Gastrointestinal Drugs Advisory Committee; Notice of Postponement of Meeting, 59624 [2012-23885]
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59624
Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section
Number of
record-keepers
Number of
records per
record-keeper
Total annual
records
Average
burden per
record-keeping
Total hours
1140.32 (Format and content requirements for labeling
and advertising) ................................................................
1
1
1
1
1
........................
........................
........................
........................
1
Total ..............................................................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
1140.32 ................................................................................
1
1
1
1
1
srobinson on DSK4SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden hour estimates for this
collection of information were based on
industry-prepared data and information
regarding pharmaceutical advertising
and cigarette and smokeless tobacco
product advertising expenditures. The
burden collection does not include
reporting burdens associated with
providing established names on labels
and statements of intended use because
section 102 of the Tobacco Control Act
required that these provisions be struck
from the reissued final rule (previously
included in 897.24 and 897.32(c)).
Section 1140.30 (previously 897.30)
requires manufacturers, distributors,
and retailers to observe certain format
and content requirements for labeling
and advertising, and requires
manufacturers, distributors, and
retailers to notify FDA if they intend to
use an advertising medium that is not
listed in the regulations. The concept of
permitted advertising in 1140.30 is
sufficiently broad to encompass most
forms of advertising. FDA estimates that
approximately 300 respondents will
submit an annual notice of alternative
advertising, and the Agency has
estimated it should take 1 hour to
provide such notice.
For the recordkeeping and disclosure
requirements, 1140.32 (previously
897.32) requires competent and reliable
survey evidence to establish whether a
newspaper, magazine, periodical, or
other publication qualifies as an ‘‘adult’’
publication. Section 1140.32 also
requires the use of a black text on a
white background for labeling and
advertising. The respondent and hourly
burden for recordkeeping and disclosure
under this section (2 burden hours total)
reflect placeholders for the number of
manufacturers who would keep records
under this section.
VerDate Mar<15>2010
18:20 Sep 27, 2012
Jkt 226001
During the next 3 years, FDA does not
intend to enforce the recordkeeping and
disclosure requirements of 1140.32 and
has revised the burden to act as a
placeholder in the event FDA exercises
its authority to enforce the requirements
of this section in the future.
FDA estimates that the total time
required for this collection of
information is 302 hours.
Dated: September 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
301–847–8533, email:
GIDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), or visit our Web
site at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: September 25, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–23885 Filed 9–27–12; 8:45 am]
BILLING CODE 4160–01–P
[FR Doc. 2012–23833 Filed 9–27–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Food and Drug Administration
Submission for OMB Review;
Comment Request; CareerTrac
[Docket No. FDA–2012–N–0001]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is postponing the
Gastrointestinal Drugs Advisory
Committee Meeting scheduled for
October 15, 2012. This meeting was
announced in the Federal Register of
August 16, 2012 (77 FR 49446). The
postponement is due to scheduling
issues.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Cindy Hong, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, Fax:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Fogarty
International Center (FIC), National
Institute of General Medical Science
(NIGMS), National Cancer Institute
(NCI), and National Library of Medicine
(NLM) of the National Institutes of
Health (NIH), in conjunction with the
National Institute of Environmental
Health Sciences (NIEHS), including the
Intramural Research and Training
Award (IRTA) and Superfund Research
Program (SRP) within NIEHS, has
submitted to the Office of Management
and Budget (OMB) for review and
approval. This proposed information
collection was previously published in
the Federal Register, Vol. 77, No. 106,
on June 1, 2012, pages 32648–32649 and
allowed 60 days for public comment.
One public comment was received from
the Association for Research in Vision
and Ophthalmology (ARVO). The
SUMMARY:
Gastrointestinal Drugs Advisory
Committee; Notice of Postponement of
Meeting
E:\FR\FM\28SEN1.SGM
28SEN1
]]>Agencies
[Federal Register Volume 77, Number 189 (Friday, September 28, 2012)]
[Notices]
[Page 59624]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23885]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Gastrointestinal Drugs Advisory Committee; Notice of Postponement
of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is postponing the
Gastrointestinal Drugs Advisory Committee Meeting scheduled for October
15, 2012. This meeting was announced in the Federal Register of August
16, 2012 (77 FR 49446). The postponement is due to scheduling issues.
FOR FURTHER INFORMATION CONTACT: Cindy Hong, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax:
301-847-8533, email: GIDAC@fda.hhs.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), or visit our Web site at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: September 25, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-23885 Filed 9-27-12; 8:45 am]
BILLING CODE 4160-01-P
