Agency Information Collection Activities; Proposed Collection; Comment Request; National Consumer Surveys on Understanding the Risks and Benefits of FDA-Regulated Medical Products, 61490-61492 [2010-25007]
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61490
Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
with a specified biological, chemical,
radiological, or nuclear agent or
agents—in this case, Bacillus anthracis,
although there is no current domestic
emergency involving anthrax, no
current heightened risk of an anthrax
attack, and no credible information
indicating an imminent threat of an
attack involving Bacillus anthracis.
Pursuant to section 564(b) of the Federal
Food, Drug and Cosmetic Act, 21 U.S.C.
360bbb–3(b), and on the basis of such
determination, on October 1, 2008,
former Secretary of Health and Human
Services, Michael O. Leavitt, declared
an emergency justifying the
authorization of the emergency use of
doxycycline hyclate tablets
accompanied by emergency use
information subject to the terms of any
authorization issued under 21 U.S.C.
360bbb–3(a).1 Pursuant to section
564(b)(2)(B) of the Federal Food, Drug
and Cosmetic Act, 21 U.S.C. 360bbb–
3(b), and on the basis of Secretary
Chertoff’s September 23, 2008
determination, I hereby renew former
Secretary Leavitt’s October 1, 2008
declaration of an emergency, which I
previously renewed on October 1, 2009,
justifying the authorization of the
emergency use of doxycycline hyclate
tablets accompanied by emergency use
information subject to the terms of any
authorization issued under 21 U.S.C.
360bbb–3(a). I am issuing this notice in
accordance with section 564(b)(4) of the
Federal Food, Drug, and Cosmetic Act,
21 U.S.C. 360bbb–3(b)(4).
Dated: September 24, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010–24840 Filed 9–30–10; 11:15 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
OMB No.: 0970–0175.
Description: Section 466(a)(5)(C) of
the Social Security Act requires States
to pass laws ensuring a simple civil
process for voluntarily acknowledging
paternity under which the State must
provide that the mother and putative
father must be given notice, orally and
in writing, of the benefits and legal
responsibilities and consequences of
acknowledging paternity. The
information is to be used by hospitals,
birth record agencies, and other entities
participating in the voluntary paternity
establishment program that collect
information from the parents of children
that are born out of wedlock.
Respondents: The parents of children
that are born out of wedlock.
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Voluntary Establishment of
Paternity—NPRM.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
1,167,097
1
0.17
198,406.49
Estimated Total Annual Burden Hours: ....................................................
mstockstill on DSKH9S0YB1PROD with NOTICES
None .................................................................................................................
........................
........................
........................
198,406.49
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
1 Pursuant to section 564(b)(4) of the FFDCA,
notice of the determination by the Secretary, DHS,
VerDate Mar<15>2010
18:36 Oct 04, 2010
Jkt 223001
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: September 30, 2010.
Robert Sargis,
Reports Clearance Officer.
AGENCY:
[FR Doc. 2010–24893 Filed 10–4–10; 8:45 am]
SUMMARY:
Food and Drug Administration
[Docket No. FDA–2010–N–0502]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; National Consumer
Surveys on Understanding the Risks
and Benefits of FDA-Regulated Medical
Products
Food and Drug Administration,
HHS.
ACTION:
BILLING CODE 4184–01–P
Notice.
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 and to allow 60 days for
and the declaration by the Secretary, HHS, was
provided at 73 FR 58242 (October 6, 2008).
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
E:\FR\FM\05OCN1.SGM
05OCN1
61491
mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
public comment in response to the
notice. This notice solicits comments on
the National Consumer Surveys on
Understanding the Risks and Benefits of
FDA-Regulated Medical Products.
DATES: Submit either electronic or
written comments on the collection of
information by December 6, 2010.
ADDRESSES: Submit either electronic or
written comments on the collection of
information to https://
www.regulations.gov. 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:
Jonna Capezzuto, Office of Information
Management , Food and Drug
Administration, 1350 Piccard Dr., P150–
400B Rockville, MD 20850, 301–796–
3794,
JonnaLynn.Capezzuto@fda.hhs.gov.
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.
National Consumer Surveys on
Understanding the Risks and Benefits
of FDA-Regulated Medical Products
Risks and benefits are inherent in all
FDA-regulated medical products,
including drugs, biologics, and medical
devices (e.g., pacemakers, implantable
cardiac defibrillators, contact lenses,
infusion pumps). FDA plays a critical
oversight role in managing and
preventing injuries and deaths related to
medical product use. However, the
users of FDA-regulated products are
ultimately the ones who determine
which products are used and how they
are potentially misused. For this reason,
it is critical that the public understand
the risks and benefits of FDA-regulated
medical products to a degree that allows
them to make rational decisions about
product use.
FDA’s responsibility includes
communicating about medical products.
This encompasses communications that
FDA generates and those it oversees
through regulation of product
manufacturers’ and distributors’
communications. Activities include, but
are not limited to, recall notices,
warnings, public health advisories and
notifications, press releases, and
information made available on its Web
site. FDA also regulates
communications drafted and
disseminated by manufacturers and
distributors of many medical products,
including all the communications
(advertising and labeling) about
prescription drugs, biologics, and
restricted medical devices, and a subset
of communications (omitting
advertising) about nonprescription
drugs and other medical devices. In
order to conduct educational and public
information programs relating to these
responsibilities, as authorized by
Section 1003(d)(2)(D) of the Federal
Food Drug and Cosmetic Act (21 U.S.C.
section 393), it is beneficial for FDA to
conduct research and studies relating to
health information as authorized by
section 1701(a)(4) of the Public Health
Service Act (42 U.S.C. 300u(a)(4)).
In conducting such research, FDA
will employ nationally representative
surveys of consumers to assess whether
the information being disseminated by
both the agency and the entities it
regulates is appropriately reaching
targeted audiences in an understandable
fashion. Specifically, the surveys will
assess public understanding about the
benefits and risks of medical products
and FDA’s role in regulating these
products. The surveys will assess
behaviors and beliefs related to the use
of medical products, when consumers
desire emerging risk information, the
likelihood of reporting serious side
effects that might be associated with
medical product use, perceptions of the
credibility of FDA and other potential
sources of risk and benefit information,
and satisfaction with FDA’s
communications-related performance.
Parallel surveys of 1,500 noninstitutionalized U.S. adults will be
administered. One survey of 1,500
subjects will be a telephone survey, and
the second survey of another 1,500
subjects will be conducted with
members from an Internet panel. Both
survey samples will be constructed to be
representative of the U.S. population,
and both will take approximately 15
minutes to administer. Results from
each survey will be compared to
provide insight into the best
methodology for future studies.
The information collected will be
used by FDA in the development of
more effective risk communication
strategies and messages. The surveys
will provide FDA insight as to how well
the public understands and incorporates
risk/benefit information into their belief
structures, and how well the public
understands the context within which
FDA makes decisions on medical
product recalls and warnings. Using this
information, the agency will more
effectively design messages and select
formats and distribution channels that
have the greatest potential to influence
the target audience’s attitudes and
behavior in a favorable way. Frequency
of Response: On occasion. Affected
Public: Individuals or households; Type
of Respondents: Members of the public.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Type of Response
Pretests
VerDate Mar<15>2010
Annual Frequency
per Response
30
18:36 Oct 04, 2010
Jkt 223001
PO 00000
Frm 00081
Total Annual
Responses
1
Fmt 4703
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Hours per
Response
30
E:\FR\FM\05OCN1.SGM
Total Hours
0.25
05OCN1
8
61492
Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
Type of Response
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Screener
6,700
1
6,700
0.10
670
Telephone survey
1,500
1
1,500
0.25
375
Internet panel survey
1,500
1
1,500
0.25
375
Total
1,428
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on FDA’s
and the contractor’s experience with
previous surveys. Prior to administering
the surveys with the entire sample, FDA
plans to conduct pretests with up to 30
adults; these are meant to evaluate the
effectiveness of the programming of the
interview protocol, online filters, and
skip patterns.
Dated: September 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–25007 Filed 10–4–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0464]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Testing
Communications on Biological
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
communication studies involving
biological products, including vaccines
and blood products, that are regulated
by FDA. This information will be used
to explore concepts of interest and assist
in the development and modification of
communication messages and
campaigns to fulfill the Agency’s
mission to protect the public health.
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:36 Oct 04, 2010
Jkt 223001
Submit either electronic or
written comments on the collection of
information by December 6, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. 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:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
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
DATES:
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
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.
Testing Communications on Biological
Products—New
FDA is authorized by Section
1003(d)(2)(D) of the Federal Food Drug
and Cosmetic Act (21 U.S.C. Section
393(d)(2)(D)) (Attachment 2) to conduct
educational and public information
programs relating to the safety of
regulated biological products. FDA must
conduct needed research to ensure that
such programs have the highest
likelihood of being effective. FDA
expects that improving communications
about biological products including
vaccines and blood products will
involve many research methods,
including individual in-depth
interviews, mall-intercept interviews,
focus groups, self-administered surveys,
gatekeeper reviews, and omnibus
telephone surveys.
The information collected will serve
three major purposes. First, as formative
research it will provide critical
knowledge needed about target
audiences to develop messages and
campaigns about biological product use.
Knowledge of consumer and healthcare
professional decision-making processes
will provide the better understanding of
target audiences that FDA needs to
design effective communication
strategies, messages, and labels. These
communications will aim to improve
public understanding of the risks and
benefits of using biological products
including vaccines and blood products
by providing users with a better context
in which to place risk information more
completely.
Second, as initial testing, it will allow
FDA to assess the potential effectiveness
of messages and materials in reaching
and successfully communicating with
E:\FR\FM\05OCN1.SGM
05OCN1
]]>Agencies
[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61490-61492]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-25007]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0502]
Agency Information Collection Activities; Proposed Collection;
Comment Request; National Consumer Surveys on Understanding the Risks
and Benefits of FDA-Regulated Medical Products
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 and
to allow 60 days for
[[Page 61491]]
public comment in response to the notice. This notice solicits comments
on the National Consumer Surveys on Understanding the Risks and
Benefits of FDA-Regulated Medical Products.
DATES: Submit either electronic or written comments on the collection
of information by December 6, 2010.
ADDRESSES: Submit either electronic or written comments on the
collection of information to https://www.regulations.gov. 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: Jonna Capezzuto, Office of Information
Management , Food and Drug Administration, 1350 Piccard Dr., P150-400B
Rockville, MD 20850, 301-796-3794, JonnaLynn.Capezzuto@fda.hhs.gov.
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.
National Consumer Surveys on Understanding the Risks and Benefits of
FDA-Regulated Medical Products
Risks and benefits are inherent in all FDA-regulated medical
products, including drugs, biologics, and medical devices (e.g.,
pacemakers, implantable cardiac defibrillators, contact lenses,
infusion pumps). FDA plays a critical oversight role in managing and
preventing injuries and deaths related to medical product use. However,
the users of FDA-regulated products are ultimately the ones who
determine which products are used and how they are potentially misused.
For this reason, it is critical that the public understand the risks
and benefits of FDA-regulated medical products to a degree that allows
them to make rational decisions about product use.
FDA's responsibility includes communicating about medical products.
This encompasses communications that FDA generates and those it
oversees through regulation of product manufacturers' and distributors'
communications. Activities include, but are not limited to, recall
notices, warnings, public health advisories and notifications, press
releases, and information made available on its Web site. FDA also
regulates communications drafted and disseminated by manufacturers and
distributors of many medical products, including all the communications
(advertising and labeling) about prescription drugs, biologics, and
restricted medical devices, and a subset of communications (omitting
advertising) about nonprescription drugs and other medical devices. In
order to conduct educational and public information programs relating
to these responsibilities, as authorized by Section 1003(d)(2)(D) of
the Federal Food Drug and Cosmetic Act (21 U.S.C. section 393), it is
beneficial for FDA to conduct research and studies relating to health
information as authorized by section 1701(a)(4) of the Public Health
Service Act (42 U.S.C. 300u(a)(4)).
In conducting such research, FDA will employ nationally
representative surveys of consumers to assess whether the information
being disseminated by both the agency and the entities it regulates is
appropriately reaching targeted audiences in an understandable fashion.
Specifically, the surveys will assess public understanding about the
benefits and risks of medical products and FDA's role in regulating
these products. The surveys will assess behaviors and beliefs related
to the use of medical products, when consumers desire emerging risk
information, the likelihood of reporting serious side effects that
might be associated with medical product use, perceptions of the
credibility of FDA and other potential sources of risk and benefit
information, and satisfaction with FDA's communications-related
performance.
Parallel surveys of 1,500 non-institutionalized U.S. adults will be
administered. One survey of 1,500 subjects will be a telephone survey,
and the second survey of another 1,500 subjects will be conducted with
members from an Internet panel. Both survey samples will be constructed
to be representative of the U.S. population, and both will take
approximately 15 minutes to administer. Results from each survey will
be compared to provide insight into the best methodology for future
studies.
The information collected will be used by FDA in the development of
more effective risk communication strategies and messages. The surveys
will provide FDA insight as to how well the public understands and
incorporates risk/benefit information into their belief structures, and
how well the public understands the context within which FDA makes
decisions on medical product recalls and warnings. Using this
information, the agency will more effectively design messages and
select formats and distribution channels that have the greatest
potential to influence the target audience's attitudes and behavior in
a favorable way. Frequency of Response: On occasion. Affected Public:
Individuals or households; Type of Respondents: Members of the public.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Type of Response Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretests 30 1 30 0.25 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 61492]]
Screener 6,700 1 6,700 0.10 670
--------------------------------------------------------------------------------------------------------------------------------------------------------
Telephone survey 1,500 1 1,500 0.25 375
--------------------------------------------------------------------------------------------------------------------------------------------------------
Internet panel survey 1,500 1 1,500 0.25 375
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 1,428
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on FDA's and the contractor's experience
with previous surveys. Prior to administering the surveys with the
entire sample, FDA plans to conduct pretests with up to 30 adults;
these are meant to evaluate the effectiveness of the programming of the
interview protocol, online filters, and skip patterns.
Dated: September 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-25007 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S
