Proposed Data Collections Submitted for Public Comment and Recommendations, 37449-37450 [2010-15780]
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37449
Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Notices
Written comments and
recommendations concerning the
proposed information collection should
be sent by July 29, 2010 to: SAMHSA
Desk Officer, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503; due to potential delays in OMB’s
receipt and processing of mail sent
through the U.S. Postal Service,
respondents are encouraged to submit
comments by fax to: 202–395–5806.
Dated: June 22, 2010.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. 2010–15721 Filed 6–28–10; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–10–10FB]
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,
Ph.D., 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
Developing a Sexual consent Norms
Instrument—New—National Center for
Injury Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Sexual violence prevention strategies
are increasingly focusing on promoting
positive behavioral norms such as
safety, equality and respect in
relationships, however
psychometrically validated measures do
not exist for programs to use in
evaluating their strategies. This project
provides an opportunity to significantly
contribute to the literature base and fill
a gap in evaluation tools by developing
a measure specific to consent norms for
use in three populations: college
students, late adolescents (ages 15–18)
and early adolescents (ages 11–14).
Sound measures of sexual consent
norms will improve program evaluation
efforts and potentially contribute to
understanding of effective prevention
strategies as well as the etiology of
sexual violence perpetration.
The development of these measures
will occur in four phases. Phase one
will consist of multiple two-hour focus
groups of 8–10 participants: 1 with
prevention educators, 8 with college
students, 8 with late adolescents (ages
15–18) and 8 with early adolescents
(ages 11–14). Samples of college
students and adolescents will include
Asian, Black and African American,
Hispanic or Latino, and White students.
Half of the college student focus groups
will be conducted with students who
grew up in the United States; the other
half will be conducted with students
who came to the United States within
the last five years. Focus group
participants will be asked to comment
on the proposed instruments relevant to
their group. Prevention educators will
comment on all three instruments.
Comments will be used to refine the
measures.
In phase two, 200 Asian, Black and
African American, Hispanic or Latino,
and White college students and 100
Asian, Black and African American,
Hispanic or Latino, and White
adolescents will complete the revised
instrument appropriate to age group,
plus a set of existing instruments that
assess related variables, using online
data collection methods.
Phase three will consist of multiple
two-hour focus groups of 8–10
participants: 2 with prevention
educators, 1 with college students, 1
with late adolescents (ages 15–18) and
1 with early adolescents (ages 11–14).
Samples of college students and
adolescents will include Asian, Black
and African American, Hispanic or
Latino, and White students as well as
students who grew up in the United
States and students who came to the
United States in the last five years. All
focus group participants will be asked to
comment on data collected with the
revised instruments in their age group.
Prevention educators will be asked to
comment on data from all age groups.
Comments will be used to refine the
instrument again, before administering
it to larger samples.
In phase four, the refined instruments
plus a set of existing instruments that
assess related variables will be
administered to 500 Asian, Black and
African American, Hispanic or Latino,
and White college students and 400
Asian, Black and African American,
Hispanic or Latino, and White
adolescents (200 early adolescents and
200 late adolescents). Data collection
will occur via an online survey. These
data will be used to examine the
psychometric properties of the new
instruments.
Findings will be used to demonstrate
the adequacy of new instruments for use
in racially and ethnically diverse
populations of college student and
adolescents by sexual assault prevention
programs funded through the Rape
Prevention and Education Program.
There is no cost to respondents other
than their time.
emcdonald on DSK2BSOYB1PROD with NOTICES4
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents/form name
Phase
Phase
Phase
Phase
I:
I:
I:
I:
Focus
Focus
Focus
Focus
VerDate Mar<15>2010
Group
Group
Group
Group
of
of
of
of
Prevention Educators ............................................
College Students ...................................................
Late Adolescents ..................................................
Early Adolescents .................................................
19:55 Jun 28, 2010
Jkt 220001
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
Number of responses per
respondent
10
10
10
10
E:\FR\FM\29JNN1.SGM
1
1
1
1
29JNN1
Average
burden per
response
(hours)
3
2.5
3
3
Total burden
(in hrs)
30
25
30
30
37450
Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Respondents/form name
Phase
Phase
Phase
Phase
Phase
Phase
Phase
Phase
Phase
Phase
Average
burden per
response
(hours)
Number of responses per
respondent
Total burden
(in hrs)
II: College Student Survey .................................................................
II: Late Adolescent Survey .................................................................
II: Early Adolescent Survey ................................................................
III: Follow-up Focus Group of Prevention Educators .........................
III: Follow-up Focus Group of College Students ................................
III: Follow-up Focus Group of Late Adolescents ................................
III: Follow-up Focus Group of Early Adolescents ..............................
IV: Confirmatory Survey of College Students ....................................
IV: Confirmatory Survey of Late Adolescents ....................................
IV: Confirmatory Survey of Early Adolescents ...................................
200
50
50
20
10
10
10
500
200
200
1
1
1
1
1
1
1
1
1
1
2
2
1
3
2.5
3
3
2
2
1
400
100
50
60
25
30
30
1000
400
200
Total ........................................................................................................
........................
........................
..........................
2410
Dated: June 23, 2010.
Carol Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–15780 Filed 6–28–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0094]
Draft Guidance: The Judicious Use of
Medically Important Antimicrobial
Drugs in Food-Producing Animals;
Availability
AGENCY:
Food and Drug Administration,
HHS.
emcdonald on DSK2BSOYB1PROD with NOTICES4
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance (#209)
entitled ‘‘The Judicious Use of Medically
Important Antimicrobial Drugs in FoodProducing Animals.’’ This draft
guidance is intended to inform the
public of FDA’s current thinking on the
use of medically important
antimicrobial drugs in food-producing
animals.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by August 30,
2010.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one self-
VerDate Mar<15>2010
19:55 Jun 28, 2010
Jkt 220001
addressed adhesive label to assist that
office in processing your requests.
Additional copies of this guidance are
available from the Office of
Communication, Outreach and
Development (OCOD) (HFM–40), Food
and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, or by calling 1–800–
835–4709 or 301–827–1800, or e-mail:
ocod@fda.hhs.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments on the draft guidance to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
William T. Flynn, Center for Veterinary
Medicine (HFV–1), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9084, email: william.flynn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance (#209) entitled ‘‘The
Judicious Use of Medically Important
Antimicrobial Drugs in Food-Producing
Animals.’’ Antimicrobial drugs have
been widely used in human and
veterinary medicine for more than 50
years, with tremendous benefits to both
human and animal health. The
development of resistance to this
important class of drugs, and the
resulting loss of their effectiveness as
antimicrobial therapies, poses a serious
public health threat. Misuse and
overuse of antimicrobial drugs creates
selective evolutionary pressure that
enables antimicrobial resistant bacteria
to increase in numbers more rapidly
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
than antimicrobial susceptible bacteria
and thus increases the opportunity for
individuals to become infected by
resistant bacteria. Because antimicrobial
drug use contributes to the emergence of
drug resistant organisms, these
important drugs must be used
judiciously in both animal and human
medicine to slow the development of
resistance. Using these drugs
judiciously means that unnecessary or
inappropriate use should be avoided.
Although efforts to assure judicious use
should be directed at all uses of
antimicrobial drugs, the focus of this
document is on the use of medically
important antimicrobial drugs in foodproducing animals.
In regard to the use of antimicrobial
drugs in animals, concerns have been
raised by the public and components of
the scientific and public health
communities that a significant
contributing factor to antimicrobial
resistance is the use of medically
important antimicrobial drugs in foodproducing animals for production or
growth-enhancing purposes. This
document summarizes some of the key
scientific reports on the use of
antimicrobial drugs in animal
agriculture and outlines FDA’s current
thinking on strategies for assuring that
medically important antimicrobial drugs
are used judiciously in food-producing
animals in order to help minimize
antimicrobial resistance development.
Based on a consideration of the
available scientific information, FDA is
making a number of recommendations
regarding the appropriate or judicious
use of medically important
antimicrobial drugs in food-producing
animals. These recommendations
include phasing in such measures as
follows: (1) Limiting medically
important antimicrobial drugs to uses in
food-producing animals that are
considered necessary for assuring
E:\FR\FM\29JNN1.SGM
29JNN1
]]>Agencies
[Federal Register Volume 75, Number 124 (Tuesday, June 29, 2010)]
[Notices]
[Pages 37449-37450]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15780]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-10-10FB]
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, Ph.D., 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
Developing a Sexual consent Norms Instrument--New--National Center
for Injury Prevention and Control (NCIPC), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Sexual violence prevention strategies are increasingly focusing on
promoting positive behavioral norms such as safety, equality and
respect in relationships, however psychometrically validated measures
do not exist for programs to use in evaluating their strategies. This
project provides an opportunity to significantly contribute to the
literature base and fill a gap in evaluation tools by developing a
measure specific to consent norms for use in three populations: college
students, late adolescents (ages 15-18) and early adolescents (ages 11-
14). Sound measures of sexual consent norms will improve program
evaluation efforts and potentially contribute to understanding of
effective prevention strategies as well as the etiology of sexual
violence perpetration.
The development of these measures will occur in four phases. Phase
one will consist of multiple two-hour focus groups of 8-10
participants: 1 with prevention educators, 8 with college students, 8
with late adolescents (ages 15-18) and 8 with early adolescents (ages
11-14). Samples of college students and adolescents will include Asian,
Black and African American, Hispanic or Latino, and White students.
Half of the college student focus groups will be conducted with
students who grew up in the United States; the other half will be
conducted with students who came to the United States within the last
five years. Focus group participants will be asked to comment on the
proposed instruments relevant to their group. Prevention educators will
comment on all three instruments. Comments will be used to refine the
measures.
In phase two, 200 Asian, Black and African American, Hispanic or
Latino, and White college students and 100 Asian, Black and African
American, Hispanic or Latino, and White adolescents will complete the
revised instrument appropriate to age group, plus a set of existing
instruments that assess related variables, using online data collection
methods.
Phase three will consist of multiple two-hour focus groups of 8-10
participants: 2 with prevention educators, 1 with college students, 1
with late adolescents (ages 15-18) and 1 with early adolescents (ages
11-14). Samples of college students and adolescents will include Asian,
Black and African American, Hispanic or Latino, and White students as
well as students who grew up in the United States and students who came
to the United States in the last five years. All focus group
participants will be asked to comment on data collected with the
revised instruments in their age group. Prevention educators will be
asked to comment on data from all age groups. Comments will be used to
refine the instrument again, before administering it to larger samples.
In phase four, the refined instruments plus a set of existing
instruments that assess related variables will be administered to 500
Asian, Black and African American, Hispanic or Latino, and White
college students and 400 Asian, Black and African American, Hispanic or
Latino, and White adolescents (200 early adolescents and 200 late
adolescents). Data collection will occur via an online survey. These
data will be used to examine the psychometric properties of the new
instruments.
Findings will be used to demonstrate the adequacy of new
instruments for use in racially and ethnically diverse populations of
college student and adolescents by sexual assault prevention programs
funded through the Rape Prevention and Education Program. There is no
cost to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents/form name Number of responses per per response Total burden
respondents respondent (hours) (in hrs)
----------------------------------------------------------------------------------------------------------------
Phase I: Focus Group of Prevention Educators... 10 1 3 30
Phase I: Focus Group of College Students....... 10 1 2.5 25
Phase I: Focus Group of Late Adolescents....... 10 1 3 30
Phase I: Focus Group of Early Adolescents...... 10 1 3 30
[[Page 37450]]
Phase II: College Student Survey............... 200 1 2 400
Phase II: Late Adolescent Survey............... 50 1 2 100
Phase II: Early Adolescent Survey.............. 50 1 1 50
Phase III: Follow-up Focus Group of Prevention 20 1 3 60
Educators.....................................
Phase III: Follow-up Focus Group of College 10 1 2.5 25
Students......................................
Phase III: Follow-up Focus Group of Late 10 1 3 30
Adolescents...................................
Phase III: Follow-up Focus Group of Early 10 1 3 30
Adolescents...................................
Phase IV: Confirmatory Survey of College 500 1 2 1000
Students......................................
Phase IV: Confirmatory Survey of Late 200 1 2 400
Adolescents...................................
Phase IV: Confirmatory Survey of Early 200 1 1 200
Adolescents...................................
----------------------------------------------------------------
Total..................................... .............. .............. ............... 2410
----------------------------------------------------------------------------------------------------------------
Dated: June 23, 2010.
Carol Walker,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2010-15780 Filed 6-28-10; 8:45 am]
BILLING CODE 4163-18-P
