Agency Forms Undergoing Paperwork Reduction Act Review, 49381-49382 [E9-23309]
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49381
Federal Register / Vol. 74, No. 186 / Monday, September 28, 2009 / Notices
grants and cooperative agreements. In
addition to allowing for uniformity of
information collection, this format will
support systematic electronic collection
and submission of information. The
form contains non-personal identifying
data elements and a section for a
performance narrative.
There are no costs to respondents
other than their time. The total
estimated annual burden hours are
11,676. This estimate reflects an
increase from the 60 day notice as a
result of an increase in respondents and
adjustments to average burden hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
(estimated)
Respondents
States: Section 317 Immunization Program—Reaching More Children &
Adults ...........................................................................................................
States: Section 317 Immunization Program—Innovative Initiatives ................
States: Section 317 Immunization Program—Communication & Provider
Education .....................................................................................................
States: Section 317 Immunization Program—Strengthening the Evidence
Base .............................................................................................................
States: Healthcare Associated Infections—Emerging Infections Program .....
States: Healthcare Associated Infections—Epidemiology & Laboratory Capacity ............................................................................................................
States: Health Information Technology and Public Health ..............................
Universities: Health Information Technology Professionals in Health Care ....
States: Communities Putting Prevention to Work—Quitline Support ..............
States: Communities Putting Prevention to Work—Policy Activities ...............
States: Communities Putting Prevention to Work—Policy Implementation ....
States: Communities Putting Prevention to Work—Community Policy Activities ................................................................................................................
Communities: Communities Putting Prevention to Work—Policy Implementation .............................................................................................................
State Cancer Registries: Comparative Effectiveness Research to Enhance
Cancer Registry Data Systems ....................................................................
Universities: Comparative Effectiveness Research to Improve Prevention
and Wellness ................................................................................................
Dated: September 21, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–23311 Filed 9–25–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
srobinson on DSKHWCL6B1PROD with NOTICES
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.
16:33 Sep 25, 2009
Jkt 217001
6
6
1,536
360
10
4
6
240
64
10
4
4
6
6
1,536
240
52
64
30
50
50
50
4
4
4
4
4
2
6
6
6
2
2
1
1,248
1,536
720
400
400
100
40
4
16
2,560
40
2
8
640
15
4
2
120
5
4
2
40
Evaluating the Quality of Interview
Data Collected by Teratology
Information Services About Pregnancy
Outcomes, Maternal and Infant Health,
Following Medication Use During
Pregnancy and Lactation—New—
National Center on Birth Defects and
Developmental Disabilities (NCBDDD),
Centers for Disease Control and
Prevention (CDC).
This data collection is based on the
following components of the Public
Health Service Act: (1) Act 42 USC 241,
Section 301, which authorizes
‘‘research, investigations, experiments,
demonstrations, and studies relating to
the causes, diagnosis, treatment, control,
and prevention of physical and mental
diseases and impairments of man.’’ (2)
42 USC 247b–4, Section 317 C, which
authorizes the activities of the National
Center on Birth Defects and
Developmental Disabilities. This section
was created by Public Law 106–310,
also known as ‘‘the Children’s Health
Act of 2000.’’ This portion of the code
has also been amended by Public Law
108–154, which is also known as the
‘‘Birth Defects and Developmental
Disabilities Prevention Act of 2003’’.
Frm 00022
Fmt 4703
Sfmt 4703
Total burden
(in hours)
4
4
Proposed Project
PO 00000
Average
burden per
response
(in hours)
64
15
Background and Brief Description
[30 Day–09–07AA]
VerDate Nov<24>2008
Number of
responses per
respondent
The use of a number of medications
during pregnancy is known to be
associated with serious adverse effects
in children. However, because pregnant
and lactating women are traditionally
excluded from clinical trials, and
because premarketing animal studies do
not necessarily predict the experience of
humans, little information is available
about the safety of most prescription
medications during pregnancy and
lactation at the time they are marketed.
Nevertheless, many women
inadvertently use medications early in
gestation before realizing they are
pregnant, and many maternal conditions
require treatment during pregnancy and
breastfeeding to safeguard the health of
both mother and infant. Currently, the
United States does not does not conduct
comprehensive monitoring for
pregnancy or infant outcomes related to
medication exposures. To try to address
these concerns, a number of
pharmaceutical manufacturers have
established pregnancy drug registries to
monitor the effects of use of selected
medications during pregnancy on
pregnancy outcomes and fetal and
infant health. In some instances, the
U.S. Food and Drug Administration has
required postmarketing monitoring of
pregnancy outcomes after medication
E:\FR\FM\28SEN1.SGM
28SEN1
49382
Federal Register / Vol. 74, No. 186 / Monday, September 28, 2009 / Notices
exposure as a condition of new drug
approval. However, registries such as
these monitor only a small number of
medications, and many suffer from
methodologic limitations including high
loss to follow-up rates and incomplete
or nonspecific outcome information.
Teratology Information Services (TIS)
utilize trained specialists to provide free
phone consultation, risk assessment,
and counseling about exposures during
pregnancy and breastfeeding—including
medications—to women and healthcare
providers. Altogether, they respond to
approximately 70,000–100,000 inquiries
each year in the United States and
Canada. Because they have direct
contact with pregnant and breastfeeding
women, TIS are in a unique position to
monitor the effects of medication
exposures during pregnancy and
lactation. The objective of this project is
to assess the quality of information on
(1) pregnancy outcomes (e.g., live birth,
stillbirth, premature birth, low birth
weight, etc.) and (2) maternal and infant
health following medication use during
pregnancy and lactation that can be
obtained from maternal interviews
conducted by TIS in the U.S. The
project will assess the willingness of
pregnant and breastfeeding women who
contact a TIS about medication
exposure to participate in and complete
a follow-up study; whether these
women are similar in demographic
characteristics to the U.S. population of
child-bearing age women; the specificity
and completeness of the information
obtained from such a study about
pregnancy outcomes, and maternal and
infant health; and the amount of time
required to conduct the follow-up.
Within a continuous six-month
period, three individual TIS will recruit
all women who contact their service (up
to a maximum of 250 enrollees per TIS)
who have used any prescription or overthe-counter medication, vitamin, herbal,
or other dietary supplement during
pregnancy or while breastfeeding to
participate in a follow-up study.
Informed consent to participate will be
obtained from each woman by
telephone. For each pregnant woman
who agrees to participate, the TIS will
then conduct 4 telephone interviews: (1)
At enrollment; (2) during the third
trimester of pregnancy; (3)
approximately one month after delivery;
and (4) when the infant is about 3
months old. For each breastfeeding
woman who agrees to participate, the
TIS will then conduct 3 telephone
interviews: (1) At enrollment; (2)
approximately one month after
enrollment; and (3) 3 months after
enrollment, if the woman is still taking
medication and still breastfeeding. The
interviews will assess maternal and fetal
health throughout pregnancy, and
maternal and infant health at delivery,
during the newborn and early infancy
period, and while breastfeeding, and
correlate these outcomes with
medication exposure during pregnancy
and while breastfeeding. There is no
cost to respondents other than their
time. The total estimated annualized
burden is 516 hours.
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents
Responses
per
respondent
Avg. burden
per response
(in hours)
Type of respondent
Form name
All Respondents ..............................................
Screened Eligible Respondents- ....................
Pregnancy Exposure (Group 1)/Lactation Exposure (Group 2)/Pregnancy and Lactation
Exposure (Group 3).
Groups 1, 2 and 3 ...........................................
Group 1 and 3 .................................................
Telephone script .............................................
Tracking ..........................................................
Consent ..........................................................
294
250
250
1
1
1
3/60
5/60
20/60
Enrollment ......................................................
Initial Pregnancy .............................................
Follow-up Pregnancy .....................................
Initial Infant .....................................................
Follow-up Infant ..............................................
Initial breastfeeding ........................................
Follow-up breastfeeding .................................
250
200
200
200
200
100
100
1
1
1
1
1
1
1.5
10/60
30/60
20/60
20/60
15/60
20/60
15/60
Groups 2 and 3 ...............................................
Dated: September 18, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–23309 Filed 9–25–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
srobinson on DSKHWCL6B1PROD with NOTICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Proposed Projects:
Title: Project LAUNCH Cross-Site
Evaluation.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF), U.S.
VerDate Nov<24>2008
16:33 Sep 25, 2009
Jkt 217001
Department of Health and Human
Services, is planning to collect data as
part of a cross-site evaluation of a new
initiative called Project LAUNCH
(Linking Actions for Unmet Needs in
Children’s Health): Project LAUNCH is
intended to promote the healthy
development and wellness of children
ages birth to eight years. A total of 18
Project LAUNCH grantees will be
funded to improve coordination among
child-serving systems, build
infrastructure, and improve methods for
providing services. Grantees will also
implement a range of public health
strategies to support young child
wellness in a designated locality.
Data for the cross-site evaluation of
Project LAUNCH will be collected
through: (1) Interviews conducted
during annual site visits to Project
LAUNCH grantees, and (2) semi-annual
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
reports that will be submitted
electronically on a Web-based dataentry system. Information will be
collected from all Project LAUNCH
grantees.
During annual site visits, researchers
will conduct interviews with Project
LAUNCH service providers and
collaborators in States/Tribes and local
communities of focus. Site visitors will
ask program administrators questions
about all Project LAUNCH activities,
including: infrastructure development;
collaboration and coordination among
partner agencies, organizations, and
service providers; and development,
implementation, and refinement of
service strategies.
As part of the proposed data
collection, Project LAUNCH staff will be
asked to submit semi-annual electronic
reports on State/Tribal and local
E:\FR\FM\28SEN1.SGM
28SEN1
]]>Agencies
[Federal Register Volume 74, Number 186 (Monday, September 28, 2009)]
[Notices]
[Pages 49381-49382]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23309]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30 Day-09-07AA]
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
Evaluating the Quality of Interview Data Collected by Teratology
Information Services About Pregnancy Outcomes, Maternal and Infant
Health, Following Medication Use During Pregnancy and Lactation--New--
National Center on Birth Defects and Developmental Disabilities
(NCBDDD), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
This data collection is based on the following components of the
Public Health Service Act: (1) Act 42 USC 241, Section 301, which
authorizes ``research, investigations, experiments, demonstrations, and
studies relating to the causes, diagnosis, treatment, control, and
prevention of physical and mental diseases and impairments of man.''
(2) 42 USC 247b-4, Section 317 C, which authorizes the activities of
the National Center on Birth Defects and Developmental Disabilities.
This section was created by Public Law 106-310, also known as ``the
Children's Health Act of 2000.'' This portion of the code has also been
amended by Public Law 108-154, which is also known as the ``Birth
Defects and Developmental Disabilities Prevention Act of 2003''.
The use of a number of medications during pregnancy is known to be
associated with serious adverse effects in children. However, because
pregnant and lactating women are traditionally excluded from clinical
trials, and because premarketing animal studies do not necessarily
predict the experience of humans, little information is available about
the safety of most prescription medications during pregnancy and
lactation at the time they are marketed. Nevertheless, many women
inadvertently use medications early in gestation before realizing they
are pregnant, and many maternal conditions require treatment during
pregnancy and breastfeeding to safeguard the health of both mother and
infant. Currently, the United States does not does not conduct
comprehensive monitoring for pregnancy or infant outcomes related to
medication exposures. To try to address these concerns, a number of
pharmaceutical manufacturers have established pregnancy drug registries
to monitor the effects of use of selected medications during pregnancy
on pregnancy outcomes and fetal and infant health. In some instances,
the U.S. Food and Drug Administration has required postmarketing
monitoring of pregnancy outcomes after medication
[[Page 49382]]
exposure as a condition of new drug approval. However, registries such
as these monitor only a small number of medications, and many suffer
from methodologic limitations including high loss to follow-up rates
and incomplete or nonspecific outcome information.
Teratology Information Services (TIS) utilize trained specialists
to provide free phone consultation, risk assessment, and counseling
about exposures during pregnancy and breastfeeding--including
medications--to women and healthcare providers. Altogether, they
respond to approximately 70,000-100,000 inquiries each year in the
United States and Canada. Because they have direct contact with
pregnant and breastfeeding women, TIS are in a unique position to
monitor the effects of medication exposures during pregnancy and
lactation. The objective of this project is to assess the quality of
information on (1) pregnancy outcomes (e.g., live birth, stillbirth,
premature birth, low birth weight, etc.) and (2) maternal and infant
health following medication use during pregnancy and lactation that can
be obtained from maternal interviews conducted by TIS in the U.S. The
project will assess the willingness of pregnant and breastfeeding women
who contact a TIS about medication exposure to participate in and
complete a follow-up study; whether these women are similar in
demographic characteristics to the U.S. population of child-bearing age
women; the specificity and completeness of the information obtained
from such a study about pregnancy outcomes, and maternal and infant
health; and the amount of time required to conduct the follow-up.
Within a continuous six-month period, three individual TIS will
recruit all women who contact their service (up to a maximum of 250
enrollees per TIS) who have used any prescription or over-the-counter
medication, vitamin, herbal, or other dietary supplement during
pregnancy or while breastfeeding to participate in a follow-up study.
Informed consent to participate will be obtained from each woman by
telephone. For each pregnant woman who agrees to participate, the TIS
will then conduct 4 telephone interviews: (1) At enrollment; (2) during
the third trimester of pregnancy; (3) approximately one month after
delivery; and (4) when the infant is about 3 months old. For each
breastfeeding woman who agrees to participate, the TIS will then
conduct 3 telephone interviews: (1) At enrollment; (2) approximately
one month after enrollment; and (3) 3 months after enrollment, if the
woman is still taking medication and still breastfeeding. The
interviews will assess maternal and fetal health throughout pregnancy,
and maternal and infant health at delivery, during the newborn and
early infancy period, and while breastfeeding, and correlate these
outcomes with medication exposure during pregnancy and while
breastfeeding. There is no cost to respondents other than their time.
The total estimated annualized burden is 516 hours.
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Avg. burden
Type of respondent Form name Number of Responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
All Respondents....................... Telephone script........ 294 1 3/60
Screened Eligible Respondents-........ Tracking................ 250 1 5/60
Pregnancy Exposure (Group 1)/Lactation Consent................. 250 1 20/60
Exposure (Group 2)/Pregnancy and
Lactation Exposure (Group 3).
Groups 1, 2 and 3..................... Enrollment.............. 250 1 10/60
Group 1 and 3......................... Initial Pregnancy....... 200 1 30/60
Follow-up Pregnancy..... 200 1 20/60
Initial Infant.......... 200 1 20/60
Follow-up Infant........ 200 1 15/60
Groups 2 and 3........................ Initial breastfeeding... 100 1 20/60
Follow-up breastfeeding. 100 1.5 15/60
----------------------------------------------------------------------------------------------------------------
Dated: September 18, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E9-23309 Filed 9-25-09; 8:45 am]
BILLING CODE 4163-18-P
