Agency Information Collection Activities; Proposed Collection; Comment Request; Label Comprehension Study, 7661-7662 [E7-2716]
Download as PDF
<![CDATA[
Federal Register / Vol. 72, No. 32 / Friday, February 16, 2007 / Notices
2Electronic
submissions received between July 1, 2005, and June 30, 2006.
The number of respondents in table 1
of this document is the number of
sponsors registered to make electronic
submissions (25). The number of total
annual responses is based on a review
of the actual number of submissions
made between July 1, 2005, and June 30,
2006 (2 x hours per response (.41) = .82
total hours).
Submitting a slaughter notice
electronically represents an alternative
to submitting a notice of intent to
slaughter on paper. The reporting
burden for compilation and submission
of this information on paper is included
in OMB clearance of the information
collection provisions of 21 CFR 511.1
(OMB No. 0910–0450). The estimates in
table 1 of this document reflect the
burden associated with putting the same
information on FDA Form #3488 and
resulted from previous discussions with
sponsors about the time necessary to
complete this form.
Dated: February 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–2710 Filed 2–15–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0050]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Label
Comprehension Study
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
SUMMARY: 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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a questionnaire to evaluate reader’s
comprehension of three versions of
VerDate Aug<31>2005
7661
19:03 Feb 15, 2007
Jkt 211001
condom labeling through a label
comprehension study.
DATES: Submit written or electronic
comments on the collection of
information by April 17, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
when appropriate, and other forms of
information technology.
Label Comprehension Study (U.S.C. 393
(d)(2)(C))
FDA issued the ‘‘Draft Guidance for
Industry and FDA Staff: Class II Special
Controls Guidance Document: Labeling
for Male Condoms Made of Natural
Rubber Latex’’ on November 14, 2005
(70 FR 69156). Section 21 U.S.C.
393(d)(2)(C) of the Federal Food, Drug
and Cosmetic Act (the act) states that
the Secretary, through the
Commissioner, shall be responsible to
conduct research relating to devices in
carrying out this chapter. In order to
evaluate the understandability of the
condom labeling language currently on
the market and the labeling language
proposed in this draft guidance, as well
as a future revised version of the
labeling, FDA plans to evaluate readers’
comprehension of three versions of
condom labeling through a label
comprehension study.
The proposed label comprehension
study will measure current and
potential condom consumers’
understanding of the current market
labeling and the proposed condom
labeling in the draft guidance of the
retail package, foil and package insert of
condom labeling, as well as a future
revised version of the labeling. The label
comprehension study will follow a
sequential design, first testing both the
current market labeling (Part A) and the
draft labeling in the guidance (Part B) in
Stage 1, and then a revised version of
the labeling in Stage 2.
FDA will conduct a label
comprehension study via a mall
intercept/central location intercept
methodology with pre-screened
participants. FDA will administer a
screening instrument, the REALM
(Rapid Estimate of Adult Literacy in
Medicine) test, an informed consent,
and a questionnaire with approximately
20 questions related to the condom
labeling language to a total of 1,200
participants: 400 participants for Part A
of Stage 1, 400 participants for Part B of
Stage 1, and 400 participants for Stage
2 of the study. Results of the study will
be considered in FDA’s condom labeling
recommendations to provide important
risk/benefit and use information
associated with condoms in an easily
understood language.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\16FEN1.SGM
16FEN1
7662
Federal Register / Vol. 72, No. 32 / Friday, February 16, 2007 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of Respondents
Activity
Screening Tool
Annual Frequency
per Response
Total Annual Responses
Hours per Response
Total Hours
3,300
1
3,300
.05
165
Stage 1: Part A—REALM test; Informed Consent;
Read Labeling; Questionnaire
400
1
400
.45
180
Stage 1: Part B—REALM test; Informed Consent;
Read Labeling; Questionnaire
400
1
400
.45
180
Stage 2—REALM test; Informed Consent; Read
Labeling; Questionnaire
400
1
400
.45
180
........................
..............................
..............................
........................
705
Total
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
This was based on similar types of
FDA studies conducted in the past. FDA
has conducted both focus group studies
and label comprehension studies, where
similar participant activities, such as
reading the labeling, taking the REALM
test, signing the informed consent, and
answering questions on a selfadministered questionnaire took place.
In order to achieve the 1,200
participants for the condom label
comprehension study, FDA estimates
screening 3,300 to achieve 1,200
interviews.
Dated: February 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–2716 Filed 2–15–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N–0355]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Exception From General Requirements
for Informed Consent
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
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 March 19,
2007.
ADDRESSES: To ensure that comments on
the information collection are received,
VerDate Aug<31>2005
19:03 Feb 15, 2007
Jkt 211001
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
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.
Medical Devices; Exception From
General Requirements for Informed
Consent—(OMB Control Number 0910–
0586)—Extension
In the Federal Register of June 7, 2006
(71 FR 32827), FDA issued an interim
final rule (hereinafter referred to as the
June 7, 2006, interim final rule) to
amend its regulations to establish a new
exception from the general requirements
for informed consent, to permit the use
of investigational in vitro diagnostic
devices to identify chemical, biological,
radiological, or nuclear agents without
informed consent in certain
circumstances. The agency took this
action because it is concerned that,
during a potential terrorism event or
other potential public health emergency,
delaying the testing of specimens to
obtain informed consent may threaten
the life of the subject. In many
instances, there may also be others who
have been exposed to, or who may be
at risk of exposure to, a dangerous
chemical, biological, radiological, or
nuclear agent, thus necessitating
identification of the agent as soon as
possible. FDA created this exception to
help ensure that individuals who may
have been exposed to a chemical,
biological, radiological, or nuclear agent
are able to benefit from the timely use
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
of the most appropriate diagnostic
devices, including those that are
investigational.
FDA requested public comment on
the information collection requirements
in the June 7, 2006, interim final rule.
The collection of information
requirements for the June 7, 2006,
interim final rule were approved under
the emergency processing provisions of
the Paperwork Reduction Act (PRA),
and assigned OMB control 0910–0586.
With this approval, OMB informed the
agency that the preamble and
solicitation of public comment by the
June 7, 2006, interim final rule would
serve as a 60-day notice for the 3 year
extension of this collection of
information. In addition, OMB also
requested that FDA, in submitting its
extension request, summarize comments
received in response to the 60-day
notice, describe how the agency will
address substantive issues raised by the
commenters, and provide an update on
the status of the final rule. FDA is
responding to OMB’s requests below:
FDA received 10 comments on the
interim final rule, three of which related
to the information collection
requirements. The other comments on
the rule will be addressed in the
preamble to the final rule. FDA expects
to publish the final rule in 2009.
One comment suggested that the
requirement that a laboratory certify to
an institutional review board (IRB) that
the testing was done in a lifethreatening situation and that it was not
feasible to obtain consent serves no
purpose, since these issues have already
been pre-determined by FDA and
provide the basis for exemption. FDA
disagrees. The certification requirement
ensures that the laboratory documents
for the IRB that it is complying with the
requirements of the regulation. The
comment also stated that the
concurrence of an independent
physician, which will occur post-
E:\FR\FM\16FEN1.SGM
16FEN1
]]>Agencies
[Federal Register Volume 72, Number 32 (Friday, February 16, 2007)]
[Notices]
[Pages 7661-7662]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2716]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0050]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Label Comprehension Study
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on a questionnaire to evaluate
reader's comprehension of three versions of condom labeling through a
label comprehension study.
DATES: Submit written or electronic comments on the collection of
information by April 17, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Label Comprehension Study (U.S.C. 393 (d)(2)(C))
FDA issued the ``Draft Guidance for Industry and FDA Staff: Class
II Special Controls Guidance Document: Labeling for Male Condoms Made
of Natural Rubber Latex'' on November 14, 2005 (70 FR 69156). Section
21 U.S.C. 393(d)(2)(C) of the Federal Food, Drug and Cosmetic Act (the
act) states that the Secretary, through the Commissioner, shall be
responsible to conduct research relating to devices in carrying out
this chapter. In order to evaluate the understandability of the condom
labeling language currently on the market and the labeling language
proposed in this draft guidance, as well as a future revised version of
the labeling, FDA plans to evaluate readers' comprehension of three
versions of condom labeling through a label comprehension study.
The proposed label comprehension study will measure current and
potential condom consumers' understanding of the current market
labeling and the proposed condom labeling in the draft guidance of the
retail package, foil and package insert of condom labeling, as well as
a future revised version of the labeling. The label comprehension study
will follow a sequential design, first testing both the current market
labeling (Part A) and the draft labeling in the guidance (Part B) in
Stage 1, and then a revised version of the labeling in Stage 2.
FDA will conduct a label comprehension study via a mall intercept/
central location intercept methodology with pre-screened participants.
FDA will administer a screening instrument, the REALM (Rapid Estimate
of Adult Literacy in Medicine) test, an informed consent, and a
questionnaire with approximately 20 questions related to the condom
labeling language to a total of 1,200 participants: 400 participants
for Part A of Stage 1, 400 participants for Part B of Stage 1, and 400
participants for Stage 2 of the study. Results of the study will be
considered in FDA's condom labeling recommendations to provide
important risk/benefit and use information associated with condoms in
an easily understood language.
FDA estimates the burden of this collection of information as
follows:
[[Page 7662]]
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Screening Tool 3,300 1 3,300 .05 165
----------------------------------------------------------------------------------------------------------------
Stage 1: Part A--REALM 400 1 400 .45 180
test; Informed Consent;
Read Labeling;
Questionnaire
----------------------------------------------------------------------------------------------------------------
Stage 1: Part B--REALM 400 1 400 .45 180
test; Informed Consent;
Read Labeling;
Questionnaire
----------------------------------------------------------------------------------------------------------------
Stage 2--REALM test; 400 1 400 .45 180
Informed Consent; Read
Labeling; Questionnaire
----------------------------------------------------------------------------------------------------------------
Total .............. ................. ................. .............. 705
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
This was based on similar types of FDA studies conducted in the
past. FDA has conducted both focus group studies and label
comprehension studies, where similar participant activities, such as
reading the labeling, taking the REALM test, signing the informed
consent, and answering questions on a self-administered questionnaire
took place. In order to achieve the 1,200 participants for the condom
label comprehension study, FDA estimates screening 3,300 to achieve
1,200 interviews.
Dated: February 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2716 Filed 2-15-07; 8:45 am]
BILLING CODE 4160-01-S
