Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act, 57444-57445 [2019-23250]
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Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Total
operating and
maintenance
costs
Request for CLIA categorization ..............
80
5
400
1
400
$2,000
1 There
are no capital costs associated with this collection of information.
Based on recent receipt data for
requests for CLIA categorization
separate from a product application, the
number of respondents is approximately
80. On average, each respondent
requests such categorizations five times
per year.
The cost, not including personnel, is
estimated at $5 per submission (5 ×
400), totaling $2,000. This includes the
cost of copying and mailing copies of
package inserts and a cover letter. The
burden hours are based on FDA
familiarity with the types of
documentation typically included in a
sponsor’s categorization requests, and
costs for basic office supplies (e.g.,
paper). Upon review of this information
collection, we have adjusted the
estimated cost per submission
(previously $52). Because the
submissions are typically only a few
pages per package insert and copying or
printing and postage for a few pages is
not expected to be more than $5, we
believe this is a more appropriate cost
burden estimate.
Our estimated burden for the
information collection reflects an
overall decrease of 500 hours. We
attribute this adjustment to a decrease in
the number of submissions we received
over the last few years. Also, upon
review of this information collection,
we believe the previous estimate may
have included requests for
categorization associated with a
premarket submission, the burden
estimate of which is included under the
OMB approval for the applicable
premarket submission. We have
therefore revised the number of
respondents/responses to include only
those that are separate from a product
application, consistent with the scope of
this information collection.
Dated: October 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–23274 Filed 10–24–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0190]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Requirements
Under the Comprehensive Smokeless
Tobacco Health Education Act of 1986,
as Amended by the Family Smoking
Prevention and Tobacco Control Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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.
SUMMARY:
Fax written comments on the
collection of information by November
25, 2019.
DATES:
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 0910–0671. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Requirements Under the
Comprehensive Smokeless Tobacco
Health Education Act of 1986, as
Amended by the Family Smoking
Prevention and Tobacco Control Act
OMB Control Number 0910–0671—
Extension
The Family Smoking Prevention and
Tobacco Control Act (the Tobacco
Control Act) was enacted on June 22,
2009, amending the Federal Food, Drug,
and Cosmetic Act and providing FDA
with the authority to regulate tobacco
products (Pub. L. 111–31; 123 Stat.
1776). Section 3 of the Comprehensive
Smokeless Tobacco Health Education
Act of 1986 (the Smokeless Tobacco
Act) (15 U.S.C. 4402), as amended by
section 204 of the Tobacco Control Act,
requires, among other things, that all
smokeless tobacco product packages
and advertisements bear one of four
required warning statements. Section
3(b)(3)(A) of the Smokeless Tobacco Act
requires that the warnings be displayed
on packaging and advertising for each
brand of smokeless tobacco ‘‘in
accordance with a plan submitted by the
tobacco product manufacturer, importer,
distributor, or retailer’’ to, and approved
by, FDA.
This information collection-the
submission to FDA of warning plans for
smokeless tobacco products is
statutorily mandated. The warning
plans will be reviewed by FDA, as
required by the Smokeless Tobacco Act,
to determine whether the companies’
plans for the equal distribution and
display of warning statements on
packaging and the quarterly rotation of
warning statements in advertising for
each brand of smokeless tobacco
products comply with section 3 of the
Smokeless Tobacco Act, as amended.
Additionally, FDA considers a
submission to be a supplement if the
submitter is seeking approval of a
change to an FDA-approved warning
plan.
Based on FDA’s experience over the
past several years, FDA believes the
estimate of 60 hours to complete an
initial rotational plan continues to be
accurate. If a supplement to an
approved plan is submitted, FDA
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57445
Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices
estimates it will take half the time per
response (30 hours).
In the Federal Register of June 13,
2019 (84 FR 27638), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Numbers of
responses per
respondent
Numbers of
respondents
Activity
Average
burden per
response
Total annual
responses
Total hours
Total capital
costs
Submission of Initial rotational plans for
health warning statements ...................
Supplement to approved plan ..................
4
10
1
1
4
10
60
30
240
300
$48
120
Total ..................................................
........................
........................
........................
........................
540
168
1 There
are no operating and maintenance costs associated with this collection of information.
FDA estimates a total of 4 respondents
will submit a new original warning plan
and take 60 hours to complete a
rotational warning plan for a total of 240
burden hours. In addition, 10
respondents will submit a supplement
to an approved warning plan at 30 hours
per response for a total of 300 hours.
The total burden for this collection is
estimated to be 540 hours.
Capital costs are based on 14
respondents mailing in their submission
at a postage rate of $12 for a 5-pound
parcel (business parcel post mail
delivered from the furthest delivery
zone). Therefore, FDA estimates that the
total postage cost for mailing the
rotational warning plans to FDA to be
$168.
We have adjusted our burden
estimate, which has resulted in a
decrease of 5,460 hours and 86
respondents to the currently approved
burden. We received a total number of
44 original smokeless warning plans,
and a total of 17 supplements. After
receiving the initial influx of original
warnings plans, FDA does not expect to
receive as many original warning plans
annually. We expect that a few
supplements will continue to be
received as new products are marketed
or as warning plans are revised. We
anticipate a total number of 10
supplements submitted annually and 4
original smokeless warning plans.
Dated: October 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–23250 Filed 10–24–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2686]
Medical Devices; Exemptions From
Premarket Notification: Class II
Devices; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA or the Agency) is
announcing its intent to exempt a list of
class II devices from premarket
notification requirements, subject to
certain limitations. The Agency has
determined that, based on established
factors, these devices no longer require
premarket notification to provide
reasonable assurance of safety and
effectiveness. FDA is publishing this
notice to obtain comments regarding the
proposed exemptions, in accordance
with the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
DATES: Submit either electronic or
written comments on the notice by
December 24, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before December 24,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 24, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
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• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–2686 for ‘‘Medical Devices;
Exemptions from Premarket
Notification: Class II Devices; Request
for Comments.’’ Received comments,
those filed in a timely manner (see
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]]>Agencies
[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57444-57445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23250]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0190]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Requirements Under
the Comprehensive Smokeless Tobacco Health Education Act of 1986, as
Amended by the Family Smoking Prevention and Tobacco Control Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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
November 25, 2019.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0671.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
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.
Requirements Under the Comprehensive Smokeless Tobacco Health Education
Act of 1986, as Amended by the Family Smoking Prevention and Tobacco
Control Act
OMB Control Number 0910-0671--Extension
The Family Smoking Prevention and Tobacco Control Act (the Tobacco
Control Act) was enacted on June 22, 2009, amending the Federal Food,
Drug, and Cosmetic Act and providing FDA with the authority to regulate
tobacco products (Pub. L. 111-31; 123 Stat. 1776). Section 3 of the
Comprehensive Smokeless Tobacco Health Education Act of 1986 (the
Smokeless Tobacco Act) (15 U.S.C. 4402), as amended by section 204 of
the Tobacco Control Act, requires, among other things, that all
smokeless tobacco product packages and advertisements bear one of four
required warning statements. Section 3(b)(3)(A) of the Smokeless
Tobacco Act requires that the warnings be displayed on packaging and
advertising for each brand of smokeless tobacco ``in accordance with a
plan submitted by the tobacco product manufacturer, importer,
distributor, or retailer'' to, and approved by, FDA.
This information collection-the submission to FDA of warning plans
for smokeless tobacco products is statutorily mandated. The warning
plans will be reviewed by FDA, as required by the Smokeless Tobacco
Act, to determine whether the companies' plans for the equal
distribution and display of warning statements on packaging and the
quarterly rotation of warning statements in advertising for each brand
of smokeless tobacco products comply with section 3 of the Smokeless
Tobacco Act, as amended. Additionally, FDA considers a submission to be
a supplement if the submitter is seeking approval of a change to an
FDA-approved warning plan.
Based on FDA's experience over the past several years, FDA believes
the estimate of 60 hours to complete an initial rotational plan
continues to be accurate. If a supplement to an approved plan is
submitted, FDA
[[Page 57445]]
estimates it will take half the time per response (30 hours).
In the Federal Register of June 13, 2019 (84 FR 27638), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Numbers of Average
Activity Numbers of responses per Total annual burden per Total hours Total capital
respondents respondent responses response costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of Initial rotational plans for health 4 1 4 60 240 $48
warning statements.....................................
Supplement to approved plan............................. 10 1 10 30 300 120
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. 540 168
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
FDA estimates a total of 4 respondents will submit a new original
warning plan and take 60 hours to complete a rotational warning plan
for a total of 240 burden hours. In addition, 10 respondents will
submit a supplement to an approved warning plan at 30 hours per
response for a total of 300 hours. The total burden for this collection
is estimated to be 540 hours.
Capital costs are based on 14 respondents mailing in their
submission at a postage rate of $12 for a 5-pound parcel (business
parcel post mail delivered from the furthest delivery zone). Therefore,
FDA estimates that the total postage cost for mailing the rotational
warning plans to FDA to be $168.
We have adjusted our burden estimate, which has resulted in a
decrease of 5,460 hours and 86 respondents to the currently approved
burden. We received a total number of 44 original smokeless warning
plans, and a total of 17 supplements. After receiving the initial
influx of original warnings plans, FDA does not expect to receive as
many original warning plans annually. We expect that a few supplements
will continue to be received as new products are marketed or as warning
plans are revised. We anticipate a total number of 10 supplements
submitted annually and 4 original smokeless warning plans.
Dated: October 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23250 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P
