Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products, 46441-46443 [2012-18975]
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TKELLEY on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 150 / Friday, August 3, 2012 / Notices
MAC with appropriate documentation
and all relevant Medicare coverage and
documentation requirements are met for
the PMD, then the DME MAC sends an
affirmative prior authorization decision
to the physician or treating practitioner,
supplier, and Medicare beneficiary.
When the claim is submitted to the DME
MAC by the supplier, it is linked to the
Prior Authorization via the claims
processing system and so long as all
applicable requirements in the
applicable NCD/LCD are met, the claim
is paid.
• Scenario 2: When a submitter sends
a prior authorization request but all
relevant Medicare coverage
requirements are not met for the PMD,
then the DME MAC sends a
nonaffirmative prior authorization
decision to the physician or treating
practitioner, supplier, and Medicare
beneficiary advising them that Medicare
will not pay for the item. A supplier can
deliver the PMD, and submit a claim
with a non-affirmative prior
authorization decision, at which point
the DME MAC would deny the claim.
The supplier and/or the beneficiary
would then have the Medicare denial
for secondary insurance purposes and
would have full appeal rights.
If an applicable PMD claim is
submitted without a prior authorization
decision it will be stopped and
documentation will be requested to
conduct medical review. After the first
3 months of the demonstration, we will
assess a payment reduction for claims
that, after review, are deemed payable,
but did not first receive a prior
authorization decision. As evidence of
compliance, the supplier must submit
the prior authorization number on the
claim in order to avoid a 25 percent
payment reduction. The 25 percent
payment reduction is non-transferrable
to the beneficiary and not subject to
appeal. In the case of capped rental
items, the payment reduction will be
applied to all claims in the series.
The 25-percent reduction in the
Medicare payment is for each payable
base claim not preceded by a prior
authorization request except in
competitive bidding areas. If a
competitive bid contract supplier
submits a payable claim for a
beneficiary with a permanent residence
in a competitive bidding area, that is
included in the supplier’s contract,
without first receiving a prior
authorization decision, that competitive
bid supplier would receive the
applicable single payment amount
under the competitive bid program, and
would not be subject to the 25-percent
reduction. These suppliers must still
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17:33 Aug 02, 2012
Jkt 226001
adhere to all other requirements of the
demonstration.
• Scenario 3: When a submitter sends
a prior authorization request where
documentation is incomplete, the prior
authorization request is sent back to the
submitter with an explanation about
what information is missing. The
submitter can rectify the situation and
resubmit the prior authorization request.
The physician or treating practitioner,
supplier, and Medicare beneficiary are
also notified.
• Scenario 4: When the DME supplier
fails to receive a prior authorization
decision, but nonetheless delivers the
item to the beneficiary and submits the
claim to the DME MAC for payment, the
PMD claim will be reviewed under
normal medical review processing
timeframes.
++ If the claim is determined to be not
medically necessary or insufficiently
documented, the claim will be denied.
The supplier and/or beneficiary can
appeal the claim denial. If the claim,
after review, is deemed not payable then
all current beneficiary/supplier liability
policies and procedures as well as
appeal rights remain in effect.
++ If the claim is determined to be
payable, it will be paid. However, 3
months after the start of the
demonstration, a 25-percent reduction
in the Medicare Payment will be
applied for failure to receive a prior
authorization decision before the
submission of a claim. This payment
reduction will not be applied for
competitive bidding program contract
suppliers submitting claims for
beneficiaries who maintain a permanent
residence in a Competitive Bidding Area
in their contracts according to the
Common Working File (CWF)); these
contract suppliers will continue to
receive the applicable single payment
amount under their contracts. The 25percent payment reduction is nontransferrable to the beneficiary for the
claims that are deemed payable. This
payment reduction will begin 3 months
after the start of the demonstration and
is not subject to appeal. In the case of
capped rental items the payment
reduction will be applied to all claims
in the series. After a claim is submitted
and processed, appeal rights are
available as they normally are.
Under the demonstration, we will
work to limit the impact on
beneficiaries. We will educate
beneficiaries as part of this protection.
If the prior authorization request is not
affirmed, and the claim is still
submitted by the supplier, the claim
will be denied in full, but beneficiaries
will continue to have all normal appeal
rights as well as the option of signing an
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46441
Advance Beneficiary Notice in order to
receive and be liable for payment for a
denied PMD.
Additional information is available on
the CMS Web site at go.cms.gov/
PAdemo.
IV. Collection of Information
Requirements
We announced and solicited
comments for the information collection
requirements associated with the
Medicare Prior Authorization for Power
Mobility Device (PMD) Demonstration
for certain PMD codes in 60-day and 30day Federal Register notices that
published on February 7, 2012 (77 FR
6124) and May 29, 2012 (77 FR 31616),
respectively. The information collection
requirements are approved under OMB
control number 0938–1169.
Authority: Section 402(a)(1)(J) of the
Social Security Amendments of 1967.
Dated: July 30, 2012
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2012–19014 Filed 8–1–12; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0386]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Registration and
Product Listing for Owners and
Operators of Domestic Tobacco
Product Establishments and Listing of
Ingredients in Tobacco Products
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 September
4, 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
SUMMARY:
E:\FR\FM\03AUN1.SGM
03AUN1
46442
Federal Register / Vol. 77, No. 150 / Friday, August 3, 2012 / Notices
comments should be identified with the
OMB control number 0910–0650. 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.
Registration and Product Listing for
Owners and Operators of Domestic
Tobacco Product Establishments and
Listing of Ingredients in Tobacco
Products (OMB Control Number 0910–
0650)—Extension
On June 22, 2009, the President
signed the Tobacco Control Act (Pub. L.
111–31) into law. The Tobacco Control
Act amended the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 301 et seq.) by, among other
things, adding a new chapter granting
FDA important authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Section 905(b) of the FD&C Act (21
U.S.C. 387e(b)), as amended by the
Tobacco Control Act, requires that
‘‘every person who owns or operates
any establishment in any State engaged
in the manufacture, preparation,
compounding, or processing of a
tobacco product or tobacco products
* * *’’ register with FDA the name,
places of business, and all
establishments owned or operated by
that person. Every person must register
by December 31 of each year. Section
905(c) of the FD&C Act requires that
first-time persons ‘‘engaging in the
manufacture, preparation,
compounding, or processing of a
tobacco product or tobacco products
shall register with the Secretary the
name, places of business, and all such
establishments of that person.’’ Section
905(d) states that persons required to
register under sections 905(b) or 905(c)
shall register any additional
establishment that they own or operate
in any state which begins the
manufacture, preparation,
compounding, or processing of a
tobacco product or tobacco products.
Section 905(h) addresses foreign
establishment registration requirements,
which will go into effect when
regulations are promulgated by the
Secretary. Section 905(i)(1) of the FD&C
Act, as amended by the Tobacco Control
Act, requires that all registrants ‘‘shall,
at the time of registration under any
such subsection, file with [FDA] a list of
all tobacco products which are being
manufactured, prepared, compounded,
or processed by that person for
commercial distribution,’’ along with
certain accompanying consumer
information, such as all labeling and a
representative sampling of
advertisements. Section 904(a)(1) of the
FD&C Act (21 U.S.C. 387d(a)(1)), as
amended by the Tobacco Control Act,
requires each tobacco product
manufacturer or importer, or agent
thereof, to submit ‘‘a listing of all
ingredients, including tobacco,
substances, compounds, and additives
that are * * * added by the
manufacturer to the tobacco, paper,
filter, or other part of each tobacco
product by brand or by quantity in each
brand and subbrand.’’ Since the
Tobacco Control Act was enacted on
June 22, 2009, the information required
under section 904(a)(1) must be
submitted to FDA by December 22,
2009, and include the ingredients added
as of the date of submission. Section
904(c) of the FD&C Act also requires
submission of information whenever
additives, or the quantities of additives,
are changed.
FDA issued guidance documents on
both: (1) Registration and Product
Listing for Owners and Operators of
Domestic Tobacco Product
Establishments (November 12, 2009; 74
FR 58298) and (2) Listing of Ingredients
in Tobacco Products (December 1, 2009;
74 FR 62795) to assist persons making
such submissions to FDA under the
Tobacco Control Act. While electronic
submission of registration and product
listing information and ingredient
listing information are not required,
FDA is strongly encouraging electronic
submission to facilitate efficiency and
timeliness of data management and
collection. To that end, FDA designed
the eSubmitter application to streamline
the data entry process for registration
and product listing and for ingredient
listing. This tool allows for importation
of large quantities of structured data,
attachment of files (e.g., in portable
document format (PDFs) and certain
media files), and automatic
acknowledgement of FDA’s receipt of
submissions. FDA also developed paper
forms (Form FDA 3742—Registration
and Listing for Owners and Operators of
Domestic Tobacco Product
Establishments and Form FDA 3743—
Listing of Ingredients in Tobacco
Products) as an alternative submission
tool. Both the eSubmitter application
and the paper forms can be accessed at
https://www.fda.gov/tobacco.
In the Federal Register of May 3, 2012
(77 FR 26281), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
One comment beyond the scope of this
collection was received that discussed
the importance of extending this
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
TKELLEY on DSK3SPTVN1PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
FDA form/activity/tobacco control act section
Average
burden per
response
Total annual
responses
Total hours
Form FDA 3742/Registration and Product Listing for Owners and Operators of Domestic Establishments (Electronic and Paper submission)/Sections 905(b), 905(c),
905(d) 905(h), or 905(i).
Form FDA 3743/Listing of Ingredients (Electronic and
Paper Submissions)/Sections 904(a)(1) or 904(c).
Obtaining a DUNS Number (10% of total respondents) ......
125
1.6
200
3.75
750
125
1.6
200
3
600
Total ..............................................................................
........................
1 There
8
1
..........................
8
0.50 (30 minutes)
4
........................
.....................
1,354
are no capital costs or operating and maintenance costs associated with this collection of information.
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TKELLEY on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 150 / Friday, August 3, 2012 / Notices
Since this collection of information
was last approved by OMB on December
2, 2010, its burden has decreased by
407,421 hours, from 408,775 to 1,354
reporting hours. This adjustment is a
result of FDA experience over the past
2 years in the regulation of tobacco
products and is based on the actual
number of establishment registration
and product ingredient submissions
received during this time period. In
2010, when this collection was first
published for public comment in the
Federal Register, FDA attempted to
determine the actual number of tobacco
manufacturers by using the Security and
Exchange Commission’s Standard
Industrial Classification (SIC) codes,
which are identifying codes that appear
in a company’s EDGAR filings to show
the company’s type of business. When
preparing the collection of information
package for publication in 2010, the
tobacco industry codes indicated that
over 10,000 tobacco manufacturers
existed under the SIC codes for tobacco
products and cigarettes. However, upon
further examination of these codes, it
appears that the number of tobacco
manufacturers was greatly inflated, as
the SIC codes included tobacco retail in
addition to tobacco manufacturers. In
addition, no comments were received
from the 2010 initial 60-day Federal
Register notice regarding either the
number of respondents or the number of
reporting burden hours listed in the
notice, so FDA used the collection’s
SIC-researched manufacturer numbers
for this collection of information. Actual
FDA registration and product listing
report submissions and FDA experience
indicate in the past 2 years, the number
of tobacco manufacturers required to
register and list their products and
ingredient listings is approximately 125,
a substantial decrease from the number
of potential respondents listed in 2010.
By applying the revised number of
manufacturers to the burden chart, the
total burden for registration and listing
now is currently estimated to be 1,354
reporting burden hours, much less than
the 408,775 OMB-approved reporting
burden hours stated in 2010.
Based on the actual number of
registration and product ingredient
listing reports received by FDA over the
past 2 years, the number of expected
annual responses is projected to
decrease from 100,000 registration
responses to 200 annual responses, and
from 11,000 annual product ingredient
listing responses to 200 annual product
ingredient responses. The Agency bases
its estimate on the actual number of
registration and listing and product
ingredient listing reports received, its
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experience with the submission of
registration and listing requirements
applicable to other FDA regulated
products, and ongoing interactions with
industry. FDA estimates that the
submission of registration information
as required by section 905 of the FD&C
Act will remain at 3.75 hours per
establishment. Based on the actual
number of registration information
submitted in the past 2 years and its
experience, the Agency estimates that
approximately 200 registrations will be
submitted from 125 tobacco product
establishments annually, for a total 750
hour burden (125 respondents × 1.6
responses per respondent × 3.75 hours
per response).
FDA estimates that the submission of
ingredient listing information as
required by section 904 of the FD&C Act
will remain at 3.0 hours per tobacco
product. Based on the actual number of
product ingredient listings submitted
over the past 2 years and its experience,
the Agency estimates that
approximately 200 ingredient listings
will be submitted from 125 tobacco
establishments, for a total 600 burden
hours (125 respondents × 1.6 responses
per respondent × 3.0 hours per
response).
FDA estimates that obtaining a Dun
and Bradstreet (DUNS) number will take
0.5 hours, and that 8 respondents (1
percent (1.25) of establishments
required to register under section 905
and 5 percent (6.25) of submitters
required to list ingredients under
section 904) will not already have a
DUNS number. The total burden,
therefore, will be 4 hours (8 respondents
× 1 response per respondent × 0.5 hours
per response).
Total burden hours for this collection,
therefore is 1,354 hours (750 + 600 + 4
hours).
Dated: July 30, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18975 Filed 8–2–12; 8:45 am]
BILLING CODE 4160–01–P
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46443
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0627]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
General Administrative Procedures:
Citizen Petitions; Petition for
Reconsideration or Stay of Action;
Advisory Opinions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘General Administrative Procedures:
Citizen Petitions; Petition for
Reconsideration or Stay of Action;
Advisory Opinions’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
SUMMARY:
Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, ila.mizrachi@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On March
27, 2012, the Agency submitted a
proposed collection of information
entitled ’’ General Administrative
Procedures: Citizen Petitions; Petition
for Reconsideration or Stay of Action;
Advisory Opinions’’ 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 0910–0183. The
approval expires on June 30, 2014. 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: July 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18976 Filed 8–2–12; 8:45 am]
BILLING CODE 4160–01–P
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]]>Agencies
[Federal Register Volume 77, Number 150 (Friday, August 3, 2012)]
[Notices]
[Pages 46441-46443]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18975]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0386]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Registration and
Product Listing for Owners and Operators of Domestic Tobacco Product
Establishments and Listing of Ingredients in Tobacco Products
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
September 4, 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
[[Page 46442]]
comments should be identified with the OMB control number 0910-0650.
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.
Registration and Product Listing for Owners and Operators of Domestic
Tobacco Product Establishments and Listing of Ingredients in Tobacco
Products (OMB Control Number 0910-0650)--Extension
On June 22, 2009, the President signed the Tobacco Control Act
(Pub. L. 111-31) into law. The Tobacco Control Act amended the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.) by,
among other things, adding a new chapter granting FDA important
authority to regulate the manufacture, marketing, and distribution of
tobacco products to protect the public health generally and to reduce
tobacco use by minors.
Section 905(b) of the FD&C Act (21 U.S.C. 387e(b)), as amended by
the Tobacco Control Act, requires that ``every person who owns or
operates any establishment in any State engaged in the manufacture,
preparation, compounding, or processing of a tobacco product or tobacco
products * * *'' register with FDA the name, places of business, and
all establishments owned or operated by that person. Every person must
register by December 31 of each year. Section 905(c) of the FD&C Act
requires that first-time persons ``engaging in the manufacture,
preparation, compounding, or processing of a tobacco product or tobacco
products shall register with the Secretary the name, places of
business, and all such establishments of that person.'' Section 905(d)
states that persons required to register under sections 905(b) or
905(c) shall register any additional establishment that they own or
operate in any state which begins the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco products.
Section 905(h) addresses foreign establishment registration
requirements, which will go into effect when regulations are
promulgated by the Secretary. Section 905(i)(1) of the FD&C Act, as
amended by the Tobacco Control Act, requires that all registrants
``shall, at the time of registration under any such subsection, file
with [FDA] a list of all tobacco products which are being manufactured,
prepared, compounded, or processed by that person for commercial
distribution,'' along with certain accompanying consumer information,
such as all labeling and a representative sampling of advertisements.
Section 904(a)(1) of the FD&C Act (21 U.S.C. 387d(a)(1)), as amended by
the Tobacco Control Act, requires each tobacco product manufacturer or
importer, or agent thereof, to submit ``a listing of all ingredients,
including tobacco, substances, compounds, and additives that are * * *
added by the manufacturer to the tobacco, paper, filter, or other part
of each tobacco product by brand or by quantity in each brand and
subbrand.'' Since the Tobacco Control Act was enacted on June 22, 2009,
the information required under section 904(a)(1) must be submitted to
FDA by December 22, 2009, and include the ingredients added as of the
date of submission. Section 904(c) of the FD&C Act also requires
submission of information whenever additives, or the quantities of
additives, are changed.
FDA issued guidance documents on both: (1) Registration and Product
Listing for Owners and Operators of Domestic Tobacco Product
Establishments (November 12, 2009; 74 FR 58298) and (2) Listing of
Ingredients in Tobacco Products (December 1, 2009; 74 FR 62795) to
assist persons making such submissions to FDA under the Tobacco Control
Act. While electronic submission of registration and product listing
information and ingredient listing information are not required, FDA is
strongly encouraging electronic submission to facilitate efficiency and
timeliness of data management and collection. To that end, FDA designed
the eSubmitter application to streamline the data entry process for
registration and product listing and for ingredient listing. This tool
allows for importation of large quantities of structured data,
attachment of files (e.g., in portable document format (PDFs) and
certain media files), and automatic acknowledgement of FDA's receipt of
submissions. FDA also developed paper forms (Form FDA 3742--
Registration and Listing for Owners and Operators of Domestic Tobacco
Product Establishments and Form FDA 3743--Listing of Ingredients in
Tobacco Products) as an alternative submission tool. Both the
eSubmitter application and the paper forms can be accessed at https://www.fda.gov/tobacco.
In the Federal Register of May 3, 2012 (77 FR 26281), FDA published
a 60-day notice requesting public comment on the proposed collection of
information. One comment beyond the scope of this collection was
received that discussed the importance of extending this collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
FDA form/activity/tobacco Number of responses per Total annual Average burden Total hours
control act section respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Form FDA 3742/Registration 125 1.6 200 3.75 750
and Product Listing for
Owners and Operators of
Domestic Establishments
(Electronic and Paper
submission)/Sections 905(b),
905(c), 905(d) 905(h), or
905(i).
Form FDA 3743/Listing of 125 1.6 200 3 600
Ingredients (Electronic and
Paper Submissions)/Sections
904(a)(1) or 904(c).
Obtaining a DUNS Number (10% 8 1 8 0.50 (30 4
of total respondents). minutes)
----------------------------------------------------------------------------------
Total.................... .............. ............... .............. ................ 1,354
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 46443]]
Since this collection of information was last approved by OMB on
December 2, 2010, its burden has decreased by 407,421 hours, from
408,775 to 1,354 reporting hours. This adjustment is a result of FDA
experience over the past 2 years in the regulation of tobacco products
and is based on the actual number of establishment registration and
product ingredient submissions received during this time period. In
2010, when this collection was first published for public comment in
the Federal Register, FDA attempted to determine the actual number of
tobacco manufacturers by using the Security and Exchange Commission's
Standard Industrial Classification (SIC) codes, which are identifying
codes that appear in a company's EDGAR filings to show the company's
type of business. When preparing the collection of information package
for publication in 2010, the tobacco industry codes indicated that over
10,000 tobacco manufacturers existed under the SIC codes for tobacco
products and cigarettes. However, upon further examination of these
codes, it appears that the number of tobacco manufacturers was greatly
inflated, as the SIC codes included tobacco retail in addition to
tobacco manufacturers. In addition, no comments were received from the
2010 initial 60-day Federal Register notice regarding either the number
of respondents or the number of reporting burden hours listed in the
notice, so FDA used the collection's SIC-researched manufacturer
numbers for this collection of information. Actual FDA registration and
product listing report submissions and FDA experience indicate in the
past 2 years, the number of tobacco manufacturers required to register
and list their products and ingredient listings is approximately 125, a
substantial decrease from the number of potential respondents listed in
2010. By applying the revised number of manufacturers to the burden
chart, the total burden for registration and listing now is currently
estimated to be 1,354 reporting burden hours, much less than the
408,775 OMB-approved reporting burden hours stated in 2010.
Based on the actual number of registration and product ingredient
listing reports received by FDA over the past 2 years, the number of
expected annual responses is projected to decrease from 100,000
registration responses to 200 annual responses, and from 11,000 annual
product ingredient listing responses to 200 annual product ingredient
responses. The Agency bases its estimate on the actual number of
registration and listing and product ingredient listing reports
received, its experience with the submission of registration and
listing requirements applicable to other FDA regulated products, and
ongoing interactions with industry. FDA estimates that the submission
of registration information as required by section 905 of the FD&C Act
will remain at 3.75 hours per establishment. Based on the actual number
of registration information submitted in the past 2 years and its
experience, the Agency estimates that approximately 200 registrations
will be submitted from 125 tobacco product establishments annually, for
a total 750 hour burden (125 respondents x 1.6 responses per respondent
x 3.75 hours per response).
FDA estimates that the submission of ingredient listing information
as required by section 904 of the FD&C Act will remain at 3.0 hours per
tobacco product. Based on the actual number of product ingredient
listings submitted over the past 2 years and its experience, the Agency
estimates that approximately 200 ingredient listings will be submitted
from 125 tobacco establishments, for a total 600 burden hours (125
respondents x 1.6 responses per respondent x 3.0 hours per response).
FDA estimates that obtaining a Dun and Bradstreet (DUNS) number
will take 0.5 hours, and that 8 respondents (1 percent (1.25) of
establishments required to register under section 905 and 5 percent
(6.25) of submitters required to list ingredients under section 904)
will not already have a DUNS number. The total burden, therefore, will
be 4 hours (8 respondents x 1 response per respondent x 0.5 hours per
response).
Total burden hours for this collection, therefore is 1,354 hours
(750 + 600 + 4 hours).
Dated: July 30, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18975 Filed 8-2-12; 8:45 am]
BILLING CODE 4160-01-P
