Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Over-the-Counter Human Drugs; Labeling Requirements, 9217 [2014-03348]
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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]
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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]
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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]
[Page 9217]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03348]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[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.
-----------------------------------------------------------------------
SUMMARY: 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.
Dated: February 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03348 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-01-P
