA docket number found
in brackets in the heading of this
document.
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
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
Food Drug and Cosmetic Act (the FD&C
Act) and granted FDA authority to
regulate the manufacture, marketing,
and distribution of tobacco products to
E:\FR\FM\09MRN1.SGM
09MRN1
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Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices
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 as
applicable, 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.
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.
In the Federal Register of November
13, 2015 (80 FR 70232), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. Four comments were
received; however, only one was PRA
related.
A comment stated that FDA has
dramatically underestimated the annual
number of responses that will be
submitted from tobacco product
manufacturers and importers. The
comment contended that our estimate
does not appear to be based on the
Agency’s experience with respect to
‘‘new’’ tobacco product submissions
under section 910 of the FD&C Act.
We have reconsidered our estimates,
and agree with what we understand the
comment to be saying, that we have not
accounted for the submission of the two
streamlined alternative substantial
equivalent (SE) reports, one for label
changes and one for product quantity
changes, referred to as the ‘‘Same
Characteristics SE Report’’ and the
‘‘Product Quantity Change SE Report,’’
respectively, and subsequent premarket
authorization for a ‘‘new tobacco
product’’ as defined under section
910(a)(1) of the FD&C Act (21 U.S.C.
387j(a)(1)). Based on FDA data, we
estimate between 500 and700 (i.e.,
approximately 600) new tobacco
products annually, as a result of
manufacturers and importers submitting
these streamlined submissions. We also
estimate that the report of HPHC data in
connection with these new tobacco
products will take approximately 1 hour
to prepare and submit. FDA has added
a new line in the table for this category
of new tobacco products.
A comment also stated that the
burden estimated for testing the
quantities of HPHCs in cigarette filler
and roll-your-own, smokeless, and
smoke as 9.42 hours, 12.06 hours and
23.64 hours respectively, per product,
has been dramatically underestimated.
The comment contends that HPHC
testing may more realistically be
expected to take 7 to 12 weeks per
product. FDA does not agree with this
comment. The Agency based its
estimates on its understanding as to
how long the tests themselves take, as
opposed to the length of time between
when a manufacturer or importer may
first request that a test be done and then
receives the test results from an internal
or independent laboratory.
Furthermore, a comment stated that
the burden estimated for the time
required to report HPHC information to
the Agency has been underestimated.
The comment contends that in one
entity’s experience, the time required to
report on the testing of a cigarette may
be expected to take around 200 hours,
taking into account the time required to
compile the requisite information and to
complete, review and edit the associated
form.
FDA disagrees with this comment as
we believe the estimates for testing the
quantities of HPHCs are accurate.
Additionally, we note that the comment
did not contain any data to support its
contention.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Lhorne on DSK5TPTVN1PROD with NOTICES
Information collected
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Reporting for Section 904(c)(1) Products
1. Reporting of Manufacturer/Importer Company and Product Information
by Completing Submission Forms:
Cigarette ..................................................................................................
Roll-Your-Own .........................................................................................
Smokeless ...............................................................................................
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78
39
52
Sfmt 4703
0.79
0.21
0.21
62
8
11
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09MRN1
1.82 ......................
0.43 (26 minutes)
0.63 (38 minutes)
113
3
7
12503
Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Information collected
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total ..................................................................................................
2. Testing of HPHC Quantities in Products:
Cigarette Filler .........................................................................................
Roll-Your-Own .........................................................................................
Smokeless ...............................................................................................
........................
........................
........................
..............................
123
78
39
52
0.79
0.21
0.21
62
8
11
9.42 ......................
9.42 ......................
12.06 ....................
584
75
133
Total ..................................................................................................
3. Testing of HPHC Quantities in Mainstream Smoke:
Cigarette: International Oraganization for Standardization (ISO) Regimen.
Cigarette: Health Canada Regimen ........................................................
........................
........................
........................
..............................
792
78
0.79
62
23.64 ....................
1,466
78
0.79
62
23.64 ....................
1,466
Total ..................................................................................................
4. Additional HPHC reports: 2
Cigarette Filler .........................................................................................
Roll-Your-Own .........................................................................................
Smokeless ...............................................................................................
........................
........................
........................
..............................
2,932
78
39
52
2.56
5.12
3.84
200
200
200
1 ...........................
1 ...........................
1 ...........................
200
200
200
Total ..................................................................................................
........................
........................
........................
..............................
600
Total Section 904(c)(1) Reporting Burden Hours .....................
........................
........................
........................
..............................
4,447
1 There
Lhorne on DSK5TPTVN1PROD with NOTICES
2 HPHC
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
reports for identical products (e.g., under different brand or sub-brand names) in which the HPHC measures will be the same as the original report.
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 4,447 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-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.
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,
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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
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.
As stated previously, FDA expects to
receive 600 additional HPHC reports at
1 hour per response for a total of 600
hours. The estimated total annual
burden for the reporting of HPHC under
section 904(c)(1) of the FD&C Act is
4,447 hours.
Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05213 Filed 3–8–16; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0735]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Superimposed
Text in Direct-to-Consumer Promotion
of Prescription Drugs
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
research entitled ‘‘Superimposed Text
in Direct-to-Consumer Promotion of
Prescription Drugs.’’ This study will
examine how the size and presentation
of superimposed text (supers) influences
the comprehension of direct-toconsumer (DTC) television
advertisements for prescription drugs.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by May 9, 2016.
DATES:
ADDRESSES:
You may submit comments
as follows:
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]]>Agencies
[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12501-12503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05213]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0049]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by April
8, 2016.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0732.
Also include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 Food Drug and Cosmetic Act (the FD&C Act) and granted FDA
authority to regulate the manufacture, marketing, and distribution of
tobacco products to
[[Page 12502]]
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 as applicable, 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 sub-brand. 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.
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 sub-brand.
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.
In the Federal Register of November 13, 2015 (80 FR 70232), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Four comments were received; however, only
one was PRA related.
A comment stated that FDA has dramatically underestimated the
annual number of responses that will be submitted from tobacco product
manufacturers and importers. The comment contended that our estimate
does not appear to be based on the Agency's experience with respect to
``new'' tobacco product submissions under section 910 of the FD&C Act.
We have reconsidered our estimates, and agree with what we
understand the comment to be saying, that we have not accounted for the
submission of the two streamlined alternative substantial equivalent
(SE) reports, one for label changes and one for product quantity
changes, referred to as the ``Same Characteristics SE Report'' and the
``Product Quantity Change SE Report,'' respectively, and subsequent
premarket authorization for a ``new tobacco product'' as defined under
section 910(a)(1) of the FD&C Act (21 U.S.C. 387j(a)(1)). Based on FDA
data, we estimate between 500 and700 (i.e., approximately 600) new
tobacco products annually, as a result of manufacturers and importers
submitting these streamlined submissions. We also estimate that the
report of HPHC data in connection with these new tobacco products will
take approximately 1 hour to prepare and submit. FDA has added a new
line in the table for this category of new tobacco products.
A comment also stated that the burden estimated for testing the
quantities of HPHCs in cigarette filler and roll-your-own, smokeless,
and smoke as 9.42 hours, 12.06 hours and 23.64 hours respectively, per
product, has been dramatically underestimated. The comment contends
that HPHC testing may more realistically be expected to take 7 to 12
weeks per product. FDA does not agree with this comment. The Agency
based its estimates on its understanding as to how long the tests
themselves take, as opposed to the length of time between when a
manufacturer or importer may first request that a test be done and then
receives the test results from an internal or independent laboratory.
Furthermore, a comment stated that the burden estimated for the
time required to report HPHC information to the Agency has been
underestimated. The comment contends that in one entity's experience,
the time required to report on the testing of a cigarette may be
expected to take around 200 hours, taking into account the time
required to compile the requisite information and to complete, review
and edit the associated form.
FDA disagrees with this comment as we believe the estimates for
testing the quantities of HPHCs are accurate. Additionally, we note
that the comment did not contain any data to support its contention.
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/
Importer 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 (26 3
minutes).
Smokeless................. 52 0.21 11 0.63 (38 7
minutes).
---------------------------------------------------------------------------------
[[Page 12503]]
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
Oraganization for
Standardization (ISO)
Regimen.
Cigarette: Health Canada 78 0.79 62 23.64........... 1,466
Regimen.
---------------------------------------------------------------------------------
Total................. .............. .............. .............. ................ 2,932
4. Additional HPHC reports:
\2\
Cigarette Filler.......... 78 2.56 200 1............... 200
Roll-Your-Own............. 39 5.12 200 1............... 200
Smokeless................. 52 3.84 200 1............... 200
---------------------------------------------------------------------------------
Total................. .............. .............. .............. ................ 600
---------------------------------------------------------------------------------
Total Section .............. .............. .............. ................ 4,447
904(c)(1)
Reporting Burden
Hours.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ HPHC reports for identical products (e.g., under different brand or sub-brand names) in which the HPHC
measures will be the same as the original report.
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 4,447 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 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.
As stated previously, FDA expects to receive 600 additional HPHC
reports at 1 hour per response for a total of 600 hours. The estimated
total annual burden for the reporting of HPHC under section 904(c)(1)
of the FD&C Act is 4,447 hours.
Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05213 Filed 3-8-16; 8:45 am]
BILLING CODE 4164-01-P
