Agency Information Collection Activities; Proposed Collection; Comment Request; Potential Tobacco Product Violations Reporting Form, 9216-9217 [2014-03381]

Download as PDF 9216 Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0086] Agency Information Collection Activities; Proposed Collection; Comment Request; Potential Tobacco Product Violations Reporting Form 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 the collection of information contained in FDA’s Tobacco Product Violations Reporting Form. DATES: Submit either electronic or written comments on the collection of information by April 21, 2014. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 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, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 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 tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 20:58 Feb 14, 2014 Jkt 232001 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. Potential Tobacco Product Violations Reporting Form—(OMB Control Number 0910–0716)—Extension On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 111–31) into law. The Tobacco Control Act amended section 201 et seq. of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321 et seq.) by adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. FDA is requesting an extension of OMB approval for the collection of PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 information to accept consumer and other stakeholder feedback and notification of potential violations of the FD&C Act, as amended by the Tobacco Control Act. FDA created a Tobacco Call Center (with a toll-free number: 1–877–CTP– 1373). Callers are able to report potential violations of the Tobacco Control Act, and FDA will conduct targeted followup investigations based on information received. When callers report a violation, the caller will be asked to provide as much certain information as they can recall, including: The date the potential violation occurred; product type (e.g., cigarette, smokeless, roll-your-own); tobacco brand; potential violation type; type of potentially violative promotional materials; who potentially violated; and the name, address, phone number, and email address of the potential violator. The caller will also be asked to list the potential violator’s Web site (if available), describe the potential violation, and provide any additional files or information pertinent to the potential violation. FDA currently provides a form that may be used to solicit this information from the caller (Form FDA 3779, Potential Tobacco Product Violations Report), and seeks renewal of Form FDA 3779. This form is posted on FDA’s Web site. The public and interested stakeholders are also able to report information regarding possible violations of the Tobacco Control Act through the following methods: Calling the Tobacco Call Center using the Center for Tobacco Products’ (CTP) tollfree number; using a fillable Form FDA 3779 found on FDA’s Web site; downloading a PDF version of the form to send via email or mail to FDA; requesting a copy of Form FDA 3779 by contacting CTP and sending by mail to FDA; and sending a letter to FDA’s CTP. The public and interested stakeholders will also be able to report information regarding possible violations of the Tobacco Control Act in the future using FDA’s tobacco violation reporting smartphone application. FDA estimates the burden of this collection of information as follows: E:\FR\FM\18FEN1.SGM 18FEN1 9217 Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Reporting violations of the FD&C Act, as amended by the Tobacco Control Act, by telephone, Internet form, mail, smartphone application, or email.. 1 There 400 Total annual responses 2 800 Average burden per response Total hours 0.25 (15 minutes) ............................. 200 are no capital costs or operating and maintenance costs associated with this collection of information. FDA estimates that submitting the information (by telephone, Internet, mail, smartphone application, or email) will take 0.25 hours (i.e., 15 minutes) per response. FDA estimates the number of annual respondents to this collection of information will be 400, who will each submit 2 reports by telephone, Internet, mail, smartphone application, or email. This estimate is based on the rate of reporting through Form FDA 3779, reports received from FDA’s tollfree telephone number and email address, and FDA experience. Each report is expected to take 0.25 hours to complete and submit; therefore, total burden hours for this collection of information is estimated to be 200 hours (800 responses x 0.25 hours per response). The total burden hours for this collection have decreased by 50 hours (from 250 to 200) because the number of estimated respondents decreased from 1,000 to 400, and the annual responses are expected to drop from 1,000 to 800 annually. Based on past submissions to FDA, the number of estimated annual respondents is expected to decrease from 1,000 to 400 and each respondent’s number of submissions is expected to increase from 1 to 2 annually. Therefore, the number of responses are expected to decrease from 1,000 to 800 annually (400 respondents x 2 responses). Dated: February 10, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–03381 Filed 2–14–14; 8:45 am] BILLING CODE 4160–01–P tkelley on DSK3SPTVN1PROD with NOTICES No. of Responses per respondent No. of Respondents Activity and Form FDA 3779 DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2014–N–0168] [Docket No. FDA–2013–N–0823] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Over-the-Counter Human Drugs; Labeling Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ACTION: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Over-the-Counter Human Drugs; Labeling Requirements’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On December 20, 2013; the Agency submitted a proposed collection of information entitled ‘‘Over-the-Counter Human Drugs; Labeling Requirements’’ 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 0910–0340. The approval expires on January 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUMMARY: [FR Doc. 2014–03348 Filed 2–14–14; 8:45 am] BILLING CODE 4160–01–P 20:58 Feb 14, 2014 Jkt 232001 PO 00000 Frm 00061 Fmt 4703 AGENCY: Food and Drug Administration, HHS. Dated: February 10, 2014. Leslie Kux, Assistant Commissioner for Policy. VerDate Mar<15>2010 Agency Information Collection Activities; Proposed Collection; Comment Request; Disclosure Regarding Additional Risks in Directto-Consumer Prescription Drug Television Advertisements Sfmt 4703 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ‘‘Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television (TV) Advertisements (Ads).’’ This study will investigate the impact of limiting the risks presented in DTC prescription drug television ads to those that are serious and actionable, and including a disclosure to alert consumers that there are other product risks not disclosed in the ad. DATES: Submit either electronic or written comments on the collection of information by April 21, 2014. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. SUMMARY: E:\FR\FM\18FEN1.SGM 18FEN1

Agencies

[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9216-9217]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03381]



[[Page 9216]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0086]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Potential Tobacco Product Violations Reporting Form

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 the collection of information 
contained in FDA's Tobacco Product Violations Reporting Form.

DATES: Submit either electronic or written comments on the collection 
of information by April 21, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to https://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, 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.

Potential Tobacco Product Violations Reporting Form--(OMB Control 
Number 0910-0716)--Extension

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 
111-31) into law. The Tobacco Control Act amended section 201 et seq. 
of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
321 et seq.) by adding a new chapter granting FDA important new 
authority to regulate the manufacture, marketing, and distribution of 
tobacco products to protect the public health generally and to reduce 
tobacco use by minors. FDA is requesting an extension of OMB approval 
for the collection of information to accept consumer and other 
stakeholder feedback and notification of potential violations of the 
FD&C Act, as amended by the Tobacco Control Act.
    FDA created a Tobacco Call Center (with a toll-free number: 1-877-
CTP-1373). Callers are able to report potential violations of the 
Tobacco Control Act, and FDA will conduct targeted followup 
investigations based on information received. When callers report a 
violation, the caller will be asked to provide as much certain 
information as they can recall, including: The date the potential 
violation occurred; product type (e.g., cigarette, smokeless, roll-
your-own); tobacco brand; potential violation type; type of potentially 
violative promotional materials; who potentially violated; and the 
name, address, phone number, and email address of the potential 
violator. The caller will also be asked to list the potential 
violator's Web site (if available), describe the potential violation, 
and provide any additional files or information pertinent to the 
potential violation.
    FDA currently provides a form that may be used to solicit this 
information from the caller (Form FDA 3779, Potential Tobacco Product 
Violations Report), and seeks renewal of Form FDA 3779. This form is 
posted on FDA's Web site. The public and interested stakeholders are 
also able to report information regarding possible violations of the 
Tobacco Control Act through the following methods: Calling the Tobacco 
Call Center using the Center for Tobacco Products' (CTP) toll-free 
number; using a fillable Form FDA 3779 found on FDA's Web site; 
downloading a PDF version of the form to send via email or mail to FDA; 
requesting a copy of Form FDA 3779 by contacting CTP and sending by 
mail to FDA; and sending a letter to FDA's CTP. The public and 
interested stakeholders will also be able to report information 
regarding possible violations of the Tobacco Control Act in the future 
using FDA's tobacco violation reporting smartphone application.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 9217]]



                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    No. of
  Activity and Form FDA 3779        No. of       Responses per   Total annual    Average burden     Total hours
                                  Respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Reporting violations of the                400               2             800  0.25 (15                     200
 FD&C Act, as amended by the                                                     minutes).
 Tobacco Control Act, by
 telephone, Internet form,
 mail, smartphone application,
 or email..
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that submitting the information (by telephone, 
Internet, mail, smartphone application, or email) will take 0.25 hours 
(i.e., 15 minutes) per response. FDA estimates the number of annual 
respondents to this collection of information will be 400, who will 
each submit 2 reports by telephone, Internet, mail, smartphone 
application, or email. This estimate is based on the rate of reporting 
through Form FDA 3779, reports received from FDA's toll-free telephone 
number and email address, and FDA experience. Each report is expected 
to take 0.25 hours to complete and submit; therefore, total burden 
hours for this collection of information is estimated to be 200 hours 
(800 responses x 0.25 hours per response). The total burden hours for 
this collection have decreased by 50 hours (from 250 to 200) because 
the number of estimated respondents decreased from 1,000 to 400, and 
the annual responses are expected to drop from 1,000 to 800 annually. 
Based on past submissions to FDA, the number of estimated annual 
respondents is expected to decrease from 1,000 to 400 and each 
respondent's number of submissions is expected to increase from 1 to 2 
annually. Therefore, the number of responses are expected to decrease 
from 1,000 to 800 annually (400 respondents x 2 responses).

    Dated: February 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03381 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-01-P
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