Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Label Comprehension Study, 33232-33233 [E7-11528]
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33232
Federal Register / Vol. 72, No. 115 / Friday, June 15, 2007 / Notices
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,
including each proposed extension of an
existing 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.
Animal Drug User Fee Cover Sheet;
FDA Form 3546; 21 U.S.C. 379j–12
(OMB Control Number 0910–0539)—
Extension
Under Section 740 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
379j–12), as amended by the Animal
Drug User Fee Act of 2003 (ADUFA),
FDA has the authority to assess and
collect for certain animal drug user fees.
Because the submission of user fees
concurrently with applications and
supplements is required, review of an
application cannot begin until the fee is
submitted. The types of fees that require
a cover sheet are certain animal drug
application fees and certain
supplemental animal drug application
fees. The cover sheet, FDA Form 3546,
is designed to provide the minimum
necessary information to determine
whether a fee is required for the review
of an application or supplement, to
determine the amount of the fee
required, and to assure that each animal
drug user fee payment and each animal
drug application for which payment is
made, is appropriately linked to that
payment. The form, when completed
electronically, will result in the
generation of a unique payment
identification number used for tracking
the payment. FDA will use the
information collected to initiate
administrative screening of new animal
drug applications and supplements to
determine if payment has been received.
Respondents to this collection of
information are new animal drug
sponsors, applicants, or manufacturers.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 U.S.C. 379j–12
Number of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
69
1 time for each application
69
1
69
740(a)(1)
FDA Form 3546 (Cover Sheet)
jlentini on PROD1PC65 with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information
Based on FDA’s database system,
there are an estimated 140
manufacturers of products or sponsors
of new animal drugs potentially subject
to ADUFA. However, not all
manufacturers or sponsors will have any
submissions in a given year and some
may have multiple submissions. The
total number of annual responses is
based on the number of submissions
received by FDA in fiscal year 2003. The
Center for Veterinary Medicine
estimates 69 annual responses that
include the following: 28 new animal
drug premarket approval applications
and 41 supplements. The estimated
hours per response are based on past
FDA experience with the various
submissions, and range from 30 minutes
to 1 hour. The hours per response are
based on the average of these estimates.
Dated: June 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–11527 Filed 6–14–07; 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; Submission for Office of
Management and Budget Review;
Comment Request; Label
Comprehension Study
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
VerDate Aug<31>2005
19:26 Jun 14, 2007
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Frm 00042
Fmt 4703
Sfmt 4703
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 July 16,
2007.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974. All comments should be
identified with the OMB control number
0910–NEW and title ‘‘Label
Comprehension Study.’’ Also include
the FDA 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
E:\FR\FM\15JNN1.SGM
15JNN1
33233
Federal Register / Vol. 72, No. 115 / Friday, June 15, 2007 / Notices
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.
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. The FDA will administer a
screening instrument, the Rapid
Estimate of Adult Literacy in Medicine
(REALM) 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.
In the Federal Register of February
16, 2007 (72 FR 7661), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden for this
collection of information as follows:
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
Total
jlentini on PROD1PC65 with NOTICES
1 There
705
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.
VerDate Aug<31>2005
19:26 Jun 14, 2007
Jkt 211001
Dated: June 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–11528 Filed 6–14–07; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
Frm 00043
Fmt 4703
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]]>Agencies
[Federal Register Volume 72, Number 115 (Friday, June 15, 2007)]
[Notices]
[Pages 33232-33233]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-11528]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0050]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Label Comprehension
Study
AGENCY: Food and Drug Administration, HHS.
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 July
16, 2007.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974. All comments should be identified with the OMB
control number 0910-NEW and title ``Label Comprehension Study.'' Also
include the FDA 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
[[Page 33233]]
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.
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.
The FDA will administer a screening instrument, the Rapid Estimate of
Adult Literacy in Medicine (REALM) 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.
In the Federal Register of February 16, 2007 (72 FR 7661), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per
Activity Respondents Response Total Annual Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screening Tool 3,300 1 3,300 .05 165
--------------------------------------------------------------------------------------------------------------------------------------------------------
Stage 1: Part A - REALM test; Informed 400 1 400 .45 180
Consent; Read Labeling; Questionnaire
--------------------------------------------------------------------------------------------------------------------------------------------------------
Stage 1: Part B - REALM test; Informed 400 1 400 .45 180
Consent; Read Labeling; Questionnaire
--------------------------------------------------------------------------------------------------------------------------------------------------------
Stage 2 - REALM test; Informed Consent; 400 1 400 .45 180
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: June 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11528 Filed 6-14-07; 8:45 am]
BILLING CODE 4160-01-S
