Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form, 28492-28493 [2017-13018]
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28492
Federal Register / Vol. 82, No. 119 / Thursday, June 22, 2017 / Notices
Comments in Response to the 60 Day
Federal Register Notice
A 60-Day notice was published in the
Federal Register in Vol. 82, No. 13457
on March 13, 2017. A Notice of
Correction was published in the Federal
Register in Vol. 82, No. 15062 on March
24, 2017, announcing that ACL was
requesting approval of a proposed
extension with modifications of a
currently approved data collection. A
second Notice of Correction was
published in the Federal Register in
Vol. 82, No. 20896 on May 4, 2017,
announcing that the web location of the
proposed information collection would
change due to an update of the ACL.gov
Web site.
ACL received comments from eightynine (89) organizations and just over
13,900 individuals about the National
Survey of Older Americans Act
Participants (NSOAAP). ACL reviewed
all of the comments. Eight (8) of the
comments were deemed not relevant
because they were: (a) Programmatic in
nature and not survey-related; (b)
referencing other data collections and
not the NSOAAP (e.g., Census); or (c)
commentary without reference to the
NSOAAP. The majority of the comments
that ACL received expressed the need to
retain demographic questions on sexual
orientation/gender identity. In addition,
comments addressed: (a)
Methodological, survey design, and
sampling considerations; (b) concern
about the survey length; and (c)
recommendations to modify and/or add
clarifying questions throughout the
survey. ACL has made minor changes to
the survey based on some suggested
changes, including retaining the
primary question regarding sexual
orientation. This survey has remained
essentially the same since the last OMB
approval on 7/17/2014 (OMB Control
Number 0985–0023), and the sampling
methodology and the data collection
procedures are identical to the previous
survey approved in 2014.
Burden Estimates
Descriptions of previous National
Surveys of OAA Participants can be
found under the section on OAA
Performance Information on ACL’s Web
site at: https://www.acl.gov/programs/
oaa-performance-information. Copies of
the survey instruments and data from
previous National Surveys of OAA
Participants can be found and queried
using the AGing Integrated Database
(AGID) at https://agid.acl.gov/. The
proposed National Survey entitled
National Survey of Older Americans Act
Participants 2017 Revised may be found
on the ACL Web site at: https://
www.acl.gov/about-acl/public-input.
The revisions, including the
reinstatement of the primary question
on sexual orientation, represent minor
changes in terms of data collection
burden that do not change the overall
estimated burden on respondents.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Respondent/data collection activity
Responses
per
respondent
Hours per
response
Annual burden
hours
Area Agency on Aging: Respondent selection process ......................
Service Recipients (i.e., Congregate and Home-delivered meal nutrition programs; Case Management, Homemaker, and Transportation Services).
National Family Caregiver Support Program Clients ..........................
250
4,000
1
1
4.0 .............................
.6667 .........................
1,000
2,666.80
2,000
1
.6667 .........................
1,333.40
Total ..............................................................................................
6,250
1
.80 (weighted mean)
Estimated Total Annual Burden
Hours: 5,000.
Dated: June 16, 2017.
Daniel P. Berger,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2017–13030 Filed 6–21–17; 8:45 am]
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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.
Fax written comments on the
collection of information by July 24,
2017.
DATES:
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 0910–0716. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sradovich on DSK3GMQ082PROD with NOTICES
[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.
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
VerDate Sep<11>2014
16:08 Jun 21, 2017
Jkt 241001
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
5,000
20852, 301–796–8867, 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:
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
E:\FR\FM\22JNN1.SGM
22JNN1
Federal Register / Vol. 82, No. 119 / Thursday, June 22, 2017 / Notices
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
28493
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.
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
Activity and FDA Form 3779
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Reporting violations of the FD&C Act, as
amended by the Tobacco Control Act via telephone, Internet form, mail, smartphone application, or email.
750
2
1,500
0.25 (15 minutes) ...........
375
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
sradovich on DSK3GMQ082PROD with NOTICES
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
VerDate Sep<11>2014
16:08 Jun 21, 2017
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–3615]
Administering the Hatch-Waxman
Amendments: Ensuring a Balance
Between Innovation and Access;
Public Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the following meeting: ‘‘The
Hatch-Waxman Amendments: Ensuring
a Balance Between Innovation and
Access.’’ This public meeting is
intended to provide the public an
opportunity to submit comments
concerning administration of the HatchWaxman Amendments to the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) to help ensure the intended balance
between encouraging innovation in drug
development and accelerating the
availability to the public of lower cost
alternatives to innovator drugs is
maintained.
SUMMARY:
The meeting will be held on July
18, 2017, from 9 a.m. to 5 p.m. The
deadline for submitting comments
DATES:
Jkt 241001
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Frm 00026
Fmt 4703
Sfmt 4703
regarding this meeting is September 18,
2017.
ADDRESSES: The meeting will be held at
the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1, where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before September 18, 2017. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of September 18, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
E:\FR\FM\22JNN1.SGM
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Agencies
[Federal Register Volume 82, Number 119 (Thursday, June 22, 2017)]
[Notices]
[Pages 28492-28493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13018]
-----------------------------------------------------------------------
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 oira_submission@omb.eop.gov. 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,
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.
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