Agency Forms Undergoing Paperwork Reduction Act Review, 67517-67518 [E8-27084]

Download as PDF 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 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