[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.

------------------------------------------------------------------------
                                                                 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]
BILLING CODE 4163-18-P