Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act, 8505-8507 [2016-03478]

Download as PDF asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices viruses in the manufacturing process for such plasma-derived products. ZIKV is an arbovirus from the Flaviviridae family, genus Flavivirus. It is transmitted to humans primarily by the Aedes aegypti mosquito, but it may also be transmitted by the Aedes albopictus mosquito. In addition, intrauterine, perinatal, and sexual transmission of ZIKV has been reported. Two instances of possible transfusiontransmission of ZIKV in Brazil have been described in media announcements. The most common ZIKV disease symptoms include fever, arthralgia, maculopapular rash, and conjunctivitis. Neurological manifestations and congenital anomalies have been associated with ZIKV disease outbreaks. Association of ZIKV infection with ´ Guillain-Barre syndrome cases has been reported during outbreaks in Polynesia and in Brazil. In Brazil there has also been a marked increase in the incidence of microcephaly in regions most affected by the ZIKV epidemic. ZIKV reached the Americas in early 2015 with local transmission first reported in Brazil and as of February 10, 2016, there are 30 countries and territories worldwide with active local transmission of the virus. As of February 10, 2016, local mosquito-borne transmission of ZIKV has not been reported in the continental United States, but cases have been reported in travelers returning to the United States from areas with local transmission. Consistent with existing regulations and applicable guidance, donors must be in good health at the time of donation § 640.3(b) (21 CFR 640.3(b)) as indicated by, among other things, freedom from any disease transmissible by blood transfusion, as can be determined by history and examination (§ 640.3(b)(6)). Standard operating procedures that are already in place should result in the deferral of individuals who have symptoms consistent with ZIKV infection at the time of donation. The recommendations in the guidance are intended to reduce the risk of collecting blood and blood components from atrisk donors who could be potentially infected with ZIKV and do not display clinical symptoms during the incubation period or have an asymptomatic infection. The guidance recommends that blood collection establishments in areas without active transmission of ZIKV defer donors at risk for ZIKV infection as follows: Defer for 4 weeks after the resolution of symptoms a donor with a history of ZIKV infection or a donor who reports symptoms suggestive of ZIKV within 2 weeks of departure from VerDate Sep<11>2014 17:59 Feb 18, 2016 Jkt 238001 an area with active transmission of ZIKV; defer for 4 weeks after the last sexual contact a donor who has had sexual contact with a man who has been diagnosed with ZIKV or who traveled to or resided in an area with active transmission of ZIKV in the 3 months prior to that instance of sexual contact; and defer for 4 weeks from the date of his or her departure, a donor who has been a resident of or has travelled to an area with active transmission of ZIKV. For areas with active transmission of ZIKV, the guidance recommends that blood collection establishments obtain blood and blood components from areas of the United States without active transmission of ZIKV to fulfill orders. However, a blood establishment may collect platelets and plasma locally if the blood establishment implements FDA-approved pathogen reduction technology for platelets and plasma. Further, blood establishments in areas of active transmission may collect blood components locally provided the establishment tests blood donations with an FDA-licensed blood donor screening test for ZIKV, when such a test becomes available. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2) without initially seeking prior comment because the Agency has determined that prior public participation is not feasible or appropriate. The guidance represents the current thinking of FDA on ‘‘Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR 601.12 have been approved under OMB control number 0910–0338; and the collections of information in 21 CFR 606.100(b), 606.160(b)(1), and 640.3(a) have been approved under OMB control number 0910–0116. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 8505 III. Electronic Access Persons with access to the Internet may obtain the guidance at either https://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Dated: February 12, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–03393 Filed 2–18–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0190] Agency Information Collection Activities; Proposed Collection; 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) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on submission of rotational plans for health warning label statements for smokeless tobacco products. DATES: Submit either electronic or written comments on the collection of information by April 19, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • 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 E:\FR\FM\19FEN1.SGM 19FEN1 8506 Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES 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): 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– 2013–N–0190 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://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 information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION’’. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information VerDate Sep<11>2014 17:59 Feb 18, 2016 Jkt 238001 redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. 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 (FD&C 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 E:\FR\FM\19FEN1.SGM 19FEN1 Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices 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 8507 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: 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 Total capital costs 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 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. Dated: February 12, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–03478 Filed 2–18–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0429 (formerly Docket No. 2007D–0496)] asabaliauskas on DSK5VPTVN1PROD with NOTICES Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing SUMMARY: VerDate Sep<11>2014 17:59 Feb 18, 2016 Jkt 238001 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 (the PRA). DATES: Fax written comments on the collection of information by March 21, 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 title. 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, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, 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: Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; OMB Control Number 0910–0641—Extension Section 502(x) of the FD&C Act (21 U.S.C. 352(x)), which was added by the Dietary Supplement and Nonprescription Drug Consumer PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 Protection Act (Pub. L. 109–462), requires the label of a nonprescription drug product marketed without an approved application in the United States to include a domestic address or domestic telephone number through which a manufacturer, packer, and distributor may receive a report of a serious adverse event associated with the product. The guidance document contains questions and answers relating to this labeling requirement and provides guidance to industry on the following topics: (1) The meaning of ‘‘domestic address’’ for purposes of the labeling requirements of section 502(x) of the FD&C Act; (2) FDA’s recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label under section 502(x) of the FD&C Act; and (3) FDA’s intent regarding enforcing the labeling requirements of section 502(x) of the FD&C Act. Description of Respondents: Respondents to this collection of information are manufacturers, packers, and distributors whose name (issued in section 502(b)(1) of the FD&C Act) appears on the label of a nonprescription drug product marketed in the United States without an approved application. In the Federal Register of July 17, 2015 (80 FR 42502), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment. However, these comments did not address the information collection. FDA estimates the burden of this collection of information as follows: E:\FR\FM\19FEN1.SGM 19FEN1

Agencies

[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8505-8507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03478]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0190]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on submission of rotational plans 
for health warning label statements for smokeless tobacco products.

DATES: Submit either electronic or written comments on the collection 
of information by April 19, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     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

[[Page 8506]]

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): 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-2013-N-0190 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Requirements Under the 
Comprehensive Smokeless Tobacco Health Education Act of 1986, as 
Amended by the Family Smoking Prevention and Tobacco Control Act.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://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 information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 (FD&C 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

[[Page 8507]]

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:

                                                     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.

    Dated: February 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03478 Filed 2-18-16; 8:45 am]
 BILLING CODE 4164-01-P

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