82 FR 28492 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 119 (June 22, 2017)

Page Range		28492-28493
FR Document		2017-13018

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.

Federal Register, Volume 82 Issue 119 (Thursday, June 22, 2017)

[Federal Register Volume 82, Number 119 (Thursday, June 22, 2017)]
[Notices]
[Pages 28492-28493]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-13018]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 July 
24, 2017.

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 0910-0716. 
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, 10A63, 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.

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

[[Page 28493]]

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 may conduct 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, cigar, e-cigarette, 
hookah, pipe tobacco); 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.
    In the Federal Register of November 7, 2016 (81 FR 78166), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Number of
       Activity and FDA Form 3779            Number of      responses per     Total annual          Average burden  per response           Total hours
                                            respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting violations of the FD&C Act, as             750                2            1,500   0.25 (15 minutes).........................             375
 amended by the Tobacco Control Act via
 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 form, paper form by mail, or email) will take 0.25 hour (i.e., 
15 minutes) per response. Based on the type and rate of reporting that 
has been submitted through the Potential Tobacco Violation Reporting 
Form in the past, in addition to the increase that FDA has recently 
experienced in the rate of reporting due to the recent rule, ``Deeming 
Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic 
Act, as Amended by the Family Smoking Prevention and Tobacco Control 
Act,'' FDA estimates the number of annual respondents to this 
collection of information will be 750, who will each submit 2 reports 
by telephone, Internet form, paper form, or email. Each report is 
expected to take 0.25 hour to complete and submit; therefore, total 
burden hours for this collection of information is estimated to be 375 
hours (1,500 responses x 0.25 hour per response).

    Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13018 Filed 6-21-17; 8:45 am]
BILLING CODE 4164-01-P

28492 Federal Register / Vol. 82, No. 119 / Thursday, June 22, 2017 / Notices

Comments in Response to the 60 Day because they were: (a) Programmatic in Burden Estimates
Federal Register Notice nature and not survey-related; (b)
referencing other data collections and Descriptions of previous National
A 60-Day notice was published in the not the NSOAAP (e.g., Census); or (c) Surveys of OAA Participants can be
Federal Register in Vol. 82, No. 13457 commentary without reference to the found under the section on OAA
on March 13, 2017. A Notice of NSOAAP. The majority of the comments Performance Information on ACL’s Web
Correction was published in the Federal that ACL received expressed the need to site at: https://www.acl.gov/programs/
Register in Vol. 82, No. 15062 on March retain demographic questions on sexual oaa-performance-information. Copies of
24, 2017, announcing that ACL was orientation/gender identity. In addition, the survey instruments and data from
requesting approval of a proposed comments addressed: (a) previous National Surveys of OAA
extension with modifications of a Methodological, survey design, and Participants can be found and queried
currently approved data collection. A sampling considerations; (b) concern using the AGing Integrated Database
second Notice of Correction was about the survey length; and (c) (AGID) at https://agid.acl.gov/. The
published in the Federal Register in recommendations to modify and/or add proposed National Survey entitled
Vol. 82, No. 20896 on May 4, 2017, clarifying questions throughout the
announcing that the web location of the National Survey of Older Americans Act
survey. ACL has made minor changes to Participants 2017 Revised may be found
proposed information collection would the survey based on some suggested
change due to an update of the ACL.gov on the ACL Web site at: https://
changes, including retaining the
Web site. www.acl.gov/about-acl/public-input.
primary question regarding sexual
The revisions, including the
ACL received comments from eighty- orientation. This survey has remained
nine (89) organizations and just over essentially the same since the last OMB reinstatement of the primary question
13,900 individuals about the National approval on 7/17/2014 (OMB Control on sexual orientation, represent minor
Survey of Older Americans Act Number 0985–0023), and the sampling changes in terms of data collection
Participants (NSOAAP). ACL reviewed methodology and the data collection burden that do not change the overall
all of the comments. Eight (8) of the procedures are identical to the previous estimated burden on respondents.
comments were deemed not relevant survey approved in 2014.

ANNUAL BURDEN ESTIMATES
Responses
Number of Hours per Annual burden
Respondent/data collection activity per
respondents response hours
respondent

Area Agency on Aging: Respondent selection process ...................... 250 1 4.0 ............................. 1,000
Service Recipients (i.e., Congregate and Home-delivered meal nutri- 4,000 1 .6667 ......................... 2,666.80
tion programs; Case Management, Homemaker, and Transpor-
tation Services).
National Family Caregiver Support Program Clients .......................... 2,000 1 .6667 ......................... 1,333.40

Total .............................................................................................. 6,250 1 .80 (weighted mean) 5,000

Estimated Total Annual Burden that a proposed collection of 20852, 301–796–8867, PRAStaff@
Hours: 5,000. information has been submitted to the fda.hhs.gov.
Dated: June 16, 2017. Office of Management and Budget
(OMB) for review and clearance under SUPPLEMENTARY INFORMATION: In
Daniel P. Berger, compliance with 44 U.S.C. 3507, FDA
the Paperwork Reduction Act of 1995.
Acting Administrator and Assistant Secretary has submitted the following proposed
for Aging. DATES: Fax written comments on the collection of information to OMB for
[FR Doc. 2017–13030 Filed 6–21–17; 8:45 am] collection of information by July 24, review and clearance.
BILLING CODE 4154–01–P 2017.
Potential Tobacco Product Violations
ADDRESSES: To ensure that comments on Reporting Form OMB Control Number
DEPARTMENT OF HEALTH AND the information collection are received, 0910–0716—Extension
HUMAN SERVICES OMB recommends that written
comments be faxed to the Office of On June 22, 2009, the President
Information and Regulatory Affairs, signed the Family Smoking Prevention
Food and Drug Administration
OMB, Attn: FDA Desk Officer, FAX: and Tobacco Control Act (the Tobacco
[Docket No. FDA–2014–N–0086]
202–395–7285, or emailed to oira_ Control Act) (Pub. L. 111–31) into law.
submission@omb.eop.gov. All The Tobacco Control Act amended
Agency Information Collection section 201 et seq. of the Federal Food,
Activities; Submission for Office of comments should be identified with the
OMB control number 0910–0716. Also Drug, and Cosmetic Act (the FD&C Act)
Management and Budget Review; (21 U.S.C. 321 et seq.) by adding a new
Comment Request; Potential Tobacco include the FDA docket number found
chapter granting FDA important new
sradovich on DSK3GMQ082PROD with NOTICES

Product Violations Reporting Form in brackets in the heading of this
document. authority to regulate the manufacture,
AGENCY: Food and Drug Administration, marketing, and distribution of tobacco
HHS. FOR FURTHER INFORMATION CONTACT: products to protect the public health
ACTION: Notice. Amber Sanford, Office of Operations, generally and to reduce tobacco use by
Food and Drug Administration, Three minors. FDA is requesting an extension
SUMMARY: The Food and Drug White Flint North, 10A63, 11601 of OMB approval for the collection of
Administration (FDA) is announcing Landsdown St., North Bethesda, MD information to accept consumer and

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Document Created: 2017-06-21 23:55:21
Document Modified: 2017-06-21 23:55:21

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 July 24, 2017.
Contact		Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]
FR Citation		82 FR 28492

82 FR 28492 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 119 (June 22, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration