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

Type of respondent Form name Number of 

respondents 

Responses 

per 

respondent 

Avg. burden 

per response 

(in hours) 

All Respondents .............................................. Telephone script ............................................. 294 1 3/60 

Screened Eligible Respondents- .................... Tracking .......................................................... 250 1 5/60 

Pregnancy Exposure (Group 1)/Lactation Exposure (Group 2)/Pregnancy and Lactation 

Exposure (Group 3).

Consent .......................................................... 250 1 20/60 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

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. 

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 

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 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 74, No. 186 / Monday, September 28, 2009 / Notices 49383 

systems development and on services 

that children and families receive. The 

electronic data reports also will collect 

data about other Project LAUNCHfunded service enhancements, such as 

trainings, Project LAUNCH systems 

change activities, and changes in 

provider settings. Information provided 

in these reports will be aggregated on a 

quarterly basis, and reported semiannually. 

Respondents: State/Tribal Child 

Wellness Coordinator, State/Tribal 

Wellness Council Members, State ECCS 

Project Director, Local Child Wellness 

Coordinator, Local Wellness Council 

Members, Local Evaluator, and Local 

Service Providers. 

ANNUAL BURDEN ESTIMATES’> 

Instrument 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated 

annual burden 

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 

hours. 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447, Attn: OPRE Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

OPREinfocol1ection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–6974. 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: September 17, 2009. 

Seth F. Chamberlain, 

OPRE Reports Clearance Officer. 

[FR Doc. E9–23242 Filed 9–25–09; 8:45 am] 

BILLING CODE M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National 

Institute of Mental Health Special 

Emphasis Panel. K99. 

Date: October 29, 2009. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

(Telephone Conference Call). 

Contact Person: Megan Libbey, PhD, 

Scientific Review Officer, Division of 

Extramural Activities, National Institute 

of Mental Health, NIH, Neuroscience 

Center, 6001 Executive Blvd., Room 

6148, MSC 9609, Rockville, MD 20852– 

9609. 301–402–6807. 

libbeym@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.242, Mental Health Research 

Grants; 93.281, Scientist Development 

Award, Scientist Development Award for 

Clinicians, and Research Scientist Award; 

93.282, Mental Health National Research 

Service Awards for Research Training, 

National Institutes of Health, HHS) 

Dated: September 21, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–23337 Filed 9–25–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications 

and/or contract proposals and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel. 

Pharmacodynamic Assays for Cancer 

Therapeutics. 

Date: October 6, 2009. 

Time: 11 a.m. to 1:30 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6116 

Executive Boulevard, Room # 210, Rockville, 

MD 20852. (Telephone Conference Call). 

Contact Person: Thomas M Vollberg, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, 6116 

Executive Boulevard, Room 7142, Bethesda, 

MD 20892. 301–594–9582. 

vollbert@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to scheduling 

conflicts. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel. R13 

Conference Grants Review. 

Date: October 29, 2009. 

Time: 1 p.m. to 5 p.m. 


srobinson on DSKHWCL6B1PROD with NOTICES