Federal Register / Vol. 74, No. 186 / Monday, September 28, 2009 / Notices 49381 

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

Respondents 

Number of 

respondents 

(estimated) 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

States: Section 317 Immunization Program—Reaching More Children & 

Adults ........................................................................................................... 64 4 6 1,536 

States: Section 317 Immunization Program—Innovative Initiatives ................ 15 4 6 360 

States: Section 317 Immunization Program—Communication & Provider 

Education ..................................................................................................... 10 4 6 240 

States: Section 317 Immunization Program—Strengthening the Evidence 

Base ............................................................................................................. 64 4 6 1,536 

States: Healthcare Associated Infections—Emerging Infections Program ..... 10 4 6 240 

States: Healthcare Associated Infections—Epidemiology & Laboratory Capacity ............................................................................................................ 52 4 6 1,248 

States: Health Information Technology and Public Health .............................. 64 4 6 1,536 

Universities: Health Information Technology Professionals in Health Care .... 30 4 6 720 

States: Communities Putting Prevention to Work—Quitline Support .............. 50 4 2 400 

States: Communities Putting Prevention to Work—Policy Activities ............... 50 4 2 400 

States: Communities Putting Prevention to Work—Policy Implementation .... 50 2 1 100 

States: Communities Putting Prevention to Work—Community Policy Activities ................................................................................................................ 40 4 16 2,560 

Communities: Communities Putting Prevention to Work—Policy Implementation ............................................................................................................. 40 2 8 640 

State Cancer Registries: Comparative Effectiveness Research to Enhance 

Cancer Registry Data Systems .................................................................... 15 4 2 120 

Universities: Comparative Effectiveness Research to Improve Prevention 

and Wellness ................................................................................................ 5 4 2 40 

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 

[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 


srobinson on DSKHWCL6B1PROD with NOTICES
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