Proposed Data Collections Submitted for Public Comment and Recommendations, 47598-47599 [2010-19396]
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47598
Federal Register / Vol. 75, No. 151 / Friday, August 6, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Nomination for
Appointment to the Advisory
Committee on Minority Health;
Correction
launched Act Against AIDS, a 5-year,
multifaceted communication campaign
to reduce HIV incidence in the United
States. CDC plans to release the
campaign in phases, with some of the
phases running concurrently. Each
phase of the campaign will use mass
media and direct-to-consumer channels
to deliver HIV prevention and testing
messages. Some components of the
campaign will be designed to provide
basic education and increase awareness
of HIV/AIDS among the general public,
and others will be targeted to specific
subgroups or communities at greatest
risk of infection. The current study
addresses the need to assess the
effectiveness of these social marketing
messages aimed at increasing HIV
awareness and delivering HIV
prevention and testing messages among
at-risk populations.
This study will evaluate the Act
Against AIDS (AAA) social marketing
campaign aimed at increasing HIV/AIDS
awareness, increasing prevention
behaviors, and improving HIV testing
rates among consumers. The study will
consist of a quarterly tracking survey of
AAA target audiences to measure
exposure to each phase of the campaign
and interventions implemented under
AAA. Each extended survey will have a
core set of items asked in all rounds, as
well as a module of questions relating
to specific AAA activities and
communication initiatives that are
occurring during a given quarter. Each
extended survey sample will consist of
1,000 respondents selected from a
combination of sources, including a
national opt-in e-mail list sample and
respondent lists generated by
partnership organizations (e.g., the
National Urban League, the National
Medical Association). Participants will
self-administer the extended survey at
home on personal computers. The
research will include 12 data collections
over a 3-year period: Four selfadministered quarterly extended
surveys per year over 3 years, with a
total of 12,000 respondents. There is no
cost to the respondents other than their
time.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–10–10GI]
Department of Health and
Human Services, Office of the Secretary,
Office of Public Health and Science,
Office of Minority Health.
AGENCY:
ACTION:
Notice: Correction.
The Department of Health and
Human Services published a document
in the Federal Register on Thursday,
July 22, 2010 soliciting nominations for
appointment to the Advisory Committee
on Minority Health. Within the FOR
FURTHER INFORMATION CONTACT section,
there was a typographical error in the
Web site address managed by the Office
of Minority Health.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Ms.
Monica Baltimore, (240) 453–2882.
Correction
In the Federal Register of July 22,
2010, Vol. 75, No. 140, page 42754, in
the second column, correct the FOR
FURTHER INFORMATION CONTACT section to
read: Ms. Monica Baltimore, Executive
Director, Advisory Committee on
Minority Health, Office of Minority
Health, Office of Public Health and
Science, Department of Health and
Human Services, 1101 Wootton
Parkway, Suite 600, Rockville, MD
20852; Telephone: (240) 453–2882. A
copy of the Committee charter and list
of the current membership can be
obtained by contacting Ms. Baltimore or
by accessing the Web site managed by
OMH at https://
www.minorityhealth.hhs.gov/acmh.
Dated: July 28, 2010.
Garth N. Graham,
Deputy Assistant Secretary for Minority
Health.
[FR Doc. 2010–19409 Filed 8–5–10; 8:45 am]
BILLING CODE 4150–29–P
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Maryam I. Daneshvar,
CDC Reports Clearance Officer, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an e-mail to
omb@cdc.gov.
Comments are invited 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
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance 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. Written comments should
be received within 60 days of this
notice.
Proposed Project
Evaluating Act Against AIDS Social
Marketing Campaign Phases Targeting
Consumers—New—National Center for
HIV/AIDS, Viral Hepatitis, STD and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
In response to the continued HIV
epidemic in our country, CDC has
sroberts on DSKD5P82C1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Total
burden
(in hours)
Data collection
type
Individuals (male and female) aged 18 years and older
Individuals (male and female) aged 18 years and older
Study Screener ....
Extended survey ..
20,000
4,000
1
1
2/60
30/60
667
2,000
Total ........................................................................
..............................
........................
........................
........................
2,667
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Number of
respondents
Number of
responses per
respondent
Respondents
Sfmt 4703
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06AUN1
Federal Register / Vol. 75, No. 151 / Friday, August 6, 2010 / Notices
Dated: August 2, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2010–19396 Filed 8–5–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0380]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Food and
Drug Administration Rapid Response
Surveys
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, 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
the use of rapid response surveys to
obtain data on safety information to
support quick-turnaround
decisionmaking about potential safety
problems or risk management solutions
from health care professionals, hospitals
and other user-facilities (e.g., nursing
homes, etc.); consumers; manufacturers
of biologics, drugs, and medical devices;
distributors; and importers when FDA
must quickly determine whether or not
a problem with a biologic, drug, or
medical device impacts the public
health.
DATES: Submit either electronic or
written comments on the collection of
information by October 5, 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.
sroberts on DSKD5P82C1PROD with NOTICES
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
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,
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.
Generic Food and Drug Administration
Rapid Response Surveys—(OMB
Control Number 0910–0500)—Extension
Section 505 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355), requires that important safety
information relating to all human
prescription drug products be made
available to FDA so that it can take
appropriate action to protect the public
health when necessary. Section 702 of
the act (21 U.S.C. 372) authorizes
investigational powers to FDA for
enforcement of the act. Under section
519 of the act (21 U.S.C. 360i), FDA is
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Frm 00077
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47599
authorized to require manufacturers to
report medical device-related deaths,
serious injuries, and malfunctions to
FDA; to require user facilities to report
device-related deaths directly to FDA
and to manufacturers; and to report
serious injuries to the manufacturer.
Section 522 of the act (21 U.S.C. 360l)
authorizes FDA to require
manufacturers to conduct postmarket
surveillance of medical devices. Section
705(b) of the act (21 U.S.C. 375(b))
authorizes FDA to collect and
disseminate information regarding
medical products or cosmetics in
situations involving imminent danger to
health or gross deception of the
consumer. Section 903(d)(2) of the act
(21 U.S.C. 393(d)(2)) authorizes the
Commissioner of Food and Drugs to
implement general powers (including
conducting research) to carry out
effectively the mission of FDA. These
sections of the act enable FDA to
enhance consumer protection from risks
associated with medical products usage
that are not foreseen or apparent during
the premarket notification and review
process. FDA’s regulations governing
application for agency approval to
market a new drug (21 CFR part 314)
and regulations governing biological
products (21 CFR part 600) implement
these statutory provisions. Currently
FDA monitors medical product related
postmarket adverse events via both the
mandatory and voluntary MedWatch
reporting systems using FDA Forms
3500 and 3500A (OMB control number
0910–0291) and the vaccine adverse
event reporting system. FDA is seeking
OMB clearance to collect vital
information via a series of rapid
response surveys. Participation in these
surveys will be voluntary. This request
covers rapid response surveys for
community based health care
professionals, general type medical
facilities, specialized medical facilities
(those known for cardiac surgery,
obstetrics/gynecology services, pediatric
services, etc.), other health care
professionals, patients, consumers, and
risk managers working in medical
facilities. FDA will use the information
gathered from these surveys to obtain
quickly vital information about medical
product risks and interventions to
reduce risks so the agency may take
appropriate public health or regulatory
action including dissemination of this
information as necessary and
appropriate.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\06AUN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 151 (Friday, August 6, 2010)]
[Notices]
[Pages 47598-47599]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19396]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-10-10GI]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960
and send comments to Maryam I. Daneshvar, CDC Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
Comments are invited 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 agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance 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. Written comments should be received
within 60 days of this notice.
Proposed Project
Evaluating Act Against AIDS Social Marketing Campaign Phases
Targeting Consumers--New--National Center for HIV/AIDS, Viral
Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
In response to the continued HIV epidemic in our country, CDC has
launched Act Against AIDS, a 5-year, multifaceted communication
campaign to reduce HIV incidence in the United States. CDC plans to
release the campaign in phases, with some of the phases running
concurrently. Each phase of the campaign will use mass media and
direct-to-consumer channels to deliver HIV prevention and testing
messages. Some components of the campaign will be designed to provide
basic education and increase awareness of HIV/AIDS among the general
public, and others will be targeted to specific subgroups or
communities at greatest risk of infection. The current study addresses
the need to assess the effectiveness of these social marketing messages
aimed at increasing HIV awareness and delivering HIV prevention and
testing messages among at-risk populations.
This study will evaluate the Act Against AIDS (AAA) social
marketing campaign aimed at increasing HIV/AIDS awareness, increasing
prevention behaviors, and improving HIV testing rates among consumers.
The study will consist of a quarterly tracking survey of AAA target
audiences to measure exposure to each phase of the campaign and
interventions implemented under AAA. Each extended survey will have a
core set of items asked in all rounds, as well as a module of questions
relating to specific AAA activities and communication initiatives that
are occurring during a given quarter. Each extended survey sample will
consist of 1,000 respondents selected from a combination of sources,
including a national opt-in e-mail list sample and respondent lists
generated by partnership organizations (e.g., the National Urban
League, the National Medical Association). Participants will self-
administer the extended survey at home on personal computers. The
research will include 12 data collections over a 3-year period: Four
self-administered quarterly extended surveys per year over 3 years,
with a total of 12,000 respondents. There is no cost to the respondents
other than their time.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Data collection type Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Individuals (male and female) aged 18 years and older Study Screener................... 20,000 1 2/60 667
Individuals (male and female) aged 18 years and older Extended survey.................. 4,000 1 30/60 2,000
---------------------------------------------------------------
Total............................................ ................................. .............. .............. .............. 2,667
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 47599]]
Dated: August 2, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2010-19396 Filed 8-5-10; 8:45 am]
BILLING CODE 4163-18-P
