Determination of Regulatory Review Period for Purposes of Patent Extension; ATRYN; Correction, 21381 [2011-9153]
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Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices
reading the news article, participants
will complete a questionnaire assessing
their emotional response, appraisals,
attribution of responsibility, perceptions
about the safety of the affected produce,
intentions to grow, sell, or buy the
affected produce, perceived probability
of a repeat event, and a measure of their
innate ability to effectively respond to
the information in the article.
To help design and refine the
questionnaire, we will recruit 25
participants in order to conduct 10
cognitive interviews. We estimate
cognitive interview recruitment will
take 5 minutes (0.083 hours), for a total
of 2 hours. The cognitive interviews are
estimated at 1 hour per response for a
total of 10 hours for the cognitive
interview activities. We expect to send
screeners to 800 members of a consumer
panel, each taking 2 minutes (0.03
hours) to complete, for a total of 24
hours for the consumer panel screener
activity. We also expect to administer
360 screeners to growers and retailers,
each taking 2 minutes (0.033 hours) to
complete, for a total of 24 hours (11 +
11 = 22). Twenty-four participants (20
consumers, 2 growers, 2 retailers) will
complete the pre-test. Each pre-test will
take 10 minutes (0.17 hours) for a total
of 5 hours for the pre-test activity. We
estimate that 900 individuals (540
consumers, 180 growers, and 180
retailers) will complete the
questionnaire for the experiment, each
taking 10 minutes (0.17 hours) for a total
of 153 hours for the experimental study
activities. The estimated total hour
burden of the collection of information
is 215 hours.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Portion of study
Number of
responses per
respondent
Total annual
responses
Average
burden
per response
(in hours) 2
Total hours
Cognitive Interview Recruitment ..........................................
Cognitive Interviews .............................................................
Consumer Panel Screener ..................................................
Grower Screener ..................................................................
Retailer Screener .................................................................
Pre-tests ...............................................................................
Experiment ...........................................................................
25
10
800
360
360
24
900
1
1
1
1
1
1
1
25
10
800
360
360
24
900
5/60
1
2/60
2/60
2/60
10/60
10/60
2
10
24
11
11
5
153
Total ..............................................................................
........................
........................
........................
........................
216
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
2 Burden
II. References
11. Olsen, S., L. MacKinon, et al.,
‘‘Surveillance for Foodborne Disease
Outbreaks—United States, 1993 to1997,’’
Morbidity and Mortality Weekly Report
49(SS01), pp. 1 through 51, 2000.
2. FDA 101: Product Recalls—From First
Alert to Effectiveness Checks, Available
at https://www.fda.gov/ForConsumers/
ConsumerUpdates/ucm049070.htm.
3. Calvin, L., ‘‘Outbreak Linked to Spinach
Forces Reassessment of Food Safety
Practices,’’ Amber Waves 5(3), pp. 24
through 31, 2007.
4. Lucier, G. and R. Dettmann, ‘‘Vegetables
and Melons Outlook,’’ A Report From the
United States Department of Agriculture,
Economic Research Service, VGS–327,
June 26, 2008.
Dated: April 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–9155 Filed 4–14–11; 8:45 am]
BILLING CODE 4160–01–P
[Docket No. FDA–2009–E–0241]
21, 2011, the following correction is
made:
1. On page 15323, in the first column,
in the Docket No. heading, ‘‘[Docket No.
FDA–2010–E–0241]’’ is corrected to read
‘‘[Docket No. FDA–2009–E–0241]’’.
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ATRYN; Correction
Dated: April 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2011–9153 Filed 4–14–11; 8:45 am]
AGENCY:
Food and Drug Administration,
BILLING CODE 4160–01–P
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of March 21, 2011 (76 FR
15323). The document announced the
determination of the regulatory review
period for ATRYN. The document was
published with an incorrect docket
number. This document corrects that
error.
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSKHWCL6B1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy, Planning
and Budget, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 3208, Silver Spring,
MD 20993–0002, 301–796–9138.
SUPPLEMENTARY INFORMATION: In FR Doc.
2011–6509, appearing on page 15323, in
the Federal Register of Monday, March
VerDate Mar<15>2010
16:58 Apr 14, 2011
Jkt 223001
ACTION:
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pediatric
Advisory Committee.
PO 00000
Frm 00064
Fmt 4703
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Notice.
15APN1
]]>Agencies
[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Notices]
[Page 21381]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9153]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-E-0241]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ATRYN; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of March 21, 2011 (76 FR 15323).
The document announced the determination of the regulatory review
period for ATRYN. The document was published with an incorrect docket
number. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy,
Planning and Budget, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 3208, Silver Spring, MD 20993-0002, 301-796-9138.
SUPPLEMENTARY INFORMATION: In FR Doc. 2011-6509, appearing on page
15323, in the Federal Register of Monday, March 21, 2011, the following
correction is made:
1. On page 15323, in the first column, in the Docket No. heading,
``[Docket No. FDA-2010-E-0241]'' is corrected to read ``[Docket No.
FDA-2009-E-0241]''.
Dated: April 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9153 Filed 4-14-11; 8:45 am]
BILLING CODE 4160-01-P
