Agency Emergency Processing Under Office of Management and Budget Review; Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products; Labeling Comprehension Study, 5056-5057 [E7-1674]
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Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received at the address below, no
later than 5 p.m. on April 3, 2007.
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development—C, Attention:
Bonnie L Harkless, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: January 26, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–1686 Filed 2–1–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0036]
Agency Emergency Processing Under
Office of Management and Budget
Review; Toll-Free Number for
Reporting Adverse Events on Labeling
for Human Drug Products; Labeling
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 emergency processing under
the Paperwork Reduction Act of 1995
(the PRA). The proposed collection of
information concerns an experimental
study to test labeling statement
alternatives for certain prescription and
over-the-counter (OTC) drug product
labeling.
Fax written comments on the
collection of information by March 5,
2007.
DATES:
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 docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
sroberts on PROD1PC70 with NOTICES
ADDRESSES:
VerDate Aug<31>2005
16:13 Feb 01, 2007
Jkt 211001
Lane, Rockville, MD 20857, 301–827–
1482.
FDA has
requested emergency processing of this
proposed collection of information
under section 3507(j) of the PRA (44
U.S.C. 3507(j)) and 5 CFR 1320.13. This
information is needed prior to the
expiration of the normal time periods
for OMB clearance under the PRA
regulations (5 CFR part 1320) and is
essential to the agency’s mission to
protect the public health and safety.
Section 17 of the Best Pharmaceuticals
for Children Act (the BPCA) (Public Law
107–109) requires FDA to issue a final
rule mandating the addition of a
statement to the labeling of each drug
product for which an application is
approved under section 505 of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 355). Under the
BPCA, the labeling statement is required
to include: (1) A toll-free number for
consumers to use to report drug product
side effects and (2) a statement that the
number is to be used only for reporting
side effects and is not intended to seek
or obtain medical advice (the side
effects statement). The use of normal
clearance procedures would further
delay FDA’s issuance of a final rule to
comply with this congressional
mandate.
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.
SUPPLEMENTARY INFORMATION:
Toll-Free Number for Reporting
Adverse Events on Labeling for Human
Drug Products; Labeling
Comprehension Study
On April 22, 2004 (69 FR 21778), FDA
published a proposed rule with a
proposed side effects statement for
certain prescription drug product
labeling and a proposed side effects
statement for certain OTC drug product
labeling. In the proposed rule, FDA
solicited comments on the wording of
these side effects statements. We
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
received 12 comments suggesting
changes to the specific wording of the
proposed side effects statements. We
also received several comments
suggesting that FDA engage in research
to study consumer comprehension of
the wording of the proposed side effects
statements. Among the reasons cited for
testing the statements were: (1) To
determine the best and most precise
wording for the statements, (2) to
evaluate consumer comprehension of
the proposed statements, and (3) to
address concerns that consumers who
read the statement will mistakenly call
FDA in search of medical advice. In
addition, during the clearance process
for the proposed rule, both the Office of
Information and Regulatory Affairs of
OMB and the Office of the Assistant
Secretary for Planning and Evaluation of
the Department of Health and Human
Services suggested that FDA conduct
consumer studies on the wording of the
side effects statements. After the
publication of the proposed rule and
based on the comments received, FDA
decided to conduct research to study the
wording of the proposed side effects
statements before issuing a final rule.
FDA conducted two focus groups
(OMB Control No. 0910–0497) to narrow
the field of potential statement
alternatives. Based on the findings from
the focus groups, FDA has selected
several statements for quantitative
testing in an experimental study of
consumer comprehension. The
experimental study will test several
ways of stating the required information
for maximum comprehension of factual
information and necessary action. The
experimental study will provide
quantitative data to inform FDA’s
selection of the side effects statements
to fulfill the requirements of the BPCA.
Each participant will be exposed to only
one side effects statement, in a
‘‘between-subjects’’ or ‘‘monadic’’
design. Participants initially will see
one statement in the context of either a
prescription drug bottle or an OTC Drug
Facts label, depending on which
condition they are in, and will all
answer the same series of questions. For
the remainder of the study, each
participant will see the statement as
they answer questions specifically about
the statement. The experimental study
data will be collected via the Internet
from members of a consumer panel
maintained by an external research
organization. Panel members are
recruited by a variety of means designed
to reflect all segments of the population.
They are required to have a computer
with Internet access. Studies begin with
an e-mailed invitation to the sampled
E:\FR\FM\02FEN1.SGM
02FEN1
5057
Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices
respondents. Each panel member has
provided demographic data for their
household that allows for the selection
of samples that resemble closely the
distribution of the U.S. population on
age, gender, education, and race/
ethnicity. A participant recruitment
questionnaire (screener) will be used to
planned. Testing the statements
experimentally will provide valuable
information on the comprehension,
usefulness, and selection of the side
effect statements to be included in the
final rule.
FDA estimates the burden of this
collection of information as follows:
ensure recruitment criteria are met.
Conventional statistical techniques for
experimental data (such as descriptive
statistics, analysis of variance, and
regression models) will be used to
analyze the data. This proposed data
collection will be one-time only. No
successive related data collections are
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
Annual Frequency per
Response
Total Annual
Responses
Hours per
Response
Total Hours
Administration of Participant Screener
1,684
1
1,684
0.01
17
Administration of Participant Questionnaire
1,600
1
1,600
0.15
240
Total
257
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–1674 Filed 2–1–07; 8:45 am]
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
BILLING CODE 4160–01–S
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0430]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension, Postmarketing Studies
Status Reports, and Forms FDA 456h
and 2567
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 March 5,
2007.
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.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
sroberts on PROD1PC70 with NOTICES
ADDRESSES:
VerDate Aug<31>2005
16:13 Feb 01, 2007
Jkt 211001
General Licensing Provisions: Biologics
License Application, Changes to an
Approved Application, Labeling,
Revocation and Suspension,
Postmarketing Studies Status Reports,
and Forms FDA 456h and 2567—(OMB
Control Number 0910–0338)—Extension
Under section 351 of the Public
Health Service Act (the PHS Act) (42
U.S.C. 262), manufacturers of biological
products must submit a license
application for FDA review and
approval before marketing a biological
product in interstate commerce.
Licenses may be issued only upon
showing that the establishment and the
products for which a license is desired
meets standards prescribed in
regulations designed to ensure the
continued safety, purity, and potency of
such products. All such licenses are
issued, suspended, and revoked as
prescribed by regulations in part 601 (21
CFR part 601).
Section 130(a) of the Food and Drug
Administration Modernization Act
(Public Law 105–115) amended the
Federal Food, Drug, and Cosmetic Act
(the act) by adding a new provision
(section 506B of the act (21 U.S.C.
356b)) requiring reports of
postmarketing studies for approved
human drugs and licensed biological
products. Section 506B of the act
provides FDA with additional authority
to monitor the progress of postmarketing
studies that applicants have made a
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
commitment to conduct and requires
the agency to make publicly available
information that pertains to the status of
these studies.
Under section 506B(a) of the act,
applicants that have committed to
conducting a postmarketing study for an
approved human drug or licensed
biological product must submit to FDA
a status report of the progress of the
study or the reasons for the failure of the
applicant to conduct the study. This
report must be submitted within 1 year
after the U.S. approval of the
application and then annually until the
study is completed or terminated.
Section 601.2(a) requires a
manufacturer of a biological product to
submit an application with
accompanying information, including
labeling information, to FDA for
approval to market a product in
interstate commerce. The container and
package labeling requirements are
provided under §§ 610.60, 610.61, and
610.62 (21 CFR part 610). The estimate
for these regulations is included in the
estimate under § 601.2(a) in table 1 of
this document. Section 601.5(a) requires
a licensee to submit to FDA notice of its
intention to discontinue manufacture of
a product or all products. Section
601.6(a) requires the licensee to notify
selling agents and distributors upon
suspension of its license, and provide
FDA of such notification.
Section 601.12(a)(2) requires,
generally, that the holder of an
approved BLA must assess the effects of
a manufacturing change before
distributing a biological product made
with the change. Section 601.12(a)(4)
requires, generally, that the applicant
must promptly review all promotional
labeling and advertising to make it
consistent with any labeling changes
implemented. Section 601.12(a)(5)
E:\FR\FM\02FEN1.SGM
02FEN1
]]>Agencies
[Federal Register Volume 72, Number 22 (Friday, February 2, 2007)]
[Notices]
[Pages 5056-5057]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1674]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0036]
Agency Emergency Processing Under Office of Management and Budget
Review; Toll-Free Number for Reporting Adverse Events on Labeling for
Human Drug Products; Labeling 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 emergency processing under the
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of
information concerns an experimental study to test labeling statement
alternatives for certain prescription and over-the-counter (OTC) drug
product labeling.
DATES: Fax written comments on the collection of information by March
5, 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 docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of
this proposed collection of information under section 3507(j) of the
PRA (44 U.S.C. 3507(j)) and 5 CFR 1320.13. This information is needed
prior to the expiration of the normal time periods for OMB clearance
under the PRA regulations (5 CFR part 1320) and is essential to the
agency's mission to protect the public health and safety. Section 17 of
the Best Pharmaceuticals for Children Act (the BPCA) (Public Law 107-
109) requires FDA to issue a final rule mandating the addition of a
statement to the labeling of each drug product for which an application
is approved under section 505 of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 355). Under the BPCA, the labeling statement
is required to include: (1) A toll-free number for consumers to use to
report drug product side effects and (2) a statement that the number is
to be used only for reporting side effects and is not intended to seek
or obtain medical advice (the side effects statement). The use of
normal clearance procedures would further delay FDA's issuance of a
final rule to comply with this congressional mandate.
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.
Toll-Free Number for Reporting Adverse Events on Labeling for Human
Drug Products; Labeling Comprehension Study
On April 22, 2004 (69 FR 21778), FDA published a proposed rule with
a proposed side effects statement for certain prescription drug product
labeling and a proposed side effects statement for certain OTC drug
product labeling. In the proposed rule, FDA solicited comments on the
wording of these side effects statements. We received 12 comments
suggesting changes to the specific wording of the proposed side effects
statements. We also received several comments suggesting that FDA
engage in research to study consumer comprehension of the wording of
the proposed side effects statements. Among the reasons cited for
testing the statements were: (1) To determine the best and most precise
wording for the statements, (2) to evaluate consumer comprehension of
the proposed statements, and (3) to address concerns that consumers who
read the statement will mistakenly call FDA in search of medical
advice. In addition, during the clearance process for the proposed
rule, both the Office of Information and Regulatory Affairs of OMB and
the Office of the Assistant Secretary for Planning and Evaluation of
the Department of Health and Human Services suggested that FDA conduct
consumer studies on the wording of the side effects statements. After
the publication of the proposed rule and based on the comments
received, FDA decided to conduct research to study the wording of the
proposed side effects statements before issuing a final rule.
FDA conducted two focus groups (OMB Control No. 0910-0497) to
narrow the field of potential statement alternatives. Based on the
findings from the focus groups, FDA has selected several statements for
quantitative testing in an experimental study of consumer
comprehension. The experimental study will test several ways of stating
the required information for maximum comprehension of factual
information and necessary action. The experimental study will provide
quantitative data to inform FDA's selection of the side effects
statements to fulfill the requirements of the BPCA. Each participant
will be exposed to only one side effects statement, in a ``between-
subjects'' or ``monadic'' design. Participants initially will see one
statement in the context of either a prescription drug bottle or an OTC
Drug Facts label, depending on which condition they are in, and will
all answer the same series of questions. For the remainder of the
study, each participant will see the statement as they answer questions
specifically about the statement. The experimental study data will be
collected via the Internet from members of a consumer panel maintained
by an external research organization. Panel members are recruited by a
variety of means designed to reflect all segments of the population.
They are required to have a computer with Internet access. Studies
begin with an e-mailed invitation to the sampled
[[Page 5057]]
respondents. Each panel member has provided demographic data for their
household that allows for the selection of samples that resemble
closely the distribution of the U.S. population on age, gender,
education, and race/ethnicity. A participant recruitment questionnaire
(screener) will be used to ensure recruitment criteria are met.
Conventional statistical techniques for experimental data (such as
descriptive statistics, analysis of variance, and regression models)
will be used to analyze the data. This proposed data collection will be
one-time only. No successive related data collections are planned.
Testing the statements experimentally will provide valuable information
on the comprehension, usefulness, and selection of the side effect
statements to be included in the final rule.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
Activity Respondents Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Administration 1,684 1 1,684 0.01 17
of Participant
Screener
----------------------------------------------------------------------------------------------------------------
Administration 1,600 1 1,600 0.15 240
of Participant
Questionnaire
----------------------------------------------------------------------------------------------------------------
Total .................. ..................... .................. ............... 257
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: January 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-1674 Filed 2-1-07; 8:45 am]
BILLING CODE 4160-01-S
