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, 44636-44639 [2012-18442]
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44636
Federal Register / Vol. 77, No. 146 / Monday, July 30, 2012 / Notices
1.9 percent (which equals the 2.7
percent estimated RPL market basket
increase factor for FY 2013 reduced by
0.1 percentage points, and further
reduced by a 0.7 percent productivity
adjustment as required by section
1886(j)(3)(C)(ii)(I) of the Act).
We considered maintaining the
existing CMG relative weights and
average length of stay values for FY
2013. However, in light of recently
available data and our desire to ensure
that the CMG relative weights and
average length of stay values are as
reflective as possible of recent changes
in IRF utilization and case mix, we
believe that it is appropriate to update
the CMG relative weights and average
length of stay values at this time to
ensure that IRF PPS payments continue
to reflect as accurately as possible the
current costs of care in IRFs.
We considered maintaining the
existing outlier threshold amount for FY
2013. However, analysis of updated FY
2011 data indicates that estimated
outlier payments would be lower than 3
percent of total estimated payments for
FY 2012, by approximately 0.2 percent,
unless we updated the outlier threshold
amount. Consequently, we are adjusting
the outlier threshold amount in this
notice to reflect a 0.2 percent increase
thereby setting the total outlier
payments equal to 3 percent, instead of
2.8 percent, of aggregate estimated
payments in FY 2013.
E. Accounting Statement
As required by OMB Circular A–4
(available at https://www.whitehouse.
gov/sites/default/files/omb/assets/omb/
circulars/a004/a-4.pdf), in Table 8
below, we have prepared an accounting
statement showing the classification of
the expenditures associated with the
provisions of this notice. This table
provides our best estimate of the
increase in Medicare payments under
the IRF PPS as a result of the updates
presented in this notice based on the
data for 1,139 IRFs in our database.
TABLE 8—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES, FROM THE 2012 IRF PPS FISCAL
YEAR TO THE 2013 IRF PPS FISCAL YEAR
Category
Transfers
Annualized Monetized Transfers ..............................................................
From Whom to Whom? ............................................................................
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F. Conclusion
Overall, the estimated payments per
discharge for IRFs in FY 2013 are
projected to increase by 2.1 percent,
compared with the estimated payments
in FY 2012, as reflected in column 8 of
Table 7. IRF payments per discharge are
estimated to increase 2.0 percent in
urban areas and 2.2 percent in rural
areas, compared with estimated FY 2012
payments. Payments per discharge to
rehabilitation units are estimated to
increase 2.2 percent in urban areas and
2.3 percent in rural areas. Payments per
discharge to freestanding rehabilitation
hospitals are estimated to increase 1.9
percent in urban areas and 1.7 percent
in rural areas.
Overall, no IRFs are estimated to
experience a net decrease in payments
as a result of the updates in this notice.
The largest payment increase is
estimated to be a 3.2 percent increase
for rural IRFs located in the New
England region. This is due to the larger
than average positive effect of the FY
2013 CBSA wage index and laborrelated share updates for rural IRFs in
this region.
In accordance with the provisions of
Executive Order 12866, this notice was
reviewed by the Office of Management
and Budget.
Authority: (Catalog of Federal Domestic
Assistance Program No. 93.773, Medicare—
Hospital Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program).
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$140 million.
Federal Government to IRF Medicare Providers.
Dated: May 10, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Approved: July 16, 2012.
Kathleen Sebelius,
Secretary.
[FR Doc. 2012–18433 Filed 7–25–12; 4:15 pm]
BILLING CODE 4120–01–P
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
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 29,
2012.
SUMMARY:
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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–NEW and
title ‘‘Reporting Harmful and Potentially
Harmful Constituents in Tobacco
Products and Tobacco Smoke Under the
Federal Food, Drug, and Cosmetic Act.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@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.
ADDRESSES:
Reporting Harmful and Potentially
Harmful Constituents in Tobacco
Products and Tobacco Smoke Under
the Federal Food, Drug, and Cosmetic
Act—(OMB Control Number 0910–
NEW)
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Public Law
111–31) into law. This law amends the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) and grants FDA authority to
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Federal Register / Vol. 77, No. 146 / Monday, July 30, 2012 / Notices
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)) requires 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 final guidance discussing FDA’s
current thinking on the meaning of
‘‘harmful and potentially harmful
constituent’’ in the context of
implementing the HPHC list
requirement (76 FR 5387, January 31,
2011). The guidance is available on the
Internet at https://www.fda.gov/
TobaccoProducts/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.
In the Federal Register of April 3,
2012 (77 FR 20030), FDA announced the
availability of a draft guidance entitled
‘‘Guidance for Industry: Reporting
Harmful and Potentially Harmful
Constituents in Tobacco Products and
Tobacco Smoke Under Section 904(a)(3)
of the Federal Food, Drug, and Cosmetic
Act’’ (904(a)(3) draft guidance)
discussing the information to be
reported on HPHCs in tobacco products
and tobacco smoke under sections
904(a)(3) and (c)(1) of the FD&C Act.
The 904(a)(3) draft guidance discusses,
among other things: The statutory
requirement for testing and reporting
quantities of HPHCs, who tests and
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reports quantities of HPHCs to FDA,
what HPHCs will be the focus of FDA
enforcement at this time, when reports
are submitted to FDA, what information
is reported to FDA, and how the reports
should be submitted to FDA. The
904(a)(3) draft guidance notifies
manufacturers and importers that, at
this time, while industry is developing
laboratory capacity to comply with
section 904(a)(3) of the FD&C Act, FDA
does not intend to enforce the statutory
requirement to submit quantities of all
constituents identified by FDA as
HPHCs by June 22, 2012, where
manufacturers or importers complete
testing and reporting for an abbreviated
list of HPHCs as set forth in the
904(a)(3) draft guidance. In particular, at
this time, for products that were first
marketed before June 22, 2012, FDA
does not intend to enforce the section
904(a)(3) requirement to test and report
quantities of all HPHCs on FDA’s
established list where: (1) A
manufacturer or importer (or agents
thereof), other than a small tobacco
product manufacturer, submits
quantities of the HPHCs on an
abbreviated list described in the
guidance for all of its products, by brand
and subbrand, no later than September
22, 2012 or (2) a small tobacco product
manufacturer (or agents thereof) submits
quantities of HPHCS on the abbreviated
list for all of its products, by brand and
subbrand, by December 22, 2012. In
addition, for products first marketed on
or after June 22, 2012, the 904(a)(3) draft
guidance explains that FDA does not
intend, at this time, to enforce the
requirement in section 904(c)(1) of the
FD&C Act to test and report quantities
of all HPHCs on FDA’s established list
for products not previously on the
market if a manufacturer or importer
reports quantities for the abbreviated list
of HPHCs at least 90 days prior to
marketing the product in the United
States. The 904(a)(3) draft guidance
explains that, at this time, FDA intends
to enforce the HPHC reporting
requirements with respect to
manufacturers of finished tobacco
products for consumer use—cigarettes,
smokeless tobacco, and roll-your-own
tobacco—and not with respect to
manufacturers and importers of other
products, such as components sold to
manufacturers or consumers for
incorporation into finished products.
The purpose of the proposed
information collection is for FDA to
collect statutorily mandated information
regarding HPHCs in tobacco products
and tobacco smoke, by quantity in each
brand and subbrand. The 904(a)(3) draft
guidance provides an abbreviated list of
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HPHCs on which FDA intends to focus
enforcement at this time for each of the
following: Cigarette smoke, smokeless
tobacco products, and roll-your-own
tobacco and cigarette filler.
To facilitate the submission of HPHC
information, FDA has developed Form
3787 in both paper and electronic
formats. Manufacturers or importers, or
an agent, 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 also
populate an Excel file and import data
into eSubmitter. FDA also provides
paper forms for the submission of
section 904(a)(3) reports. FDA placed
draft copies of the paper forms and
screen shots of the electronic form and
spreadsheet in this docket. Whether
respondents decide to submit reports
electronically or on paper, each form
provides instructions for filling out and
submitting HPHC information to FDA.
The forms contain fields for company
information, product information, and
HPHC information (including the
specific HPHCs identified in the
904(a)(3) draft guidance).
The Federal Register notice
announcing the availability of the
904(a)(3) draft guidance included a
60-day notice requesting public
comment on the proposed collection of
information. FDA received 16 comments
that were PRA-related, including but not
limited to the following issues:
• Suggestions to enhance the quality,
utility, and clarity of the information to
be collected (i.e., comments specific to
FDA’s eSubmitter tool and paper forms);
• Cost associated with the collection
of information to comply with section
904(a)(3) of the FD&C Act, particularly
for small tobacco product
manufacturers; and
• Use of the proposed information
collection, especially because specific
test methods are not prescribed to
determine HPHC quantities.
Section 904(a)(3) of the FD&C Act
requires HPHC testing and reporting.
We have stated that we intend to
exercise enforcement discretion for
manufacturers who test for 20 rather
than 93 HPHCs at this time. In addition,
we have recognized that small tobacco
product manufacturers are likely to rely
on contract testing laboratories and
intend to exercise enforcement
discretion for those who submit
quantities of HPHCs 6 months after the
statutory deadline (i.e., December 22,
2012), and 3 months after submissions
by other tobacco product manufacturers.
Our abbreviated list of HPHCs, along
with the timeframes described in the
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draft guidance, represent a reasonable
approach to implementing section
904(a)(3) of the FD&C Act.
Based on comments received, FDA
has revised the instructions for FDA
Form 3787 to explain that if the HPHC
quantity is below the limit of detection
or limit of quantitation, zero should be
entered in the space identified for form.
We have also made minor cosmetic
changes to clarify instructions and to
allow accurate data entry. FDA has not
revised the burden estimate for this
collection of information.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses
per
respondent
Number of
respondents
Information collected
Total annual
responses
Average burden
per response
Total hours
Part 1—Section 904(a)(3) of the FD&C Act (Annualized estimate of one-time reporting) 2
1. Reporting of Manufacturer/Importer Company and
Product Information by Completing Submission Forms
Cigarette ...................................................................
Roll-Your-Own ..........................................................
Smokeless ................................................................
120
46
200
10.10
3.22
1.44
1,212
148
288
Total ...................................................................
........................
..........................
........................
..........................
3,296
Cigarette Filler ..........................................................
Roll-Your-Own ..........................................................
Smokeless ................................................................
120
46
200
10.1
3.22
1.44
1,212
148
288
9.42
9.42
12.06
11,417
1,394
3,473
Total ...................................................................
........................
..........................
........................
..........................
16,284
1,212
1,212
23.64
23.64
28,652
28,652
2
2
2
2,424
296
576
2. Testing of HPHC Quantities in Products
3. Testing of HPHC Quantities in Mainstream Smoke
Cigarette: International Organization for Standardization (ISO) Regimen ...........................................
Cigarette: Health Canada Regimen .........................
120
120
Total ...................................................................
........................
..........................
........................
..........................
57,304
Total Section 904(a)(3) Annualized OneTime Burden ...........................................
........................
..........................
........................
..........................
76,884
10.1
10.1
Part 2—Reporting of Section 904(c)(1) New Products (15% of One-Time Burden Totals) 3
1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
Cigarette ...................................................................
Roll-Your-Own ..........................................................
Smokeless ................................................................
18
7
30
10.10
3.22
1.44
182
23
43
2
2
2
364
46
86
Total ...................................................................
........................
..........................
........................
..........................
496
Cigarette Filler ..........................................................
Roll-Your-Own ..........................................................
Smokeless ................................................................
18
7
30
10.1
3.22
1.44
182
23
43
9.42
9.42
12.06
1,714
217
519
Total ...................................................................
........................
..........................
........................
..........................
2,450
182
182
23.64
23.64
4,302
4,302
2. Reporting of HPHC Quantities in Products
3. Reporting of HPHC Quantities in Mainstream Smoke
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Cigarette: ISO Regimen ...........................................
Cigarette: Health Canada Regimen .........................
18
18
10.1
10.1
Total ...................................................................
........................
..........................
........................
..........................
8,604
Total Section 904(c)(1) Burden ..................
........................
..........................
........................
..........................
11,550
Total Reporting Burden Hours ............
........................
..........................
........................
..........................
88,434
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 One-time actual first year burden hours have been annualized over the 3-year OMB period of approval to avoid over counting the burden
each year.
3 Annual new product reporting under section 904(c)(1) of the FD&C Act is estimated to be 15 percent of the annualized one-time burden.
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Federal Register / Vol. 77, No. 146 / Monday, July 30, 2012 / Notices
FDA estimates the one-time reporting
burden for this guidance would be
230,652 hours during the first year for
section 904(a)(3) of the FD&C Act
reporting plus ongoing annual burden of
11,550 hours for section 904(c)(1)
reporting. The burden estimate for this
collection of information includes the
time it will take to read the guidance
document, test the products, and
prepare the HPHC report.
To avoid overcounting the one-time
reporting burden, FDA has annualized
the one-time burden over the 3-year
expected OMB period of approval. The
annualized one-time burden of 76,884
hours is located in part one of table 1
of this document, and includes burden
for collections of information gathered
under section 904(a)(3) of the FD&C Act.
The total annual burden for this
collection of information is estimated to
be 88,434 hours, which is the
annualized one-time burden estimate for
section 904(a)(3) of the FD&C Act
associated with the submission of HPHC
reports and the annual burden estimate
for section 904(c)(1). Table 1 of this
document estimates 366 respondents
will submit HPHC reports on a one-time
basis. Table 1 of this document
addresses the time required for
manufacturers and importers to report
their company information. We estimate
that the burden is no more than 2 hours
per response to report company and
product information, regardless of
whether the paper or electronic form
(Form FDA 3787) is used. This estimate
is not dependent on product type, so the
estimated burden is the same for
cigarettes, roll-your-own tobacco, and
smokeless tobacco products. We also
estimate that 3,636 cigarette subbrands,
445 roll-your-own tobacco subbrands,
and 861 smokeless tobacco subbrands
(4,942 total subbrands) must comply
with section 904(a)(3) of the FD&C Act.
Therefore, the total annualized burden
for reporting company and product
information is 3,296 hours.
Table 1 of this document also
addresses the time required for
manufacturers and importers to report
quantities of HPHCs in their products.
The burden hour estimates include the
time needed to test the tobacco
products, draft testing reports, draft the
report for FDA, and submit the report to
FDA. For cigarette filler, smokeless, and
roll-your-own products, we estimate the
burden to test the product, draft testing
reports, draft the report for FDA, and
submit the report to FDA to be 16,284
annualized burden hours. The burden
for each product type reflects our
estimate of the burden to test the
tobacco products (i.e., carry out
laboratory work).
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In addition to addressing the time
required to report quantities of HPHCs
in tobacco products, table 1 of this
document addresses the time required
for manufacturers and importers to
report quantities for HPHCs in cigarette
smoke. The burden estimates include
testing the tobacco products, drafting
testing reports, drafting the report for
FDA, and submitting the report to FDA.
We estimate the annualized burden for
this section to be 57,304 hours. The
annualized burden reflects our estimate
of the burden to test the tobacco
products (i.e., carry out laboratory
work). The burden estimate assumes
that manufacturers and importers report
HPHC quantities in cigarette
mainstream smoke according to the two
recommended smoking regimens. The
total annualized burden for part one of
table 1 (section 904(a)(3) reporting) is
76,884 hours.
Table 1 of this document also
contains estimates for new product
information received annually under
section 904(c)(1) of the FD&C Act.
Manufacturers and importers 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. We estimate
that approximately 15 percent of FDA
currently regulated tobacco products in
any given year will require submission
of this information. The estimated total
annual burden for section 904(c)(1) of
the FD&C Act is 11,550 hours, which
includes reporting manufacturer/
importer company and product
information, reporting HPHC quantities
in products, and reporting HPHC
quantities in mainstream smoke.
The estimated total annual burden for
the reporting of HPHC under section
904(a)(3) and (c)(1) of the FD&C Act is
88,434 hours, which includes the
section 904(a)(3) annualized reporting
burden plus the section 904(c)(1) annual
reporting burden.
We have not estimated any capital
costs because we do not believe there
are any capital costs associated with this
collection. However, you may comment
on any specific capital costs that you
have identified.
Dated: July 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18442 Filed 7–27–12; 8:45 am]
BILLING CODE 4160–01–P
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44639
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pediatric
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 11, 2012, from 8:30
a.m. to 4 p.m.
Location: DoubleTree by Hilton Hotel,
8727 Colesville Rd., Silver Spring, MD
20910. The hotel’s telephone number is
301–589–5200.
Contact Person: Walter Ellenberg,
Office of Pediatric Therapeutics, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5154,
Silver Spring, MD. 20993, 301–796–
0885, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), to find out further information
regarding FDA advisory committee
information. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s Web
site at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: On September 11, 2012, the
Pediatric Advisory Committee will meet
to discuss pediatric-focused safety
reviews, as mandated by the Best
Pharmaceuticals for Children Act
(Public Law 107–109) and the Pediatric
Research Equity Act (Public Law 108–
155), for Kapvay (clonidine
hydrochloride), Vyvanse
(lisdexamfetamine dimesylate), Ofirmev
(acetaminophen), ella (ulipristal
acetate), Beyaz (drospirenone/ethinyl
estradiol/levomefolate calcium tablets
and levomefolate calcium tablets), Lo
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]]>Agencies
[Federal Register Volume 77, Number 146 (Monday, July 30, 2012)]
[Notices]
[Pages 44636-44639]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18442]
-----------------------------------------------------------------------
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 Paperwork
Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
29, 2012.
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-NEW and
title ``Reporting Harmful and Potentially Harmful Constituents in
Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and
Cosmetic Act.'' Also include the FDA docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@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-NEW)
On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Public Law 111-31) into law. This
law amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) and
grants FDA authority to
[[Page 44637]]
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))
requires 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 final guidance
discussing FDA's current thinking on the meaning of ``harmful and
potentially harmful constituent'' in the context of implementing the
HPHC list requirement (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.
In the Federal Register of April 3, 2012 (77 FR 20030), FDA
announced the availability of a draft guidance entitled ``Guidance for
Industry: Reporting Harmful and Potentially Harmful Constituents in
Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the
Federal Food, Drug, and Cosmetic Act'' (904(a)(3) draft guidance)
discussing the information to be reported on HPHCs in tobacco products
and tobacco smoke under sections 904(a)(3) and (c)(1) of the FD&C Act.
The 904(a)(3) draft guidance discusses, among other things: The
statutory requirement for testing and reporting quantities of HPHCs,
who tests and reports quantities of HPHCs to FDA, what HPHCs will be
the focus of FDA enforcement at this time, when reports are submitted
to FDA, what information is reported to FDA, and how the reports should
be submitted to FDA. The 904(a)(3) draft guidance notifies
manufacturers and importers that, at this time, while industry is
developing laboratory capacity to comply with section 904(a)(3) of the
FD&C Act, FDA does not intend to enforce the statutory requirement to
submit quantities of all constituents identified by FDA as HPHCs by
June 22, 2012, where manufacturers or importers complete testing and
reporting for an abbreviated list of HPHCs as set forth in the
904(a)(3) draft guidance. In particular, at this time, for products
that were first marketed before June 22, 2012, FDA does not intend to
enforce the section 904(a)(3) requirement to test and report quantities
of all HPHCs on FDA's established list where: (1) A manufacturer or
importer (or agents thereof), other than a small tobacco product
manufacturer, submits quantities of the HPHCs on an abbreviated list
described in the guidance for all of its products, by brand and
subbrand, no later than September 22, 2012 or (2) a small tobacco
product manufacturer (or agents thereof) submits quantities of HPHCS on
the abbreviated list for all of its products, by brand and subbrand, by
December 22, 2012. In addition, for products first marketed on or after
June 22, 2012, the 904(a)(3) draft guidance explains that FDA does not
intend, at this time, to enforce the requirement in section 904(c)(1)
of the FD&C Act to test and report quantities of all HPHCs on FDA's
established list for products not previously on the market if a
manufacturer or importer reports quantities for the abbreviated list of
HPHCs at least 90 days prior to marketing the product in the United
States. The 904(a)(3) draft guidance explains that, at this time, FDA
intends to enforce the HPHC reporting requirements with respect to
manufacturers of finished tobacco products for consumer use--
cigarettes, smokeless tobacco, and roll-your-own tobacco--and not with
respect to manufacturers and importers of other products, such as
components sold to manufacturers or consumers for incorporation into
finished products.
The purpose of the proposed information collection is for FDA to
collect statutorily mandated information regarding HPHCs in tobacco
products and tobacco smoke, by quantity in each brand and subbrand. The
904(a)(3) draft guidance provides an abbreviated list of HPHCs on which
FDA intends to focus enforcement at this time for each of the
following: Cigarette smoke, smokeless tobacco products, and roll-your-
own tobacco and cigarette filler.
To facilitate the submission of HPHC information, FDA has developed
Form 3787 in both paper and electronic formats. Manufacturers or
importers, or an agent, 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 also populate an Excel file and import data
into eSubmitter. FDA also provides paper forms for the submission of
section 904(a)(3) reports. FDA placed draft copies of the paper forms
and screen shots of the electronic form and spreadsheet in this docket.
Whether respondents decide to submit reports electronically or on
paper, each form provides instructions for filling out and submitting
HPHC information to FDA. The forms contain fields for company
information, product information, and HPHC information (including the
specific HPHCs identified in the 904(a)(3) draft guidance).
The Federal Register notice announcing the availability of the
904(a)(3) draft guidance included a 60-day notice requesting public
comment on the proposed collection of information. FDA received 16
comments that were PRA-related, including but not limited to the
following issues:
Suggestions to enhance the quality, utility, and clarity
of the information to be collected (i.e., comments specific to FDA's
eSubmitter tool and paper forms);
Cost associated with the collection of information to
comply with section 904(a)(3) of the FD&C Act, particularly for small
tobacco product manufacturers; and
Use of the proposed information collection, especially
because specific test methods are not prescribed to determine HPHC
quantities.
Section 904(a)(3) of the FD&C Act requires HPHC testing and
reporting. We have stated that we intend to exercise enforcement
discretion for manufacturers who test for 20 rather than 93 HPHCs at
this time. In addition, we have recognized that small tobacco product
manufacturers are likely to rely on contract testing laboratories and
intend to exercise enforcement discretion for those who submit
quantities of HPHCs 6 months after the statutory deadline (i.e.,
December 22, 2012), and 3 months after submissions by other tobacco
product manufacturers. Our abbreviated list of HPHCs, along with the
timeframes described in the
[[Page 44638]]
draft guidance, represent a reasonable approach to implementing section
904(a)(3) of the FD&C Act.
Based on comments received, FDA has revised the instructions for
FDA Form 3787 to explain that if the HPHC quantity is below the limit
of detection or limit of quantitation, zero should be entered in the
space identified for form. We have also made minor cosmetic changes to
clarify instructions and to allow accurate data entry. FDA has not
revised the burden estimate for this collection of information.
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
----------------------------------------------------------------------------------------------------------------
Part 1--Section 904(a)(3) of the FD&C Act (Annualized estimate of one-time reporting) \2\
----------------------------------------------------------------------------------------------------------------
1. Reporting of Manufacturer/
Importer Company and Product
Information by Completing
Submission Forms
Cigarette................... 120 10.10 1,212 2 2,424
Roll-Your-Own............... 46 3.22 148 2 296
Smokeless................... 200 1.44 288 2 576
-------------------------------------------------------------------------------
Total................... .............. .............. .............. .............. 3,296
----------------------------------------------------------------------------------------------------------------
2. Testing of HPHC Quantities in Products
----------------------------------------------------------------------------------------------------------------
Cigarette Filler............ 120 10.1 1,212 9.42 11,417
Roll-Your-Own............... 46 3.22 148 9.42 1,394
Smokeless................... 200 1.44 288 12.06 3,473
-------------------------------------------------------------------------------
Total................... .............. .............. .............. .............. 16,284
----------------------------------------------------------------------------------------------------------------
3. Testing of HPHC Quantities in Mainstream Smoke
----------------------------------------------------------------------------------------------------------------
Cigarette: International 120 10.1 1,212 23.64 28,652
Organization for
Standardization (ISO)
Regimen....................
Cigarette: Health Canada 120 10.1 1,212 23.64 28,652
Regimen....................
-------------------------------------------------------------------------------
Total................... .............. .............. .............. .............. 57,304
-------------------------------------------------------------------------------
Total Section .............. .............. .............. .............. 76,884
904(a)(3)
Annualized One-Time
Burden.............
----------------------------------------------------------------------------------------------------------------
Part 2--Reporting of Section 904(c)(1) New Products (15% of One-Time Burden Totals) \3\
----------------------------------------------------------------------------------------------------------------
1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
----------------------------------------------------------------------------------------------------------------
Cigarette................... 18 10.10 182 2 364
Roll-Your-Own............... 7 3.22 23 2 46
Smokeless................... 30 1.44 43 2 86
-------------------------------------------------------------------------------
Total................... .............. .............. .............. .............. 496
----------------------------------------------------------------------------------------------------------------
2. Reporting of HPHC Quantities in Products
----------------------------------------------------------------------------------------------------------------
Cigarette Filler............ 18 10.1 182 9.42 1,714
Roll-Your-Own............... 7 3.22 23 9.42 217
Smokeless................... 30 1.44 43 12.06 519
-------------------------------------------------------------------------------
Total................... .............. .............. .............. .............. 2,450
----------------------------------------------------------------------------------------------------------------
3. Reporting of HPHC Quantities in Mainstream Smoke
----------------------------------------------------------------------------------------------------------------
Cigarette: ISO Regimen...... 18 10.1 182 23.64 4,302
Cigarette: Health Canada 18 10.1 182 23.64 4,302
Regimen....................
-------------------------------------------------------------------------------
Total................... .............. .............. .............. .............. 8,604
-------------------------------------------------------------------------------
Total Section .............. .............. .............. .............. 11,550
904(c)(1) Burden...
-------------------------------------------------------------------------------
Total Reporting .............. .............. .............. .............. 88,434
Burden Hours...
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ One-time actual first year burden hours have been annualized over the 3-year OMB period of approval to avoid
over counting the burden each year.
\3\ Annual new product reporting under section 904(c)(1) of the FD&C Act is estimated to be 15 percent of the
annualized one-time burden.
[[Page 44639]]
FDA estimates the one-time reporting burden for this guidance would
be 230,652 hours during the first year for section 904(a)(3) of the
FD&C Act reporting plus ongoing annual burden of 11,550 hours for
section 904(c)(1) reporting. The burden estimate for this collection of
information includes the time it will take to read the guidance
document, test the products, and prepare the HPHC report.
To avoid overcounting the one-time reporting burden, FDA has
annualized the one-time burden over the 3-year expected OMB period of
approval. The annualized one-time burden of 76,884 hours is located in
part one of table 1 of this document, and includes burden for
collections of information gathered under section 904(a)(3) of the FD&C
Act. The total annual burden for this collection of information is
estimated to be 88,434 hours, which is the annualized one-time burden
estimate for section 904(a)(3) of the FD&C Act associated with the
submission of HPHC reports and the annual burden estimate for section
904(c)(1). Table 1 of this document estimates 366 respondents will
submit HPHC reports on a one-time basis. Table 1 of this document
addresses the time required for manufacturers and importers to report
their company information. We estimate that the burden is no more than
2 hours per response to report company and product information,
regardless of whether the paper or electronic form (Form FDA 3787) is
used. This estimate is not dependent on product type, so the estimated
burden is the same for cigarettes, roll-your-own tobacco, and smokeless
tobacco products. We also estimate that 3,636 cigarette subbrands, 445
roll-your-own tobacco subbrands, and 861 smokeless tobacco subbrands
(4,942 total subbrands) must comply with section 904(a)(3) of the FD&C
Act. Therefore, the total annualized burden for reporting company and
product information is 3,296 hours.
Table 1 of this document also addresses the time required for
manufacturers and importers to report quantities of HPHCs in their
products. The burden hour estimates include the time needed to test the
tobacco products, draft testing reports, draft the report for FDA, and
submit the report to FDA. For cigarette filler, smokeless, and roll-
your-own products, we estimate the burden to test the product, draft
testing reports, draft the report for FDA, and submit the report to FDA
to be 16,284 annualized burden hours. The burden for each product type
reflects our estimate of the burden to test the tobacco products (i.e.,
carry out laboratory work).
In addition to addressing the time required to report quantities of
HPHCs in tobacco products, table 1 of this document addresses the time
required for manufacturers and importers to report quantities for HPHCs
in cigarette smoke. The burden estimates include testing the tobacco
products, drafting testing reports, drafting the report for FDA, and
submitting the report to FDA. We estimate the annualized burden for
this section to be 57,304 hours. The annualized burden reflects our
estimate of the burden to test the tobacco products (i.e., carry out
laboratory work). The burden estimate assumes that manufacturers and
importers report HPHC quantities in cigarette mainstream smoke
according to the two recommended smoking regimens. The total annualized
burden for part one of table 1 (section 904(a)(3) reporting) is 76,884
hours.
Table 1 of this document also contains estimates for new product
information received annually under section 904(c)(1) of the FD&C Act.
Manufacturers and importers 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. We estimate that approximately
15 percent of FDA currently regulated tobacco products in any given
year will require submission of this information. The estimated total
annual burden for section 904(c)(1) of the FD&C Act is 11,550 hours,
which includes reporting manufacturer/importer company and product
information, reporting HPHC quantities in products, and reporting HPHC
quantities in mainstream smoke.
The estimated total annual burden for the reporting of HPHC under
section 904(a)(3) and (c)(1) of the FD&C Act is 88,434 hours, which
includes the section 904(a)(3) annualized reporting burden plus the
section 904(c)(1) annual reporting burden.
We have not estimated any capital costs because we do not believe
there are any capital costs associated with this collection. However,
you may comment on any specific capital costs that you have identified.
Dated: July 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18442 Filed 7-27-12; 8:45 am]
BILLING CODE 4160-01-P
