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, 48813-48814 [2016-17569]

Download as PDF Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. 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: VI. Electronic Access Food and Drug Administration, HHS. You may obtain a copy of ‘‘Guidance on the Recognition and Use of Consensus Standards’’ by using the Internet. The Center for Devices and Radiological Health (CDRH) maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page, http://www.fda.gov/ MedicalDevices, includes a link to standards-related documents including the guidance and the current list of recognized standards. After publication in the Federal Register, this notice announcing ‘‘Modification to the List of Recognized Standards, Recognition List Number: 044’’ will be available at http:// www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Standards/ucm123792.htm. You may access ‘‘Guidance on the Recognition and Use of Consensus Standards,’’ and the searchable database for ‘‘FDA Recognized Consensus Standards’’ at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Standards. Dated: July 19, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–17570 Filed 7–25–16; 8:45 am] BILLING CODE 4164–01–P srobinson on DSK5SPTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES 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 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. SUMMARY: 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, VerDate Sep<11>2014 20:28 Jul 25, 2016 Jkt 238001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 48813 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: E:\FR\FM\26JYN1.SGM 26JYN1 48814 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity Numbers of respondents Numbers of responses per respondent Total annual responses Average burden per response Total hours Submission of rotational plans for health warning statements .............................. 100 1 100 60 6,000 1 There $1,200 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–1853] Unique Device Identification System: Form and Content of the Unique Device Identifier; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of availability; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA staff entitled ‘‘Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).’’ When finalized, this draft document will define the expected content and forms of the unique device identifier (UDI), to assist both labelers and FDA-accredited issuing agencies better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with the unique device identification system rule (UDI Rule). This draft guidance is not the final version of the guidance nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 26, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions srobinson on DSK5SPTVN1PROD with NOTICES Total capital costs Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your VerDate Sep<11>2014 20:28 Jul 25, 2016 Jkt 238001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 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 http://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): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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– 2016–D–1853 for ‘‘Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the E:\FR\FM\26JYN1.SGM 26JYN1

Agencies

[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Notices]
[Pages 48813-48814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17569]


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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.

-----------------------------------------------------------------------

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