Agency Forms Undergoing Paperwork Reduction Act Review, 6205-6206 [2010-2600]
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6205
Federal Register / Vol. 75, No. 25 / Monday, February 8, 2010 / Notices
Dated: February 3, 2010.
Karen V. Gregory,
Secretary.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[FR Doc. 2010–2705 Filed 2–5–10; 8:45 am]
BILLING CODE 6730–01–P
[30Day–10–0747]
FEDERAL MARITIME COMMISSION
Agency Forms Undergoing Paperwork
Reduction Act Review
Sunshine Act Meetings
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call Maryam I. Daneshvar, the
CDC Reports Clearance Officer, at (404)
639–5960 or send an e-mail to
omb@cdc.gov. Send written comments
to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
TIME AND DATE:
February 10, 2010—10
a.m.
PLACE: 800 North Capitol Street, NW.,
First Floor Hearing Room, Washington,
DC.
STATUS: The meeting will be in Open
Session.
MATTERS TO BE CONSIDERED:
Open Session
1. Docket No. 06–01: Worldwide
Relocations, Inc.; et al.,—Possible
Violations of Sections 8, 10, and 19 of
the Shipping Act of 1984 and the
Commission’s Regulations at 46 CFR
515.3, 515.21, and 520.3—Request for
Extension of Time.
2. Docket No. 08–04: Tienshan, Inc. v.
Tianjin Hua Feng Transport Agency Co.,
Ltd—Request for Extension of Time.
3. FY 2010 Budget Status Update.
4. Petition P1–08—Petition of the
National Customs Brokers and
Forwarders Association of America, Inc.
for Exemption from Mandatory Rate
Tariff Publication.
CONTACT PERSON FOR MORE INFORMATION:
Karen V. Gregory, Secretary, (202) 523–
5725.
Karen V. Gregory,
Secretary.
[FR Doc. 2010–2616 Filed 2–4–10; 4:15 pm]
BILLING CODE P
Proposed Project
Longitudinal follow-up of Youth with
Attention-Deficit/Hyperactivity Disorder
identified in Community Settings:
Examining Health Status, Correlates,
and Effects associated with treatment for
ADHD (OMB #0920–0747, exp. 7/31/
2010)—Revision—National Center on
Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
This project will collect data from
proxy respondents and youths with and
without Attention-Deficit/Hyperactivity
Disorder (ADHD). This program
addresses the Healthy People 2010 focus
area of Mental Health and Mental
Disorders, and describes the prevalence,
incidence, long-term outcomes,
treatment(s), select co-morbid
conditions, secondary conditions, and
health risk behavior of youth with
ADHD relative to youth without ADHD.
The National Center on Birth Defects
and Developmental Disabilities at CDC
promotes the health of children with
developmental disorders. As part of
these efforts, two contracts were
awarded in FY 2007–2010 to follow up
a sample of children originally enrolled
in community-based epidemiological
research on ADHD among elementaryaged youth, known as the Project to
Learn about ADHD in Youth (PLAY
Study Collaborative), which informed
community-based prevalence, rates of
comorbidity, and rates of health risk
behaviors among elementary-age youth
with and without ADHD as determined
by a rigorous case definition developed
by the principal investigators and in
collaboration with CDC scientists.
The purpose of the longitudinal
follow-up program is to study the longterm outcomes and health status for
children with ADHD identified and
treated in community settings through a
systematic follow-up of the subjects
who participated in the PLAY Study
Collaborative. There is a considerable
interest in the long-term outcomes of
youth with ADHD as well as the effects
of treatment, lack of treatment, and
quality of care in average U.S.
communities, emphasizing the public
health importance of longitudinal
research in this area.
Given the lack of detailed information
about longitudinal development in
children with and without ADHD, there
is need to continue assessing the
children into older adolescence. This
program extends data collection for two
additional waves.
Minor changes to the assessment
instruments are planned in order to
include age appropriate assessment of
treatment and health risk behaviors in
older adolescents, such as
understanding motor vehicle operation
and dating behavior.
There are no costs to the respondents
other than their time. The total annual
burden hours are 765.
ESTIMATED ANNUALIZED BURDEN HOURS
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Type of
respondent
Parent
Parent
Parent
Parent
Parent
Parent
Parent
Parent
Parent
Parent
Parent
Parent
................
................
................
................
................
................
................
................
................
................
................
................
VerDate Nov<24>2008
Number of
respondents
Form name
ADHD Communication and Knowledge .......................................................
ADHD Treatment, Cost, and Client Satisfaction Questionnaire ..................
ADHD Treatment Questionnaire ..................................................................
Brief Impairment Scale ................................................................................
Critical School Events (Middle School) .......................................................
Critical School Events (High School) ...........................................................
Demographic Survey ...................................................................................
Health Risk Behavior Survey (Middle School) 11–13 years .......................
Health Risk Behavior Survey High School, 14+ years ................................
Parent-Child Relationship Inventory ............................................................
Parents’ Mental Health Questionnaire .........................................................
Quarterly update form ..................................................................................
11:51 Feb 05, 2010
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190
190
190
37
153
190
37
153
190
178
190
08FEN1
Responses
per
respondent
Avg. burden
per response
(in hours)
1
1
3
1
2
2
1
1
1
1
1
3
10/60
10/60
7/60
4/60
4/60
4/60
5/60
18/60
22/60
15/60
5/60
1/60
6206
Federal Register / Vol. 75, No. 25 / Monday, February 8, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of
respondent
Form name
Parent ................
Parent ................
Parent ................
Child ..................
Child ..................
Child ..................
Child ..................
Child ..................
Child ..................
Child ..................
Child ..................
Child ..................
Child ..................
Child ..................
Child ..................
Teacher .............
Social Isolation/Support ...............................................................................
Strengths and Difficulties Questionnaire (SDQ) ..........................................
Vanderbilt Parent Rating Scale ...................................................................
Brief Sensation Seeking Scale ....................................................................
Conflict in Adolescent Dating Relationships ................................................
Health Risk Behavior Survey (Middle School) 11–13 years .......................
Health Risk Behavior Survey (High School) 14+ years ..............................
MARSH—Self Description Questionnaire v I, 7–12 years ..........................
MARSH—Self Description Questionnaire v II, 13–15 years .......................
MARSH—Self Description Questionnaire v III 16+ years ...........................
Social Inventory (High School) 14+ years ...................................................
Olweus Bullying Questionnaire (High School) 14+ years ...........................
Pediatric Quality of Life Child (8–12) ...........................................................
Pediatric Quality of Life Teen (13+) .............................................................
Youth Demographic Survey, 16+ years .......................................................
Teacher Survey ............................................................................................
Dated: February 1, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–2600 Filed 2–5–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0489]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Recommendations
for Clinical Laboratory Improvement
Amendments of 1988 Waiver
Applications
AGENCY:
Food and Drug Administration,
HHS.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
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 10,
2010.
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:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0598. Also
VerDate Nov<24>2008
11:51 Feb 05, 2010
Jkt 220001
Number of
respondents
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–5156,
Daniel.Gittleson@fda.hhs.gov.
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.
Recommendations for Clinical
Laboratory Improvement Amendments
of 1988 Waiver Applications—21 CFR
Section 493 (OMB Control Number
0910–0598)—Extension
Congress passed the Clinical
Laboratory Improvements Amendment
(CLIA) (Public Law 100–578) in 1988 to
establish quality standards for all
laboratory testing. The purpose was to
ensure the accuracy, reliability, and
timeliness of patient test results
regardless of where the test took place.
CLIA requires that clinical laboratories
obtain a certificate from the Secretary of
Health and Human Services (the
Secretary), before accepting materials
derived from the human body for
laboratory tests (42 U.S.C. 263a(b)).
Laboratories that perform only tests that
are ‘‘simple’’ and that have an
‘‘insignificant risk of an erroneous
result’’ may obtain a certificate of waiver
(42 U.S.C. 263a(c)(2)). The Secretary has
delegated to FDA the authority to
determine whether particular tests
(waived tests) are ‘‘simple’’ and have ‘‘an
insignificant risk of an erroneous result’’
under CLIA (69 FR 22849, April 27,
2004). This guidance document
describes recommendations for device
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190
190
190
153
37
153
15
90
85
153
153
15
175
85
949
Responses
per
respondent
Avg. burden
per response
(in hours)
1
2
2
1
1
1
1
1
1
1
1
1
1
1
1
1
2/60
3/60
10/60
1/60
10/60
15/60
25/60
5/60
7/60
9/60
10/60
7/60
5/60
5/60
5/60
10/60
manufacturers submitting to FDA an
application for determination that a
cleared or approved device meets this
CLIA standard (CLIA waiver
application). The guidance recommends
that CLIA waiver applications include a
description of the features of the device
that make it ‘‘simple’’; a report
describing a hazard analysis that
identifies potential sources of error,
including a summary of the design and
results of flex studies and conclusions
drawn from the flex studies; a
description of fail-safe and failure alert
mechanisms and a description of the
studies validating these mechanisms; a
description of clinical tests that
demonstrate the accuracy of the test in
the hands of intended operators; and
statistical analyses of clinical study
results. Only new information
collections not already approved are
included in the estimate in the
following table. Quick reference
instructions are a short version of the
instructions that are written in simple
language and that can be posted.
The total number of reporting and
recordkeeping hours is 143,200 hours.
FDA bases the burden on an agency
analysis of premarket submissions with
clinical trials similar to the waived
laboratory tests. Based on previous
years’ experience with CLIA waiver
applications, FDA expects 40
manufacturers to submit one CLIA
waiver application per year. The time
required to prepare and submit a waiver
application, including the time needed
to assemble supporting data, averages
780 hours per waiver application for a
total of 31,200 hours for reporting.
Based on previous years experience
with CLIA waiver applications, FDA
expects that each manufacturer will
spend 2,800 hours creating and
E:\FR\FM\08FEN1.SGM
08FEN1
]]>Agencies
[Federal Register Volume 75, Number 25 (Monday, February 8, 2010)]
[Notices]
[Pages 6205-6206]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-2600]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-10-0747]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
Maryam I. Daneshvar, the CDC Reports Clearance Officer, at (404) 639-
5960 or send an e-mail to omb@cdc.gov. Send written comments to CDC
Desk Officer, Office of Management and Budget, Washington, DC or by fax
to (202) 395-5806. Written comments should be received within 30 days
of this notice.
Proposed Project
Longitudinal follow-up of Youth with Attention-Deficit/
Hyperactivity Disorder identified in Community Settings: Examining
Health Status, Correlates, and Effects associated with treatment for
ADHD (OMB 0920-0747, exp. 7/31/2010)--Revision--National
Center on Birth Defects and Developmental Disabilities (NCBDDD),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
This project will collect data from proxy respondents and youths
with and without Attention-Deficit/Hyperactivity Disorder (ADHD). This
program addresses the Healthy People 2010 focus area of Mental Health
and Mental Disorders, and describes the prevalence, incidence, long-
term outcomes, treatment(s), select co-morbid conditions, secondary
conditions, and health risk behavior of youth with ADHD relative to
youth without ADHD.
The National Center on Birth Defects and Developmental Disabilities
at CDC promotes the health of children with developmental disorders. As
part of these efforts, two contracts were awarded in FY 2007-2010 to
follow up a sample of children originally enrolled in community-based
epidemiological research on ADHD among elementary-aged youth, known as
the Project to Learn about ADHD in Youth (PLAY Study Collaborative),
which informed community-based prevalence, rates of comorbidity, and
rates of health risk behaviors among elementary-age youth with and
without ADHD as determined by a rigorous case definition developed by
the principal investigators and in collaboration with CDC scientists.
The purpose of the longitudinal follow-up program is to study the
long-term outcomes and health status for children with ADHD identified
and treated in community settings through a systematic follow-up of the
subjects who participated in the PLAY Study Collaborative. There is a
considerable interest in the long-term outcomes of youth with ADHD as
well as the effects of treatment, lack of treatment, and quality of
care in average U.S. communities, emphasizing the public health
importance of longitudinal research in this area.
Given the lack of detailed information about longitudinal
development in children with and without ADHD, there is need to
continue assessing the children into older adolescence. This program
extends data collection for two additional waves.
Minor changes to the assessment instruments are planned in order to
include age appropriate assessment of treatment and health risk
behaviors in older adolescents, such as understanding motor vehicle
operation and dating behavior.
There are no costs to the respondents other than their time. The
total annual burden hours are 765.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Avg. burden
Type of respondent Form name Number of Responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Parent......................... ADHD Communication and 190 1 10/60
Knowledge.
Parent......................... ADHD Treatment, Cost, and 190 1 10/60
Client Satisfaction
Questionnaire.
Parent......................... ADHD Treatment Questionnaire... 190 3 7/60
Parent......................... Brief Impairment Scale......... 190 1 4/60
Parent......................... Critical School Events (Middle 37 2 4/60
School).
Parent......................... Critical School Events (High 153 2 4/60
School).
Parent......................... Demographic Survey............. 190 1 5/60
Parent......................... Health Risk Behavior Survey 37 1 18/60
(Middle School) 11-13 years.
Parent......................... Health Risk Behavior Survey 153 1 22/60
High School, 14+ years.
Parent......................... Parent-Child Relationship 190 1 15/60
Inventory.
Parent......................... Parents' Mental Health 178 1 5/60
Questionnaire.
Parent......................... Quarterly update form.......... 190 3 1/60
[[Page 6206]]
Parent......................... Social Isolation/Support....... 178 1 2/60
Parent......................... Strengths and Difficulties 190 2 3/60
Questionnaire (SDQ).
Parent......................... Vanderbilt Parent Rating Scale. 190 2 10/60
Child.......................... Brief Sensation Seeking Scale.. 190 1 1/60
Child.......................... Conflict in Adolescent Dating 153 1 10/60
Relationships.
Child.......................... Health Risk Behavior Survey 37 1 15/60
(Middle School) 11-13 years.
Child.......................... Health Risk Behavior Survey 153 1 25/60
(High School) 14+ years.
Child.......................... MARSH--Self Description 15 1 5/60
Questionnaire v I, 7-12 years.
Child.......................... MARSH--Self Description 90 1 7/60
Questionnaire v II, 13-15
years.
Child.......................... MARSH--Self Description 85 1 9/60
Questionnaire v III 16+ years.
Child.......................... Social Inventory (High School) 153 1 10/60
14+ years.
Child.......................... Olweus Bullying Questionnaire 153 1 7/60
(High School) 14+ years.
Child.......................... Pediatric Quality of Life Child 15 1 5/60
(8-12).
Child.......................... Pediatric Quality of Life Teen 175 1 5/60
(13+).
Child.......................... Youth Demographic Survey, 16+ 85 1 5/60
years.
Teacher........................ Teacher Survey................. 949 1 10/60
----------------------------------------------------------------------------------------------------------------
Dated: February 1, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2010-2600 Filed 2-5-10; 8:45 am]
BILLING CODE 4163-18-P
