38938 Federal Register / Vol. 70, No.

128 / Wednesday, July 6, 2005 / Notices

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

ESTIMATE OF ANNUALIZED BURDEN HOURS

Average
Number of
Number of burden per Total burden
Survey responses per
respondents response (in hrs.)
respondent (in hrs.)

Cases:
—Self administered questionnaires and buccal swab kit ......................... 644 1 3.0 1932
—Primary caregiver interview ................................................................... 644 1 40/60 429
—Child development interview ................................................................. 644 1 3.0 1932
Controls:
—Self administered questionnaires and buccal swab kit ......................... 1288 1 3.0 3864
—Primary caregiver interview ................................................................... 1288 1 40/60 859
—Child development interview ................................................................. 1288 1 1.0 1288

Total ................................................................................................... ........................ ........................ ........................ 10,304

Dated: June 21, 2005. CDC Assistant Reports Clearance Background and Brief Description
Joan F. Karr, Officer, 1600 Clifton Road, MS–D74, CDC has been monitoring the
Acting Reports Clearance Officer, Centers for Atlanta, GA 30333 or send an e-mail to occurrence of serious birth defects and
Disease Control and Prevention. omb@cdc.gov. genetic diseases in Atlanta since 1967
[FR Doc. 05–13245 Filed 7–5–05; 8:45 am] Comments are invited on: (a) Whether through the Metropolitan Atlanta
BILLING CODE 4163–18–P the proposed collection of information Congenital Defects Program (MACDP).
is necessary for the proper performance The MACDP is a population-based
of the functions of the agency, including surveillance system for birth defects in
DEPARTMENT OF HEALTH AND whether the information shall have the 5 counties of Metropolitan Atlanta.
HUMAN SERVICES practical utility; (b) the accuracy of the Its primary purpose is to describe the
agency’s estimate of the burden of the spatial and temporal patterns of birth
Centers for Disease Control and proposed collection of information; (c) defects occurrence and serve as an early
Prevention ways to enhance the quality, utility, and warning system for new teratogens.
clarity of the information to be From 1993 to 1996, the Division of Birth
[60 Day–05–0010]
collected; and (d) ways to minimize the Defects and Developmental Disabilities
Proposed Data Collections Submitted burden of the collection of information (DBDDD) conducted the Birth Defects
for Public Comment and on respondents, including through the Risk Factor Surveillance (BDRFS) study,
Recommendations use of automated collection techniques a case-control study of risk factors for
or other forms of information selected birth defects. Infants with birth
In compliance with the requirement technology. Written comments should defects were identified through MACDP
of section 3506(c)(2)(A) of the be received within 60 days of this and maternal interviews and clinical/
Paperwork Reduction Act of 1995 for notice. laboratory tests were conducted on
opportunity for public comment on approximately 300 cases and 100
proposed data collection projects, the Proposed Project
controls per year. Controls were selected
Centers for Disease Control and The National Birth Defects Prevention from among normal births in the same
Prevention (CDC) will publish periodic Study (OMB 0920–0010)—Extension— population. In 1997 the BDRFS became
summaries of proposed projects. To The Division of Birth Defects and the National Birth Defects Prevention
request more information on the Developmental Disabilities (DBDDD), Study (NBDPS). The major components
proposed projects or to obtain a copy of National Center on Birth Defects and of the study did not change.
the data collection plans and Developmental Disabilities (NCBDDD), The NBDPS is a case-control study of
instruments, call 404–371–5983 and Centers for Disease Control and major birth defects that includes cases
send comments to Seleda Perryman, Prevention (CDC). identified from existing birth defect

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 Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Notices 38939

surveillance registries in ten states Parents are asked to collect cheek cells interactions for a broad range of
(including metropolitan Atlanta). from themselves and their infants for carefully classified birth defects.
Control infants are randomly selected DNA testing. Information gathered from This request is submitted to obtain
from birth certificates or birth hospital both the interviews and the DNA OMB clearance for three additional
records. Mothers of case and control specimens will be used to study years. There is no cost to respondents
infants are interviewed using a independent genetic and environmental
other than their time.
computer-assisted telephone interview. factors as well as gene-environment

ESTIMATE OF ANNUALIZED BURDEN HOURS

Average bur-
Number of Frequency of Annual burden
Type of burden den/response
respondents response (in hours)
(in hours)

NBDPS case/control interview ......................................................................... 400 1 1 400

Biologic specimen collection ............................................................................ 1,200 1 10/60 200

Total .......................................................................................................... ........................ ........................ ........................ 600

Dated: June 21, 2005. 1. Assessing the stage of HIV disease these reports truly indicate access to
Joan F. Karr, at initial diagnosis among a cohort of care. This proportion has not been
Acting Reports Clearance Officer, Centers for newly diagnosed HIV-infected persons, reliably estimated by national
Disease Control and Prevention. over the age of 13, using routine and surveillance data. Some reporting areas
[FR Doc. 05–13246 Filed 7–5–05; 8:45 am] augmented laboratory and clinical report a high proportion (greater than 75
BILLING CODE 4163–18–P information. percent) of newly diagnosed cases with
2. Better characterizing CD4 count CD4 and/or VL results within 12 months
and VL, and correlating this laboratory of diagnosis.
DEPARTMENT OF HEALTH AND information with available data on OIs. The factors that contribute to the
HUMAN SERVICES If, after complete enumeration of lab ability of lower morbidity areas to report
and OI information, OIs add little to completely has not been fully examined,
Centers for Disease Control and nothing to help stage HIV disease, then but may be due to their ability to
Prevention future surveillance practices may be conduct active case finding and medical
streamlined. record abstraction. These practices may
Augmenting Laboratory Outcomes in 3. Identifying surveillance practices have national surveillance policy
HIV Assessment (ALOHA) (e.g., laboratory reporting requirements, implications. Since lab reporting data is
electronic lab reporting, and program critical to the expectations of the
Announcement Type: Supplemental policies or organization) that affect the
(04017). Morbidity Monitoring Project (MMP), an
completeness and accuracy of area will be sought to provide validation
Funding Opportunity Number: surveillance laboratory data.
AA120. of lab reporting as a marker for receiving
4. Assessing lab reporting as a marker
Catalog of Federal Domestic health care, and to collect information
for access and adherence to care
Assistance Number: 93.944. about reasons for no lab testing and the
following HIV diagnosis.
Key Dates: 5. Identifying correlates for not being inability to link a person to care.
Application Deadline: August 5, 2005. in care, as indicated by the presence or Lastly, ALOHA will include at least
absence of laboratory reports. one area that will match its HIV/AIDS
I. Funding Opportunity Description case registry to infectious disease
6. Systematically evaluating the
Authority: This program is authorized availability of clinical and laboratory databases to identify, apart from
under sections 317(k)(2) and 318b of the data on the prevalence of common co- medical record review, OIs that
Public Health Service Act (42 U.S.C. morbid conditions (e.g., hepatitis B, occurred six months before and after
Sections 247b(k)(2) and 247c), as hepatitis C, tuberculosis, and cancer) HIV diagnosis. Examples of these
amended. that are associated with risk factors for databases include the National
Purpose: CD4+ T-lymphocyte (CD4) HIV infection and influence the clinical Electronic Disease Surveillance System
and viral load (VL) tests are used to course of HIV disease. Data on these (NEDSS); cancer, hepatitis or
stage disease and, when opportunistic conditions will be compared to levels of tuberculosis registries; or prescription
infections (OI) are present, to guide CD4 and VL to assess the effects of co- medication databases (e.g., Medicaid or
therapeutic decisions. Because CD4 and morbid conditions on levels of AIDS Drug Assistance Program).
VL testing should be performed immunosuppression at the time of HIV As part of this project, participating
throughout the course of HIV disease, diagnosis. areas will conduct their usual
reporting of these lab tests has been A variety of HIV/AIDS reporting areas surveillance activities for information
used as a marker for whether HIV- with different surveillance practices and on CD4 and VL lab results and OIs.
infected persons are receiving procedures will be sought for ALOHA. These activities include active case
healthcare. Augmenting Laboratory This project will attempt to include an surveillance, medical record review and
Outcomes in HIV Assessment (ALOHA) area that currently warehouses lab data extraction for newly diagnosed
will augment routine HIV/AIDS results, specifically CD4, in a separate cases (over the age of 13). When no lab
surveillance data collection for the lab results database, and does not report result is received by the HIV/AIDS
purpose of assessing the completeness this information to the national HIV/ surveillance program, ongoing active
and validity of laboratory (i.e., CD4 AIDS surveillance system. The case follow-up will be needed to
count and VL) and OI information. This completeness of reporting for CD4 determine case disposition and record
will be accomplished by the following: results will be assessed to determine if specific categorical information, such as

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