Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction, 76049-76050 [2012-31027]
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76049
Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Notices
provide information on the effectiveness
of FDA guidance on this issue.
(Comment 8) Two comments
expressed concern that the time delay
conditions were not realistic, stating
that a time delay of 6 months to a year
might be more realistic.
(Response) We agree that a 6-month
exposure delay more closely
approximates real-world exposure to
original and corrective messaging. In
response to concerns about the realism
of our approach, we have changed the
study design in two ways (see Table 2).
First, participants will view the stimuli
embedded in a ‘‘clutter reel’’ of other
ads three times over a 3-week period to
approximate multiple exposures in a
real-world context. Second, we have
added a 6-month delay condition.
(Comment 9) One comment critiqued
the references included in the 60-day
Federal Register notice, stating:
‘‘* * * the references offered in the instant
[sic] notice seemed less concerned with
presenting corrective advertising in a manner
most likely to inform the consumer about the
safety and efficacy of a given product and
more concerned with determining whether
the corrective ad might be bad for sales.
Furthermore, the only example of application
of a judicial remedy to enforce corrective
advertising cited by one of these references
distorted the clear intent of the opinion
cited.’’
(Response) Some of the research on
corrective advertising, as the
commentator notes, has assessed
potential damage to an advertiser’s
reputation. Darke and colleagues (2008,
Ref. 1) note the possibility of
reputational damage, for example. Other
papers cited in the 60-day notice,
though, do not focus primarily on
reputational damage. Mazis’ work, both
in the 1970s and 1980s and then again
more recently (e.g., Mazis, 2001, Ref. 6),
as we have seen a resurgence of
corrective advertising, has been
concerned with the efficacy of
corrective messages. Mazis and
colleagues (1983, Ref. 3), for example,
focused attention on the extent to which
viewers actually noticed and
remembered the corrective message
inserted into Listerine ads. Moreover,
our study was designed to address a gap
in the literature—there is scant work on
the specific efficacy of televised
corrective ads intended to address
claims made regarding prescription
drugs—rather than to simply extend and
replicate past literature. The primary
focus of our study is correction of
misperceptions that arise from
prescription drug advertising. The
dependent variables we describe in the
60-day notice do not include advertiser
reputation but rather are comprised of
constructs such as belief in advertised
claims that overstate efficacy or
minimize risk, perceived risk of the
advertised drug, and perceived efficacy
of the advertised drug.
Please note that in response to all
comments received, whether we have
adopted the suggestions or not, we will
specifically examine the items
mentioned in cognitive testing. During
this testing, nine respondents will
participate in the survey while
explaining why and how they have
chosen their answers and which
questions they find difficult to respond
to or to understand.
FDA estimates the burden of this
collection of information as follows:
TABLE 3—ESTIMATED BURDEN 1
Activity
No. of respondents
No. of responses per
respondent
Total annual
responses
Average burden
response
Total hours
Sample availability (pretests and main survey) ...............
Screener completes (60%) ..............................................
Eligible (85%) ...................................................................
Pretest (stimuli) completes (65%) ....................................
Pretest (questionnaire) completes (65%) ........................
Phase 1 completes (65%) ...............................................
Phase 2 completes (45%) ...............................................
Pretest/Study completes ..................................................
Total ..........................................................................
24,635
14,891
12,658
1,450
200
1,000
4,000
6,650
........................
........................
1
........................
1
1
1
1
........................
........................
........................
14,891
........................
1,450
200
1,000
4,000
........................
........................
............................
0.0333
............................
0.333
0.5
.416
1
............................
............................
........................
496
........................
483
100
417
4,000
........................
5,496
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates the total annual
estimated burden imposed by this
collection of information as 5,496 hours
for this one-time collection.
V. References
tkelley on DSK3SPTVN1PROD with
The following references have been
placed on display at the Division of
Dockets Management and may be seen
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday
(FDA has verified the Web site
addresses of the following references,
but FDA is not responsible for any
subsequent changes to the Web sites
after this document publishes in the
Federal Register).
1. Darke, P. R., Ashworth, L., and Ritchie, R.
J. B. (2008). Damage from corrective
advertising: Causes and cures. Journal of
Marketing, 72, 81–97;
2. Mazis, M. B. & Adkinson, J. E. (1976). An
VerDate Mar<15>2010
06:31 Dec 22, 2012
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experimental evaluation of a proposed
corrective advertising remedy. Journal of
Marketing Research, 13, 178–183.
3. Mazis, M. B., McNeill, D. L., & Bernhardt,
K. L. (1983). Day-after recall of Listerine
corrective commercials. Journal of Public
Policy & Marketing, 2, 29–37.
4. Singer, N. (2009, February 11). A birth
control pill that promised too much. The
New York Times, p. B1.
5. From Guidance for Industry: ‘‘HelpSeeking’’ and Other Disease Awareness
Communications by or on Behalf of Drug
and Device Firms. Available at https://
www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/ucm070068.pdf.
Last accessed November 23, 2012.
6. Mazis, M. B. (2001). FTC v. Novartis: The
return of corrective advertising? Journal
of Public Policy & Marketing, 20, 114–
122.
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Dated: December 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–31028 Filed 12–21–12; 4:15 pm]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0643]
Draft Guidance for Industry on
Electronic Source Data in Clinical
Investigations; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\26DEN1.SGM
Notice; correction.
26DEN1
76050
Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Notices
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of Tuesday, November 20, 2012
(77 FR 69632). The document
announced the availability of a draft
guidance entitled ‘‘Electronic Source
Data in Clinical Investigations.’’ The
document was published with an
incorrect date in the DATES section. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT: Ron
Fitzmartin, Office of Planning &
Informatics, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1160, Silver Spring,
MD 20993–0002, 301–796–5333, FAX:
301–847–8443.
SUPPLEMENTARY INFORMATION: In FR Doc.
2012–28198, appearing on page 69632
in the Federal Register of Tuesday,
November 20, 2012, the following
correction is made:
1. On page 69632, in the third
column, in the DATES section, the date
‘‘January 22, 2013’’ is corrected to read
‘‘March 26, 2013.’’
SUMMARY:
Dated: December 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–31027 Filed 12–21–12; 4:15 pm]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0899]
Draft Environmental Assessment and
Preliminary Finding of No Significant
Impact Concerning a Genetically
Engineered Atlantic Salmon;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency) is
announcing the availability for public
comment of the Agency’s draft
environmental assessment (EA) of the
proposed conditions of use specified in
materials submitted by AquaBounty
Technologies, Inc., in support of a new
animal drug application (NADA)
concerning a genetically engineered
(GE) Atlantic salmon. Also available for
comment is the Agency’s preliminary
finding of no significant impact (FONSI)
for those specific conditions of use.
DATES: Submit either electronic or
written comments on the Agency’s draft
tkelley on DSK3SPTVN1PROD with
SUMMARY:
VerDate Mar<15>2010
06:31 Dec 22, 2012
Jkt 229001
EA and preliminary FONSI by February
25, 2013.
ADDRESSES: Submit electronic
comments to: https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Eric
Silberhorn, Center for Veterinary
Medicine (HFV–162), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8247,
email:abig@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Notice is
given that a draft EA prepared by FDA
in support of an NADA associated with
AQUADVANTAGE Salmon, a GE
Atlantic salmon containing the opAFP–
GHc2 recombinant DNA construct is
being made available for public
comment. FDA is also making available
for comment the Agency’s preliminary
FONSI for those specific conditions of
use. In the event of an approval of the
application, the approval would only
allow AQUADVANTAGE Salmon to be
produced and grown-out in the
physically contained freshwater culture
facilities specified in the sponsor’s
NADA.
To encourage public participation
consistent with regulations
implementing the National
Environmental Policy Act (40 CFR
1501.4(b)), the Agency is placing the
draft EA and the preliminary FONSI
that are the subject of this notice on
public display at the Division of Dockets
Management (see DATES and ADDRESSES)
for public review and comment for 60
days. Given that the substance of this
draft EA was made available to the
public in advance of the Agency’s 2010
Veterinary Medicine Advisory
Committee meeting and consistent with
the Agency’s regulations implementing
the National Environmental Policy Act
(21 CFR 25.51(b)(3)), FDA believes that
a 60-day comment period is appropriate
and does not intend to grant requests for
extension of the comment period.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
FDA will also place on public display
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any amendments to, or comments on,
the Agency’s draft EA and preliminary
FONSI without further announcement
in the Federal Register.
If, based on its review, the Agency
finds that an environmental impact
statement is not required and the NADA
results in an approval by the Agency,
the notice of availability of the Agency’s
EA and FONSI, as well as any
supporting evidence, will be published
with the regulation describing the
approval in the Federal Register in
accordance with 21 CFR 25.51(b).
Dated: December 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–31118 Filed 12–21–12; 11:15 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Public Workshop on Minimal Residual
Disease; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA), in cosponsorship
with the American Society of Clinical
Oncology, is announcing a public
workshop that will provide a forum for
discussion of extending the
qualification of minimal residual
disease (MRD) detection as a prognostic
biomarker to an efficacy/response
biomarker in evaluating new drugs for
the treatment of acute myeloid leukemia
(AML). Our objective is for the
workshop to provide a venue for an indepth discussion of potential endpoints
for trials intended to support the
approval of new drugs or biologics for
treatment of AML. Participants in the
workshop will examine if any currently
used biomarker can be used as a
surrogate endpoint, identify the
preferred technology platform and
performance characteristics for the assay
of the biomarker, discuss any issues
regarding ongoing deficiencies in
methodological standardization for the
biomarker, and determine the need for
additional FDA-approved in-vitro
diagnostics for AML drug development.
The primary focus will be on the
biomarkers that are or will soon be
ready for incorporation into clinical
trials, and the technical and regulatory
challenges for use of these markers.
SUMMARY:
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26DEN1
]]>Agencies
[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Notices]
[Pages 76049-76050]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31027]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0643]
Draft Guidance for Industry on Electronic Source Data in Clinical
Investigations; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
[[Page 76050]]
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of Tuesday, November 20, 2012 (77
FR 69632). The document announced the availability of a draft guidance
entitled ``Electronic Source Data in Clinical Investigations.'' The
document was published with an incorrect date in the DATES section.
This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Office of Planning &
Informatics, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1160, Silver
Spring, MD 20993-0002, 301-796-5333, FAX: 301-847-8443.
SUPPLEMENTARY INFORMATION: In FR Doc. 2012-28198, appearing on page
69632 in the Federal Register of Tuesday, November 20, 2012, the
following correction is made:
1. On page 69632, in the third column, in the DATES section, the
date ``January 22, 2013'' is corrected to read ``March 26, 2013.''
Dated: December 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-31027 Filed 12-21-12; 4:15 pm]
BILLING CODE 4160-01-P
