Proposed Data Collections Submitted for Public Comment and Recommendations, 38937-38938 [05-13245]

Download as PDF 38937 Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Notices is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Morbidity Monitoring Project (MMP)—New—National Center for HIV, STD and TB Prevention (NCHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description: This proposed data collection supplements the HIV/AIDS surveillance programs in 26 selected state and local health departments, which collect information on persons diagnosed with, living with, and dying from HIV infection and AIDS and will incorporate data elements from two data collections: regimens. Collection of data from patient medical records will provide information on: demographics and insurance status; the prevalence and incidence of AIDS-defining opportunistic illnesses and comorbidities related to HIV disease; the receipt of prophylactic and antiretroviral medications; and whether patients are receiving screening and treatment according to Public Health Service guidelines. No other Federal agency collects national populationbased behavioral and clinical information from HIV-infected adults in care. The data will have significant implications for policy, program development, and resource allocation at the state/local and national levels. CDC is requesting approval for a 3year clearance for data collection. Data will be collected by 26 Reporting Areas (19 states, Puerto Rico and 6 separately funded cities). CDC estimates an average of 400 respondents per site, resulting in 10,400 respondents for the interview portion. There will be 2 medical record abstractors per site, resulting in 52 respondents for the medical record abstraction. Participation of respondents is voluntary and there is no cost to the respondents other than their time. Supplement to HIV/AIDS Surveillance (SHAS) project (0920–0262) and the Adult/Adolescent Spectrum of HIV Disease (ASD). Both projects stopped data collection in 2004. Although CDC receives surveillance data from all U.S. states, these supplemental surveillance data are needed to make estimates of key indicators, such as quality of HIVrelated ambulatory care and the severity of need for HIV-related care and services. A large number of cities and states are heavily impacted by the HIV/ AIDS epidemic, resulting in the need for population-based national estimates of HIV-related behaviors, clinical outcomes, and quality of HIV care. This project will collect data on behaviors and clinical outcomes from a probability sample of HIV-infected adults receiving care in the U.S. Collection of data from interviews with HIV-infected patients will provide information on patient demographics, and the current levels of behaviors that may facilitate HIV transmission: sexual and drug use behaviors; patients’ access to, use of and barriers to HIV-related secondary prevention services; utilization of HIV-related medical services; and adherence to drug ESTIMATE OF ANNUALIZED BURDEN TABLE Number of sites Type of data collection Average number of respondents/site Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Persons interviewed ................................. Medical record abstractors ...................... 26 26 400 2 10,400 52 1 200 45/60 1 7,800 10,400 Total .................................................. ........................ ........................ ........................ ........................ ........................ 18,200 Dated: June 21, 2005. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 05–13244 Filed 7–5–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–05–0425X] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the VerDate jul<14>2003 16:35 Jul 05, 2005 Jkt 205001 Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–371–5983 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project The National Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) Study— New—National Center for Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Children’s Health Act of 2000 mandated CDC to establish autism surveillance and research programs to address the number, incidence, correlates, and causes of autism and related disabilities. Under the E:\FR\FM\06JYN1.SGM 06JYN1 38938 Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Notices provisions of this act, CDC funded 5 CADDRE centers including the California Department of Health and Human Services, Colorado Department of Public Health and Environment, Johns Hopkins University, the University of Pennsylvania, and the University of North Carolina at Chapel Hill. CDC National Center for Birth Defect and Developmental Disabilities will participate as the 6th site. The multi-site, collaborative study will be an epidemiological investigation of possible causes for the autism spectrum disorders. developmental and physical exam of the child participant; (7) biological sampling of the child participant (blood and hair); and, (8) biological sampling of the biological parents of the child participant (blood only). OMB clearance is requested for the self administered questionnaires and buccal swab kit, the primary caregiver interview, and the child development interview. There is no cost to respondents other than their time. Data collection methods will consist of the following: (1) Medical and educational record review of the child participant; (2) medical record review of the biological mother of the child participant; (3) a packet sent to the participants with self-administered questionnaires and a buccal swab kit; (4) a telephone interview focusing on pregnancy-related events and early life history (biological mother and/or primary caregiver interview); (5) a child development interview (for case participants only) administered over the telephone or in-person; (6) a ESTIMATE OF ANNUALIZED BURDEN HOURS Number of respondents Survey Number of responses per respondent Average burden per response (in hrs.) Total burden (in hrs.) Cases: —Self administered questionnaires and buccal swab kit ......................... —Primary caregiver interview ................................................................... —Child development interview ................................................................. Controls: —Self administered questionnaires and buccal swab kit ......................... —Primary caregiver interview ................................................................... —Child development interview ................................................................. 644 644 644 1 1 1 3.0 40/60 3.0 1932 429 1932 1288 1288 1288 1 1 1 3.0 40/60 1.0 3864 859 1288 Total ................................................................................................... ........................ ........................ ........................ 10,304 Dated: June 21, 2005. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 05–13245 Filed 7–5–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day–05–0010] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–371–5983 and send comments to Seleda Perryman, VerDate jul<14>2003 16:35 Jul 05, 2005 Jkt 205001 CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project The National Birth Defects Prevention Study (OMB 0920–0010)—Extension— The Division of Birth Defects and Developmental Disabilities (DBDDD), National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 Background and Brief Description CDC has been monitoring the occurrence of serious birth defects and genetic diseases in Atlanta since 1967 through the Metropolitan Atlanta Congenital Defects Program (MACDP). The MACDP is a population-based surveillance system for birth defects in the 5 counties of Metropolitan Atlanta. Its primary purpose is to describe the spatial and temporal patterns of birth defects occurrence and serve as an early warning system for new teratogens. From 1993 to 1996, the Division of Birth Defects and Developmental Disabilities (DBDDD) conducted the Birth Defects Risk Factor Surveillance (BDRFS) study, a case-control study of risk factors for selected birth defects. Infants with birth defects were identified through MACDP and maternal interviews and clinical/ laboratory tests were conducted on approximately 300 cases and 100 controls per year. Controls were selected from among normal births in the same population. In 1997 the BDRFS became the National Birth Defects Prevention Study (NBDPS). The major components of the study did not change. The NBDPS is a case-control study of major birth defects that includes cases identified from existing birth defect E:\FR\FM\06JYN1.SGM 06JYN1

Agencies

[Federal Register Volume 70, Number 128 (Wednesday, July 6, 2005)]
[Notices]
[Pages 38937-38938]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13245]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-05-0425X]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-371-5983 
and send comments to Seleda Perryman, CDC Assistant Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
to omb@cdc.gov.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    The National Centers for Autism and Developmental Disabilities 
Research and Epidemiology (CADDRE) Study--New--National Center for 
Birth Defects and Developmental Disabilities (NCBDDD), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    The Children's Health Act of 2000 mandated CDC to establish autism 
surveillance and research programs to address the number, incidence, 
correlates, and causes of autism and related disabilities. Under the

[[Page 38938]]

provisions of this act, CDC funded 5 CADDRE centers including the 
California Department of Health and Human Services, Colorado Department 
of Public Health and Environment, Johns Hopkins University, the 
University of Pennsylvania, and the University of North Carolina at 
Chapel Hill. CDC National Center for Birth Defect and Developmental 
Disabilities will participate as the 6th site. The multi-site, 
collaborative study will be an epidemiological investigation of 
possible causes for the autism spectrum disorders.
    Data collection methods will consist of the following: (1) Medical 
and educational record review of the child participant; (2) medical 
record review of the biological mother of the child participant; (3) a 
packet sent to the participants with self-administered questionnaires 
and a buccal swab kit; (4) a telephone interview focusing on pregnancy-
related events and early life history (biological mother and/or primary 
caregiver interview); (5) a child development interview (for case 
participants only) administered over the telephone or in-person; (6) a 
developmental and physical exam of the child participant; (7) 
biological sampling of the child participant (blood and hair); and, (8) 
biological sampling of the biological parents of the child participant 
(blood only). OMB clearance is requested for the self administered 
questionnaires and buccal swab kit, the primary caregiver interview, 
and the child development interview. There is no cost to respondents 
other than their time.

                                       Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                 Average
                                                Number of       Number of      burden per     Total burden
                   Survey                      respondents    responses per   response  (in     (in hrs.)
                                                               respondent         hrs.)
----------------------------------------------------------------------------------------------------------- ---------
Cases:
    --Self administered questionnaires and              644               1             3.0            1932
     buccal swab kit.......................
    --Primary caregiver interview..........             644               1           40/60             429
    --Child development interview..........             644               1             3.0            1932
Controls:
    --Self administered questionnaires and             1288               1             3.0            3864
     buccal swab kit.......................
    --Primary caregiver interview..........            1288               1           40/60             859
    --Child development interview..........            1288               1             1.0            1288
                                            -----------------
        Total..............................  ..............  ..............  ..............          10,304
----------------------------------------------------------------------------------------------------------------


    Dated: June 21, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 05-13245 Filed 7-5-05; 8:45 am]
BILLING CODE 4163-18-P
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