81 FR 48813 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 143 (July 26, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 143 (July 26, 2016)
| Page Range | 48813-48814 | |
| FR Document | 2016-17569 |
[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)] [Notices] [Pages 48813-48814] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17569] ----------------------------------------------------------------------- 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) 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 August 25, 2016. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0671. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. 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. Based on the Federal Trade Commission's (FTC's) previous experience with the submission of warning plans and FDA's experience, FDA estimates that there are 52 companies affected by this information collection. To account for the entry of new smokeless tobacco companies that may be affected by this information collection, FDA is conservatively estimating the total number of annual respondents to this collection of information to be 100. When the FTC requested an extension of their approved warning plan information collection in 2007, based on over 20 years implementing the warning plan requirements and taking into account increased computerization and improvements in electronic communication, the FTC estimated submitting an initial plan would take 60 hours. 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 reasonable. FDA estimates the burden of this collection of information as follows: [[Page 48814]] Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Numbers of Activity Numbers of responses per Total annual Average burden Total hours Total capital respondents respondent responses per response costs -------------------------------------------------------------------------------------------------------------------------------------------------------- Submission of rotational plans for health warning 100 1 100 60 6,000 $1,200 statements........................................ -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no operating and maintenance costs associated with this collection of information. FDA estimates a total of 100 respondents will respond to this collection of information and take 60 hours to complete a rotational warning plan for a total of 6,000 burden hours. In addition, capital costs are based on 100 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 $1,200. In the Federal Register of February, 19, 2016 (81 FR 8505), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was PRA related comment was received. (Comment) The comment believes that warning plans should not be renewed every year, but should remain in force as long as necessary after their approval (Response) FDA does not require that a previously FDA-approved warning plan be resubmitted. FDA reviews and approves warning plans only once, unless a submitter seeks to change the distribution or display of warnings on packages or rotation of warnings in advertisements, in which case the submission would be considered a supplement. The purpose of FDA's proposed extension is to account for the entry of new smokeless tobacco product brands and advertising onto the market place. Dated: July 20, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-17569 Filed 7-25-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices 48813
such recommendations should contain, DEPARTMENT OF HEALTH AND 2009, amending the Federal Food, Drug,
at a minimum, the following HUMAN SERVICES and Cosmetic Act and providing FDA
information: (1) Title of the standard, (2) with the authority to regulate tobacco
any reference number and date, (3) Food and Drug Administration products (Pub. L. 111–31; 123 Stat.
name and address of the national or [Docket No. FDA–2013–N–0190] 1776). Section 3 of the Comprehensive
international standards development Smokeless Tobacco Health Education
organization, (4) a proposed list of Agency Information Collection Act of 1986 (the Smokeless Tobacco
devices for which a declaration of Activities; Submission for Office of Act) (15 U.S.C. 4402), as amended by
conformity to this standard should Management and Budget Review; section 204 of the Tobacco Control Act,
routinely apply, and (5) a brief Comment Request; Requirements requires, among other things, that all
identification of the testing or Under the Comprehensive Smokeless smokeless tobacco product packages
performance or other characteristics of Tobacco Health Education Act of 1986, and advertisements bear one of four
as Amended by the Family Smoking required warning statements. Section
the device(s) that would be addressed
Prevention and Tobacco Control Act 3(b)(3)(A) of the Smokeless Tobacco Act
by a declaration of conformity.
requires that the warnings be displayed
VI. Electronic Access AGENCY: Food and Drug Administration, on packaging and advertising for each
HHS. brand of smokeless tobacco ‘‘in
You may obtain a copy of ‘‘Guidance ACTION: Notice. accordance with a plan submitted by the
on the Recognition and Use of tobacco product manufacturer, importer,
Consensus Standards’’ by using the SUMMARY: The Food and Drug
distributor, or retailer’’ to, and approved
Administration (FDA) is announcing
Internet. The Center for Devices and by, FDA.
that a proposed collection of
Radiological Health (CDRH) maintains a This information collection-the
information has been submitted to the
site on the Internet for easy access to submission to FDA of warning plans for
Office of Management and Budget
information including text, graphics, smokeless tobacco products is
(OMB) for review and clearance under
and files that you may download to a statutorily mandated. The warning
the Paperwork Reduction Act of 1995.
personal computer with access to the plans will be reviewed by FDA, as
DATES: Fax written comments on the
Internet. Updated on a regular basis, the required by the Smokeless Tobacco Act,
collection of information by August 25, to determine whether the companies’
CDRH home page, http://www.fda.gov/ 2016.
MedicalDevices, includes a link to plans for the equal distribution and
ADDRESSES: To ensure that comments on display of warning statements on
standards-related documents including the information collection are received,
the guidance and the current list of packaging and the quarterly rotation of
OMB recommends that written warning statements in advertising for
recognized standards. After publication comments be faxed to the Office of
in the Federal Register, this notice each brand of smokeless tobacco
Information and Regulatory Affairs, products comply with section 3 of the
announcing ‘‘Modification to the List of OMB, Attn: FDA Desk Officer, FAX: Smokeless Tobacco Act, as amended.
Recognized Standards, Recognition List 202–395–7285, or emailed to oira_ Based on the Federal Trade
Number: 044’’ will be available at http:// submission@omb.eop.gov. All Commission’s (FTC’s) previous
www.fda.gov/MedicalDevices/ comments should be identified with the experience with the submission of
DeviceRegulationandGuidance/ OMB control number 0910–0671. Also warning plans and FDA’s experience,
Standards/ucm123792.htm. You may include the FDA docket number found FDA estimates that there are 52
access ‘‘Guidance on the Recognition in brackets in the heading of this companies affected by this information
and Use of Consensus Standards,’’ and document. collection. To account for the entry of
the searchable database for ‘‘FDA FOR FURTHER INFORMATION CONTACT: FDA new smokeless tobacco companies that
Recognized Consensus Standards’’ at PRA Staff, Office of Operations, Food may be affected by this information
http://www.fda.gov/MedicalDevices/ and Drug Administration, Three White collection, FDA is conservatively
DeviceRegulationandGuidance/ Flint North, 10A63, 11601 Landsdown estimating the total number of annual
Standards. St., North Bethesda, MD 20852, respondents to this collection of
Dated: July 19, 2016. PRAStaff@fda.hhs.gov. information to be 100.
Leslie Kux, SUPPLEMENTARY INFORMATION: In When the FTC requested an extension
compliance with 44 U.S.C. 3507, FDA of their approved warning plan
Associate Commissioner for Policy. information collection in 2007, based on
has submitted the following proposed
[FR Doc. 2016–17570 Filed 7–25–16; 8:45 am] over 20 years implementing the warning
collection of information to OMB for
BILLING CODE 4164–01–P review and clearance. plan requirements and taking into
account increased computerization and
Requirements Under the improvements in electronic
Comprehensive Smokeless Tobacco communication, the FTC estimated
Health Education Act of 1986, as submitting an initial plan would take 60
Amended by the Family Smoking hours. Based on FDA’s experience over
Prevention and Tobacco Control Act the past several years, FDA believes the
(OMB Control Number 0910–0671)— estimate of 60 hours to complete an
Extension initial rotational plan continues to be
srobinson on DSK5SPTVN1PROD with NOTICES
The Family Smoking Prevention and reasonable.
Tobacco Control Act (the Tobacco FDA estimates the burden of this
Control Act) was enacted on June 22, collection of information as follows:
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![48814 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Numbers of Average bur-
Numbers of Total annual Total capital
Activity responses per den per Total hours
respondents responses costs
respondent response
Submission of rotational plans for health
warning statements .............................. 100 1 100 60 6,000 $1,200
1 There are no operating and maintenance costs associated with this collection of information.
FDA estimates a total of 100 DEPARTMENT OF HEALTH AND comment will be made public, you are
respondents will respond to this HUMAN SERVICES solely responsible for ensuring that your
collection of information and take 60 comment does not include any
hours to complete a rotational warning Food and Drug Administration confidential information that you or a
plan for a total of 6,000 burden hours. [Docket No. FDA–2016–D–1853] third party may not wish to be posted,
In addition, capital costs are based on such as medical information, your or
100 respondents mailing in their Unique Device Identification System: anyone else’s Social Security number, or
submission at a postage rate of $12 for Form and Content of the Unique confidential business information, such
a 5-pound parcel (business parcel post Device Identifier; Draft Guidance for as a manufacturing process. Please note
mail delivered from the furthest Industry and Food and Drug that if you include your name, contact
delivery zone). Therefore, FDA Administration Staff; Availability and information, or other information that
estimates that the total postage cost for Request for Comments identifies you in the body of your
comments, that information will be
mailing the rotational warning plans to AGENCY: Food and Drug Administration, posted on http://www.regulations.gov.
FDA to be $1,200. HHS. • If you want to submit a comment
In the Federal Register of February, ACTION:Notice of availability; request with confidential information that you
19, 2016 (81 FR 8505), FDA published for comments. do not wish to be made available to the
a 60-day notice requesting public public, submit the comment as a
comment on the proposed collection of SUMMARY: The Food and Drug written/paper submission and in the
information. One comment was PRA Administration (FDA) is announcing the manner detailed (see ‘‘Written/Paper
availability of the draft guidance for Submissions’’ and ‘‘Instructions’’).
related comment was received.
industry and FDA staff entitled ‘‘Unique
(Comment) The comment believes Device Identification System: Form and Written/Paper Submissions
that warning plans should not be Content of the Unique Device Identifier Submit written/paper submissions as
renewed every year, but should remain (UDI).’’ When finalized, this draft follows:
in force as long as necessary after their document will define the expected • Mail/Hand delivery/Courier (for
approval content and forms of the unique device written/paper submissions): Division of
(Response) FDA does not require that identifier (UDI), to assist both labelers Dockets Management (HFA–305), Food
a previously FDA-approved warning and FDA-accredited issuing agencies and Drug Administration, 5630 Fishers
plan be resubmitted. FDA reviews and better ensure the UDIs developed under Lane, rm. 1061, Rockville, MD 20852.
approves warning plans only once, systems for the issuance of UDIs are in • For written/paper comments
unless a submitter seeks to change the compliance with the unique device submitted to the Division of Dockets
identification system rule (UDI Rule). Management, FDA will post your
distribution or display of warnings on
This draft guidance is not the final comment, as well as any attachments,
packages or rotation of warnings in
version of the guidance nor is it in effect except for information submitted,
advertisements, in which case the at this time.
submission would be considered a marked and identified, as confidential,
DATES: Although you can comment on if submitted as detailed in
supplement. The purpose of FDA’s
any guidance at any time (see 21 CFR ‘‘Instructions.’’
proposed extension is to account for the
10.115(g)(5)), to ensure that the Agency Instructions: All submissions received
entry of new smokeless tobacco product
considers your comment of this draft must include the Docket No. FDA–
brands and advertising onto the market guidance before it begins work on the 2016–D–1853 for ‘‘Unique Device
place. final version of the guidance, submit Identification System: Form and
Dated: July 20, 2016. either electronic or written comments Content of the Unique Device Identifier
Leslie Kux, on the draft guidance by September 26, (UDI).’’ Received comments will be
Associate Commissioner for Policy. 2016. placed in the docket and, except for
[FR Doc. 2016–17569 Filed 7–25–16; 8:45 am] ADDRESSES: You may submit comments those submitted as ‘‘Confidential
as follows: Submissions,’’ publicly viewable at
BILLING CODE 4164–01–P
http://www.regulations.gov or at the
Electronic Submissions Division of Dockets Management
Submit electronic comments in the between 9 a.m. and 4 p.m., Monday
following way: through Friday.
srobinson on DSK5SPTVN1PROD with NOTICES
• Federal eRulemaking Portal: http:// • Confidential Submissions—To
www.regulations.gov. Follow the submit a comment with confidential
instructions for submitting comments. information that you do not wish to be
Comments submitted electronically, made publicly available, submit your
including attachments, to http:// comments only as a written/paper
www.regulations.gov will be posted to submission. You should submit two
the docket unchanged. Because your copies total. One copy will include the
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Document Created: 2018-02-08 08:00:27
Document Modified: 2018-02-08 08:00:27
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by August 25, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 48813 |
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