Federal Register/Vol. 74, No. 186/Monday, September 28, 2009

49382 Federal Register / Vol. 74, No. 186 / Monday, September 28, 2009 / Notices

exposure as a condition of new drug pregnancy and lactation that can be telephone. For each pregnant woman approval. However, registries such as obtained from maternal interviews who agrees to participate, the TIS will these monitor only a small number of conducted by TIS in the U.S. The then conduct 4 telephone interviews: (1) medications, and many suffer from project will assess the willingness of At enrollment; (2) during the third methodologic limitations including high pregnant and breastfeeding women who trimester of pregnancy; (3) loss to follow-up rates and incomplete contact a TIS about medication approximately one month after delivery; or nonspecific outcome information. exposure to participate in and complete and (4) when the infant is about 3 Teratology Information Services (TIS) a follow-up study; whether these months old. For each breastfeeding utilize trained specialists to provide free women are similar in demographic woman who agrees to participate, the phone consultation, risk assessment, characteristics to the U.S. population of TIS will then conduct 3 telephone and counseling about exposures during child-bearing age women; the specificity interviews: (1) At enrollment; (2) pregnancy and breastfeeding—including and completeness of the information approximately one month after medications—to women and healthcare obtained from such a study about enrollment; and (3) 3 months after providers. Altogether, they respond to pregnancy outcomes, and maternal and enrollment, if the woman is still taking approximately 70,000–100,000 inquiries infant health; and the amount of time each year in the United States and required to conduct the follow-up. medication and still breastfeeding. The Canada. Because they have direct Within a continuous six-month interviews will assess maternal and fetal contact with pregnant and breastfeeding period, three individual TIS will recruit health throughout pregnancy, and women, TIS are in a unique position to all women who contact their service (up maternal and infant health at delivery, monitor the effects of medication to a maximum of 250 enrollees per TIS) during the newborn and early infancy exposures during pregnancy and who have used any prescription or over- period, and while breastfeeding, and lactation. The objective of this project is the-counter medication, vitamin, herbal, correlate these outcomes with to assess the quality of information on or other dietary supplement during medication exposure during pregnancy (1) pregnancy outcomes (e.g., live birth, pregnancy or while breastfeeding to and while breastfeeding. There is no stillbirth, premature birth, low birth participate in a follow-up study. cost to respondents other than their weight, etc.) and (2) maternal and infant Informed consent to participate will be time. The total estimated annualized health following medication use during obtained from each woman by burden is 516 hours.

ESTIMATE OF ANNUALIZED BURDEN HOURS

Responses Avg. burden Type of respondent Form name Number of 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 Ex- Consent ...... 250 1 20/60 posure (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. Department of Health and Human reports that will be submitted Maryam I. Daneshvar, Services, is planning to collect data as electronically on a Web-based data- Acting Reports Clearance Officer, Centers for part of a cross-site evaluation of a new entry system. Information will be Disease Control and Prevention. initiative called Project LAUNCH collected from all Project LAUNCH [FR Doc. E9–23309 Filed 9–25–09; 8:45 am] (Linking Actions for Unmet Needs in grantees. BILLING CODE 4163–18–P Children’s Health): Project LAUNCH is During annual site visits, researchers intended to promote the healthy will conduct interviews with Project development and wellness of children LAUNCH service providers and DEPARTMENT OF HEALTH AND ages birth to eight years. A total of 18 collaborators in States/Tribes and local HUMAN SERVICES Project LAUNCH grantees will be communities of focus. Site visitors will funded to improve coordination among ask program administrators questions Administration for Children and child-serving systems, build about all Project LAUNCH activities, Families infrastructure, and improve methods for including: infrastructure development; providing services. Grantees will also Submission for OMB Review; collaboration and coordination among implement a range of public health Comment Request partner agencies, organizations, and strategies to support young child service providers; and development, Proposed Projects: wellness in a designated locality. implementation, and refinement of Title: Project LAUNCH Cross-Site Data for the cross-site evaluation of service strategies. Evaluation. Project LAUNCH will be collected As part of the proposed data OMB No.: New Collection. through: (1) Interviews conducted collection, Project LAUNCH staff will be Description: The Administration for during annual site visits to Project asked to submit semi-annual electronic Children and Families (ACF), U.S. LAUNCH grantees, and (2) semi-annual reports on State/Tribal and local

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systems development and on services provider settings. Information provided Project Director, Local Child Wellness that children and families receive. The in these reports will be aggregated on a Coordinator, Local Wellness Council electronic data reports also will collect quarterly basis, and reported semi- Members, Local Evaluator, and Local data about other Project LAUNCH- annually. Service Providers. funded service enhancements, such as Respondents: State/Tribal Child trainings, Project LAUNCH systems Wellness Coordinator, State/Tribal change activities, and changes in Wellness Council Members, State ECCS

ANNUAL BURDEN ESTIMATES’>

Annual Number of Average Estimated Instrument number of responses per burden hours annual burden respondents respondent per response hours

Site Visit Interview Guide ...... 216 1 1.25 270 Electronic Data Reporting: Systems Measures ...... 18 2 4 144 Electronic Data Reporting: Services Measures ...... 18 2 8 288

Estimated Annual Burden Hours: 702 amended (5 U.S.C. App.), notice is DEPARTMENT OF HEALTH AND hours. hereby given of the following meeting. HUMAN SERVICES Additional Information The meeting will be closed to the public in accordance with the National Institutes of Health Copies of the proposed collection may provisions set forth in sections be obtained by writing to the National Cancer Institute; Notice of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Closed Meetings Administration for Children and as amended. The grant applications and Families, Office of Planning, Research the discussions could disclose Pursuant to section 10(d) of the and Evaluation, 370 L’Enfant confidential trade secrets or commercial Federal Advisory Committee Act, as Promenade, SW., Washington, DC property such as patentable material, amended (5 U.S.C. App.), notice is 20447, Attn: OPRE Reports Clearance and personal information concerning hereby given of the following meetings. Officer. All requests should be individuals associated with the grant The meetings will be closed to the identified by the title of the information applications, the disclosure of which public in accordance with the collection. E-mail address: would constitute a clearly unwarranted provisions set forth in sections [email protected]. invasion of personal privacy. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., OMB Comment as amended. The grant applications Name of Committee: National and/or contract proposals and the OMB is required to make a decision Institute of Mental Health Special discussions could disclose confidential concerning the collection of information Emphasis Panel. K99. trade secrets or commercial property between 30 and 60 days after Date: October 29, 2009. such as patentable material, and publication of this document in the Time: 1 p.m. to 5 p.m. personal information concerning Federal Register. Therefore, a comment Agenda: To review and evaluate grant individuals associated with the grant is best assured of having its full effect applications. applications and/or contract proposals, if OMB receives it within 30 days of the disclosure of which would publication. Written comments and Place: National Institutes of Health, constitute a clearly unwarranted recommendations for the proposed Neuroscience Center, 6001 Executive invasion of personal privacy. information collection should be sent Boulevard, Rockville, MD 20852. (Telephone Conference Call). Name of Committee: National Cancer directly to the following: Office of Institute Special Emphasis Panel. Management and Budget, Paperwork Contact Person: Megan Libbey, PhD, Pharmacodynamic Assays for Cancer Reduction Project, Fax: 202–395–6974. Scientific Review Officer, Division of Therapeutics. Attn: Desk Officer for the Extramural Activities, National Institute Date: October 6, 2009. Administration for Children and of Mental Health, NIH, Neuroscience Time: 11 a.m. to 1:30 p.m. Families. Center, 6001 Executive Blvd., Room Agenda: To review and evaluate contract 6148, MSC 9609, Rockville, MD 20852– proposals. Dated: September 17, 2009. 9609. 301–402–6807. Place: National Institutes of Health, 6116 Seth F. Chamberlain, [email protected]. Executive Boulevard, Room # 210, Rockville, OPRE Reports Clearance Officer. MD 20852. (Telephone Conference Call). (Catalogue of Federal Domestic Assistance [FR Doc. E9–23242 Filed 9–25–09; 8:45 am] Contact Person: Thomas M Vollberg, PhD, Program Nos. 93.242, Mental Health Research Scientific Review Officer, Special Review BILLING CODE M Grants; 93.281, Scientist Development and Logistics Branch, Division of Extramural Award, Scientist Development Award for Activities, National Cancer Institute, 6116 Clinicians, and Research Scientist Award; Executive Boulevard, Room 7142, Bethesda, DEPARTMENT OF HEALTH AND 93.282, Mental Health National Research MD 20892. 301–594–9582. HUMAN SERVICES Service Awards for Research Training, [email protected]. National Institutes of Health, HHS) This notice is being published less than 15 National Institutes of Health Dated: September 21, 2009. days prior to the meeting due to scheduling conflicts. Jennifer Spaeth, National Institute of Mental Health; Name of Committee: National Cancer Director, Office of Federal Advisory Institute Special Emphasis Panel. R13 Committee Policy. Notice of Closed Meeting Conference Grants Review. Pursuant to section 10(d) of the [FR Doc. E9–23337 Filed 9–25–09; 8:45 am] Date: October 29, 2009. Federal Advisory Committee Act, as BILLING CODE 4140–01–P Time: 1 p.m. to 5 p.m.

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