Proposed Collection; Comment Request; Testing Successful Health Communications Surrounding Aging-Related Issues From the National Institute on Aging (NIA), 59723-59724 [2010-24277]
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Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices
questions are covered in this guidance:
(1) What types of industry-initiated
actions are subject to a claim of
categorical exclusion? (2) what must a
claim of categorical exclusion include
by regulation? (3) what is an EA? (4)
when is an EA required by regulation
and what format should be used? (5)
what are extraordinary circumstances?
and (6) what suggestions does CFSAN
have for preparing an EA? Although
CFSAN encourages industry to use the
EA formats described in the guidance
because standardized documentation
submitted by industry increases the
efficiency of the review process,
alternative approaches may be used if
these approaches satisfy the
requirements of the applicable statutes
and regulations. FDA is requesting the
extension of OMB approval for the
information collection provisions in the
guidance. The likely respondents
include businesses engaged in the
manufacture or sale of food, food
ingredients, and substances used in
materials that come into contact with
food.
In the Federal Register of July 21,
2010 (75 FR 42446), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. In response, the agency
received one comment that was not
responsive to the comment request on
the information collection provisions.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
25.32(i)
34
1
34
1
34
25.32(o)
1
1
1
1
1
25.32(q)
2
1
2
1
2
Total
srobinson on DSKHWCL6B1PROD with NOTICES
1 There
37
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimates for respondents and
numbers of responses are based on the
annualized numbers of petitions and
notifications qualifying for § 25.32(i)
and (q) that the agency has received in
the past 3 years. Please note that, in the
past 3 years, there have been no
submissions that requested an action
that would have been subject to the
categorical exclusion in § 25.32(o). To
avoid counting this burden as zero, FDA
has estimated the burden for this
categorical exclusion at one respondent
making one submission a year for a total
of one annual submission.
To calculate the estimate for the hours
per response values, we assumed that
the information requested in this
guidance for each of these three
categorical exclusions is readily
available to the submitter. For the
information requested for the exclusion
in § 25.32(i), we expect that the
submitter will need to gather
information from appropriate persons in
the submitter’s company and to prepare
this information for attachment to the
claim for categorical exclusion. We
believe that this effort should take no
longer than 1 hour per submission. For
the information requested for the
exclusions in § 25.32(o) and (q), the
submitters will almost always merely
need to copy existing documentation
and attach it to the claim for categorical
exclusion. We believe that collecting
this information should also take no
longer than 1 hour per submission.
VerDate Mar<15>2010
15:22 Sep 27, 2010
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Dated: September 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–24272 Filed 9–27–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Testing Successful Health
Communications Surrounding AgingRelated Issues From the National
Institute on Aging (NIA)
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
National Institute on Aging, the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: Testing
successful health communications
surrounding aging-related issues from
the National Institute on Aging (NIA).
Type of Information Collection Request:
New. Need and Use of Information
Collection: This study will support
NIA’s mission ‘‘to communicate
information about aging and advances
in research on aging to the scientific
community, health care providers, and
SUMMARY:
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Fmt 4703
Sfmt 4703
the public.’’ The primary objectives of
this study are to:
• Assess audiences’ trusted/preferred
sources for information, knowledge,
attitudes, behaviors, and other
characteristics for the planning/
development of health messages and
communications strategies;
• Pre-test health messages and
outreach strategies while they are in
developmental form to assess audience
response, including their likes and
dislikes.
NIA’s Office of Communications and
Public liaison will collect this
information through formative
qualitative research with its key
audiences—older people, caregivers,
and health professionals. Methods will
include focus groups, individual
interviews, self-administered
questionnaires, and website surveys.
The information will be used to (1)
Develop and revise health information
resources and outreach strategies to
maximize their effectiveness; (2)
determine new topic areas to explore for
future NIA publications; and (3) identify
new ways to support the health
information needs of older adults and
people who serve older adults. NIA is
requesting a generic clearance for a
range of research data collection
procedures to ensure that they
successfully develop and disseminate
effective health communications on
aging-related issues. Frequency of
Response: On occasion. Affected Public:
Older people, caregivers, and health
professionals (physicians and nonphysicians). Type of Respondents: Older
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Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices
people, caregivers, and health
professionals (physicians and nonphysicians). The annual reporting
burden is as follows: Estimated Number
of Respondents: 630. Estimated Number
of Responses per Respondent: 1.
Average Burden Hours Per Response:
0.37. Estimated Total Annual Burden
Hours Requested: 234. The annualized
cost to respondents is estimated at:
Estimated
number of
respondents
Type of respondents
$5,680. There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
Estimated
number of
responses per
respondent
Average burden
hours per
response
Estimated total
annual burden
hours
requested
Older adults ...................................................................................................
Non-physician health professionals and caregivers ......................................
Physicians ......................................................................................................
260
310
60
1
1
1
.37
.35
.5
97
107
30
Total ........................................................................................................
........................
........................
..........................
234
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Megan Homer,
Writer/Editor, Office of
Communications and Public Liaison,
NIH, Building 31C Room 5C27, 9000
Rockville Pike, Bethesda, MD 20892, or
call non-toll-free number 301–496–1752
or E-mail your request, including your
address to: homerm@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
srobinson on DSKHWCL6B1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Dated: September 22, 2010.
Lynn Hellinger,
Director of Management, National Institutes
of Health.
[FR Doc. 2010–24277 Filed 9–27–10; 8:45 am]
BILLING CODE 4140–01–P
VerDate Mar<15>2010
15:22 Sep 27, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Transfusion-Transmitted
Retrovirus and Hepatitis Virus Rates
and Risk Factors: Improving the Safety
of the U.S. Blood Supply Through
Hemovigilance
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
National Heart, Lung, and Blood
Institute (NHLBI), the National
Institutes of Health (NIH), will publish
periodic summaries of proposed
projects to the Office of Management
and Budget (OMB) for review and
approval.
Proposed Collection: Title:
Transfusion-transmitted retrovirus and
hepatitis virus rates and risk factors:
Improving the safety of the U.S. blood
supply through hemovigilance. Type of
Information Collection Request: NEW.
Need and Use of Information Collection:
Information on current risk factors in
blood donors as assessed using
analytical study designs is largely
unavailable in the U.S. Studies of risk
factor profiles among HIV-infected
donors were funded by the CDC for
approximately 10 years after
implementation of serologic screening
in the mid-1980s, whereas studies of
HTLV- and HCV-seropositive (and
indeterminate) donors, funded by NIH,
were conducted in the early 1990s, but
unfortunately, none of these studies is
ongoing. Infection trend analyses have
been conducted by the American Red
Cross (ARC). The findings show
continued HIV risk with the prevalence
of HIV in first time donors hovering
around 10 per 100,000 donations in
each of the last 10 years and the
incidence in repeat donors increasing
SUMMARY:
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from 1.49 per 100,000 person-years in
1999–2000 to 2.16 per 100,000 personsyears in 2007–2008. While the
prevalence of HCV in first time donors
decreased over this time interval from
345 to 163 per 100,000 donations, the
incidence in repeat donors did not
decrease and evidence of incident
infection in first time donors increased.
Moreover specific age, gender and race/
ethnicity groups were over-represented.
Significantly increased incidence of
both HIV and HCV were observed in
2007/2008 compared to 2005/2006.
Similar analyses for HBV have shown
an incidence in all donors of 3.4 per
100,000 person-years which is lower
than earlier estimates, but remains
higher than for HIV and HCV.
This project represents a collaborative
pilot research study that will include a
comprehensive interview study of viral
infection positive blood donors at the
American Red Cross (ARC), Blood
Systems Inc. (BSI) and New York Blood
Center (NYBC) in order to identify the
current predominant risk factors for
virus positive donations and will also
establish a donor biovigilance capacity
that currently does not exist in the U.S.
At this time it is not easy to integrate
risk factor data and disease marker
surveillance information within or
across different blood collection
organizations because common
interview procedures and laboratory
confirmation procedures are not being
used and so we cannot easily tabulate
and analyze behavioral risks or viral
infections in U.S. blood donors. This
creates the potential for gaps in our
understanding of absolute incidence
and prevalence as well as risks that
could lead to transfusion-transmitted
disease. Combined data are critical for
appropriate national surveillance
efforts. For example, this information
could be used to target educational
interventions to reduce donations from
persons with high risk behaviors. This
is particularly important in the case of
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[Federal Register Volume 75, Number 187 (Tuesday, September 28, 2010)]
[Notices]
[Pages 59723-59724]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24277]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Testing Successful Health
Communications Surrounding Aging-Related Issues From the National
Institute on Aging (NIA)
SUMMARY: 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 National Institute on Aging,
the National Institutes of Health (NIH) will publish periodic summaries
of proposed projects to be submitted to the Office of Management and
Budget (OMB) for review and approval.
Proposed Collection: Title: Testing successful health
communications surrounding aging-related issues from the National
Institute on Aging (NIA). Type of Information Collection Request: New.
Need and Use of Information Collection: This study will support NIA's
mission ``to communicate information about aging and advances in
research on aging to the scientific community, health care providers,
and the public.'' The primary objectives of this study are to:
Assess audiences' trusted/preferred sources for
information, knowledge, attitudes, behaviors, and other characteristics
for the planning/development of health messages and communications
strategies;
Pre-test health messages and outreach strategies while
they are in developmental form to assess audience response, including
their likes and dislikes.
NIA's Office of Communications and Public liaison will collect this
information through formative qualitative research with its key
audiences--older people, caregivers, and health professionals. Methods
will include focus groups, individual interviews, self-administered
questionnaires, and website surveys. The information will be used to
(1) Develop and revise health information resources and outreach
strategies to maximize their effectiveness; (2) determine new topic
areas to explore for future NIA publications; and (3) identify new ways
to support the health information needs of older adults and people who
serve older adults. NIA is requesting a generic clearance for a range
of research data collection procedures to ensure that they successfully
develop and disseminate effective health communications on aging-
related issues. Frequency of Response: On occasion. Affected Public:
Older people, caregivers, and health professionals (physicians and non-
physicians). Type of Respondents: Older
[[Page 59724]]
people, caregivers, and health professionals (physicians and non-
physicians). The annual reporting burden is as follows: Estimated
Number of Respondents: 630. Estimated Number of Responses per
Respondent: 1. Average Burden Hours Per Response: 0.37. Estimated Total
Annual Burden Hours Requested: 234. The annualized cost to respondents
is estimated at: $5,680. There are no Capital Costs to report. There
are no Operating or Maintenance Costs to report.
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average burden total annual
Type of respondents number of responses per hours per burden hours
respondents respondent response requested
----------------------------------------------------------------------------------------------------------------
Older adults.................................... 260 1 .37 97
Non-physician health professionals and 310 1 .35 107
caregivers.....................................
Physicians...................................... 60 1 .5 30
---------------------------------------------------------------
Total....................................... .............. .............. .............. 234
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) Evaluate the accuracy of the agency's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Megan Homer, Writer/Editor, Office of
Communications and Public Liaison, NIH, Building 31C Room 5C27, 9000
Rockville Pike, Bethesda, MD 20892, or call non-toll-free number 301-
496-1752 or E-mail your request, including your address to:
homerm@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Dated: September 22, 2010.
Lynn Hellinger,
Director of Management, National Institutes of Health.
[FR Doc. 2010-24277 Filed 9-27-10; 8:45 am]
BILLING CODE 4140-01-P
