Agency Forms Undergoing Paperwork Reduction Act Review, 67517-67518 [E8-27084]
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Federal Register / Vol. 73, No. 221 / Friday, November 14, 2008 / Notices
2. Thrift Savings Plan activity report
by the Executive Director.
a. Monthly Participant Activity
Report.
b. Legislative Report.
c. Investment Performance Review.
3. Securities Lending Activity.
4. 2008 Participant Survey.
5. Internal Controls Update.
6. Vendor Financials Follow-up.
7. 2009 FRTIB Meeting Calendar.
Parts Closed to the Public
8. Security.
CONTACT PERSON FOR MORE INFORMATION:
Thomas J. Trabucco, Director, Office of
External Affairs, (202) 942–1640.
Dated: November 7, 2008.
Thomas K. Emswiler,
Secretary, Federal Retirement Thrift
Investment Board.
[FR Doc. E8–27020 Filed 11–12–08; 11:15
am]
BILLING CODE 6760–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–08–07AA]
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) 395–6974. Written
comments should be received within 30
days of this notice.
jlentini on PROD1PC65 with NOTICES
Proposed Project
Pilot Project for a National Monitoring
System for Major Adverse Effects of
Medication Use During Pregnancy and
Lactation—New—National Center on
Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
VerDate Aug<31>2005
16:29 Nov 13, 2008
Jkt 217001
Background and Brief Description
This data collection is based on the
following components of the Public
Health Service Act: (1) Act 42 U.S.C.
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 U.S.C. 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 have a
comprehensive early warning system for
major adverse pregnancy or infant
outcomes related to medication
exposures.
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 adverse effects of
medication exposures during pregnancy
and lactation. The objective of this
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67517
project is to conduct a pilot study to
assess whether TIS in the United States
can serve as an effective monitoring and
early warning system for major adverse
effects on (1) pregnancy outcomes (e.g.,
live birth, stillbirth, premature birth,
low birth weight, etc.) and (2) maternal
and infant health. 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
adverse 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.
E:\FR\FM\14NON1.SGM
14NON1
67518
Federal Register / Vol. 73, No. 221 / Friday, November 14, 2008 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS
Form name
All Respondents ........................................
Telephone script for permission to seek
consent (C1a or C1b).
Tracking Form (C1c) ................................
Consent (C2a or C2b) .............................
..................................................................
..................................................................
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 ...........................................
Groups 2 and 3 .........................................
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors,
National Institute for Occupational
Safety and Health (BSC, NIOSH)
jlentini on PROD1PC65 with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting for the
aforementioned committee:
Time and Date: 8:30 a.m.–3:30 p.m.,
December 4, 2008.
Place: Marriott Crystal City at Reagan
National, 1999 Jefferson Davis Highway,
Arlington, VA 22202.
Status: Open to the public, limited only by
the space available. The meeting room
accommodates approximately 50 people.
Teleconference available toll-free; please dial
(866) 700–6634, Participant Pass Code
3756066.
Purpose: The Secretary, the Assistant
Secretary for Health, and by delegation the
Director, Centers for Disease Control and
Prevention, are authorized under Sections
301 and 308 of the Public Health Service Act
to conduct directly or by grants or contracts,
research, experiments, and demonstrations
relating to occupational safety and health and
to mine health. The Board of Scientific
Counselors shall provide guidance to the
Director, National Institute for Occupational
Safety and Health on research and prevention
programs. Specifically, the Board shall
provide guidance on the Institute’s research
activities related to developing and
16:29 Nov 13, 2008
Jkt 217001
Avg. burden per
response
(in hours)
294
1
3/60
250
250
............................
............................
1
1
............................
............................
5/60
20/60
............................
............................
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
Enrollment (D1) ........................................
Initial pregnancy Questionnaire (D2) .......
Follow-up pregnancy questionnaire (D3)
Initial infant questionnaire (D4) ................
Follow-up infant questionnaire (D5) ........
Initial breastfeeding questionnaire (D6) ...
Follow-up breastfeeding questionnaire
(D7).
Dated: November 6, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–27084 Filed 11–13–08; 8:45 am]
VerDate Aug<31>2005
No. of responses
per respondent
No. of respondents
Type of respondent
evaluating hypotheses, systematically
documenting findings and disseminating
results. The Board shall evaluate the degree
to which the activities of the National
Institute for Occupational Safety and Health:
(1) Conform to appropriate scientific
standards, (2) address current, relevant
needs, and (3) produce intended results.
Matters To Be Discussed: Agenda items
include a Report by the Acting Director of
NIOSH; National Academies (NA)
Recommendations for NIOSH Programs;
Implementation of NA Recommendations in
Agriculture, Forestry and Fishing;
Occupational Safety and Health Surveillance
Needs; NIOSH Nanotechnology Research
Strategic Plan; National Occupational
Research Agenda; Future Meetings and
Closing Remarks.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Roger Rosa, Executive Secretary, BSC,
NIOSH, CDC, 395 E Street, SW., Suite 9200,
Patriots Plaza Building, Washington, DC
20201, telephone (202) 245–0655, fax (202)
245–0664.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both the CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: November 6, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–27052 Filed 11–13–08; 8:45 am]
BILLING CODE 4163–19–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS-R–74, CMS–R–
107, CMS–2786U, CMS–R–285 and CMS–R–
245]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Income and
Eligibility Verification System; Use:
This collection is necessary to verify
income and eligibility requirements for
Medicaid beneficiaries, as required by
Section 1137 of the Social Security Act.
Form Number: CMS–R–74 (OMB#
AGENCY:
E:\FR\FM\14NON1.SGM
14NON1
]]>Agencies
[Federal Register Volume 73, Number 221 (Friday, November 14, 2008)]
[Notices]
[Pages 67517-67518]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27084]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-08-07AA]
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) 395-6974. Written comments should be received within 30 days
of this notice.
Proposed Project
Pilot Project for a National Monitoring System for Major Adverse
Effects of 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 U.S.C. 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 U.S.C. 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 have a comprehensive
early warning system for major adverse pregnancy or infant outcomes
related to medication exposures.
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 adverse effects of medication exposures during pregnancy
and lactation. The objective of this project is to conduct a pilot
study to assess whether TIS in the United States can serve as an
effective monitoring and early warning system for major adverse effects
on (1) pregnancy outcomes (e.g., live birth, stillbirth, premature
birth, low birth weight, etc.) and (2) maternal and infant health. 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 adverse 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.
[[Page 67518]]
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Avg. burden per
Type of respondent Form name No. of No. of responses response (in
respondents per respondent hours)
----------------------------------------------------------------------------------------------------------------
All Respondents................. Telephone script for 294 1 3/60
permission to seek
consent (C1a or C1b).
Screened Eligible Respondents--. Tracking Form (C1c)..... 250 1 5/60
Pregnancy Exposure (group 1).... Consent (C2a or C2b).... 250 1 20/60
Lactation Exposure (group 2).... ........................ ................ ................ ................
Pregnancy and Lactation Exposure ........................ ................ ................ ................
(group 3).
Groups 1, 2 and 3............... Enrollment (D1)......... 250 1 10/60
Group 1 and 3................... Initial pregnancy 200 1 30/60
Questionnaire (D2).
Follow-up pregnancy 200 1 20/60
questionnaire (D3).
Initial infant 200 1 20/60
questionnaire (D4).
Follow-up infant 200 1 15/60
questionnaire (D5).
Groups 2 and 3.................. Initial breastfeeding 100 1 20/60
questionnaire (D6).
Follow-up breastfeeding 100 1.5 15/60
questionnaire (D7).
----------------------------------------------------------------------------------------------------------------
Dated: November 6, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E8-27084 Filed 11-13-08; 8:45 am]
BILLING CODE 4163-18-P
