[Federal Register Volume 61, Number 153 (Wednesday, August 7, 1996)]
[Notices]
[Pages 41164-41165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20070]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30 DAY-18]
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
the CDC Reports Clearance Office on (404) 639-7090. Send written
comments to CDC, Desk Officer, Human Resources and Housing Branch, New
Executive Office Building, Room 10235, Washington, DC 20503. Written
comments should be received within 30 days of this notice.
The following requests have been submitted for review since the
last publication date on August 2, 1996.
Proposed Projects
1. Case-Control Study of the Effect of Total Dietary Folate Intake
on the Clinical Manifestation of Vitamin B 12 Deficiency--New--
Fortification of grain products with folic acid has been recommended to
increase the intake of folate by women of reproductive age in order to
decrease the risk of neural tube birth defects. Fortification high
enough to increase the passive consumption of folic acid to the
recommended level of 400 ug/day for all women would increase the
consumption by some segments of the population to well over the
presumed safe upper limit of 1000 ug/day. There is concern, based on
case reports, that excess folate consumption may delay the diagnosis of
vitamin B 12 deficiency, especially in the elderly. Delayed diagnosis
of B 12 deficiency may lead to the development of neuropsychiatric
signs and symptoms, some of which may be irreversible. There is no
population-based estimate of the prevalence of B 12 deficiency among
the elderly, nor is there any population-based data on the frequency
with which diagnosis of B 12 deficiency is complicated by folate
intake. The Food and Drug Administration has postponed folate
fortification pending more data on the potential risks of high levels
of folate consumption for the general population.
This is a pilot study to determine the size, feasibility, cost and
duration of a population-based survey; the population-based survey
would estimate the prevalence of vitamin B 12 deficiency in the general
population and estimate the impact of folate intake on its diagnosis.
This information is needed to assess the risk that may be posed by high
levels of fortification of the food supply with folate.
The proposed pilot study will seek to identify new cases of B 12
deficiency from the computerized laboratory records of a health
maintenance organization, determine the nature of the clinical
presentation of the cases by medical record review, and evaluate the
association of folic acid intake with type of clinical presentation by
dietary assessment. 70 individuals with B 12 deficiency and 70 normal
controls will participate in a telephone interview about their diet and
use of nutritional supplements in the year preceding the diagnosis.
------------------------------------------------------------------------
Average
burden/
Respondents No. of Responses/ response
respondents respondent (in
hrs.)
------------------------------------------------------------------------
Cases w/B 12 deficiency.............. 70 1 1
Normal controls...................... 70 1 1
------------------------------------------------------------------------
The total annual burden is 140.
2. Supplement to HIV/AIDS Surveillance (SHAS)--Extension--(0920-
0262) There continues to be significant interest from public health,
community, minority groups, and affected groups in obtaining more
information on persons with HIV/AIDS infection. Since 1989, the Centers
for Disease Control and Prevention (CDC), in collaboration with 12
state and local health agencies, has collected data through the
national Supplemental HIV/AIDS Surveillance (SHAS) project. The
objective of this project is to obtain increased descriptive
information on persons with newly reported HIV and AIDS infections,
including socioeconomic characteristics, risk behaviors, use of health
care services, women's reproductive history and children's health, and
information on disabilities. This information supplements information
that is routinely collected through national HIV/AIDS surveillance. The
information gained from SHAS is used to improve our understanding of
minority issues related to the epidemic of HIV, target educational
efforts to prevent transmission, and improve services for persons with
HIV disease.
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Average
Number of burden/
Respondents Number of responses/ response
respondents respondent (in
hrs.)
------------------------------------------------------------------------
Georgia.............................. 409 1 0.75
California........................... 325 1 .75
Michigan............................. 164 1 .50
New Mexico........................... 83 1 .75
Arizona.............................. 283 1 .75
Colorado............................. 168 1 .75
Connecticut.......................... 213 1 .75
Delaware............................. 202 1 .50
Florida.............................. 261 1 .50
So. Carolina......................... 206 1 .50
New Jersey........................... 224 1 .75
Washington........................... 146 1 .75
------------------------------------------------------------------------
The total annual is 1,806.
3. Examination of Barriers to Participant Compliance in a Flexible
Sigmoidoscopy Screening Program, Imperial Cancer Research Fund, United
Kingdom--New--As part of an existing screening program, there is
significant project savings in this initiative. Colorectal cancer
accounts for approximately 9% of all newly diagnosed cancer worldwide.
Of all cancer mortality in industrialized nations, colorectal cancer is
second only to lung cancer, with the U.S. and Great Britain among the
highest in this category. Despite increasing evidence that the early
diagnosis of colorectal
[[Page 41165]]
cancer through screening examination can significantly prevent and/or
reduce the burden of mortality, morbidity, and associated costs, rates
of participation in screening remain extremely poor. This study,
involving investigators at the Imperial Cancer Research Fund (ICRF) of
Great Britain, seeks to identify barriers associated with low
compliance in a mass, population-based colorectal cancer screening
trial utilizing flexible sigmoidoscopy.
The ICRF has a long history of conducting important mass screening
trials relative to cancer early detection and their investigators are
considered international experts in colorectal cancer screening.
Because the ICRF already has an ongoing population-based colorectal
screening program, significant project start-up and infrastructure cost
savings have been incorporated into this proposal. Subjects will
include randomly selected adults age 55-64 with no known history of
colorectal cancer in Glasgow.
The study involves assessment of demographic, environmental, and
psychosocial factors which may limit screening participation via
surveys and interviews. Informed consent will be obtained and a
complete explanation of all medical procedures will be given.
Phase I will involve initial identification, survey query, and
solicitation for screening. Phase II will involve telephone and
personal interviews, and Phase III will involve final data analysis.
Participation in this study is voluntary and subsequent screening,
follow-up and treatment, if indicated, will be provided at no cost to
participants. Informed consent will be obtained where appropriate and
oversight will be provided by federal and local institutional review.
------------------------------------------------------------------------
Average
Number of burden/
Respondents Number of responses/ response
respondents respondent (in
hrs.)
------------------------------------------------------------------------
Population-based sample of adults
aged 55-64.......................... 6,000 1 .016
Phase III............................ 400 1 .0330
------------------------------------------------------------------------
The total burden hours is 1133.
4. Cholera and Vibrio Illness Investigation Report Form--(0920-
0322)--Extension--The purpose of the Cholera and other Vibrio Illness
Investigation Report Form is to collect information on illness
occurring as a result of infection with Vibrio species. Vibrios are
important pathogens in the United States, and primary septicemia,
gastroenteritis, and wound infections have been associated with various
species. In particular, gastroenteritis and primary septicemia have
been associated with the consumption of undercooked shellfish, and
particularly with raw Gulf Coast oysters. Associations have also been
linked to wound infections with exposure of broken skin to seawater.
Most importantly, Vibrio cholera 01 is the organism responsible for
cholera, a severe, dehydrating diarrheal illness. Although infections
with Vibrio cholera 01 are notifiable in all states, an official report
form for this illness did not previously exist. The Vibrio Illness
Investigation Report Form is used to record information on all Vibrio-
related illness, as well as more detailed information on cholera
illness, which is currently a reportable disease in all states. The
form has a separate optional Seafood Investigation section to be
completed when applicable. The form provides a consolidated, systematic
method by which health departments can report such information, which
is then used to gain a better understanding of the incidence, etiology,
and epidemiology of all Vibrio-related illness occurring in the United
States.
Data columns have been added to, and comments space reduced on, the
form to facilitate data entry and reduce the burden. No change in the
frequency of reporting has occurred or is projected.
Most respondents are epidemiologists or nurses in the local health
department, but in some instances infection control nurses or
physicians might complete the form.
------------------------------------------------------------------------
Average
Number of burden/
Respondents Number of responses/ response
respondents respondent (in
hrs.)
------------------------------------------------------------------------
Local health department staff........ 90 1 0.33
Health care facility staff........... 45 1 0.33
Physicians........................... 15 1 0.33
------------------------------------------------------------------------
The total annual burden is 50.
5. Metropolitan Atlanta Birth Defect and Risk Factor Surveillance
Program--(0920-0010)--Reinstatement--Birth defects are the leading
cause of infant mortality in the United States, and they cause a great
deal of lifelong morbidity. One in 33 infants are born with a major
birth defect. Occasionally, medications of environmental agents have
been recognized as causes of birth defects, an example being the drug
thalidomide in the early 1960s. Unless surveillance of trends and
unusual patterns in birth defects is undertaken, new ``thalidomide''
may be introduced and fail to be recognized in a timely fashion. The
Metropolitan Atlanta Congenital Defects Program (MACDP) has conducted
such surveillance since 1967 using existing hospital and clinic medical
records.
The causes of the majority of birth defects, however, are not
known. Birth Defects Risk Factor Surveillance (BDRFS) (which began in
January 1993) attempts to find the causes of a selected subset of major
anomalies, using an ongoing case-control study approach. BDRFS draws
its cases from the data collected by MACDP and conducts in-depth
interviews with the parents of affected infants and a comparison set of
randomly selected parents of unaffected infants.
The objectives of these two activities are: (1) To conduct
surveillance for congenital anomalies in metropolitan Atlanta; (2) to
gain new information on causes of birth defects; (3) to further
evaluate factors already suspected of influencing the occurrence of
birth defects; and (4) to develop and test methods (including the use
of biologic markers of exposure and susceptibility) in birth defect
surveillance that would be exportable to other birth defects
surveillance systems.
------------------------------------------------------------------------
Average
Number of burden/
Respondents Number of responses/ response
respondents respondents (in
hrs.)
------------------------------------------------------------------------
Special (ad hoc) studies interview.. 300 1 1
BDRFS case/control interview........ 500 1 1
Biologic specimen collection w/wo
clinical exam...................... 800 1 0.60
------------------------------------------------------------------------
The total annual burden is 1280.
Dated: July 31, 1996.
Wilma G. Johnson,
Acting Associate Director for Policy Planning And Evaluation, Centers
for Disease Control and Prevention (CDC).
[FR Doc. 96-20070 Filed 8-6-96; 8:45 am]
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