[Federal Register Volume 61, Number 82 (Friday, April 26, 1996)]
[Notices]
[Pages 18609-18611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10356]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[INFO-96-14]


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 the CDC Reports 
Clearance Officer on (404) 639-7090.
    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 for other 
forms of information technology. Send comments to Wilma Johnson, CDC 
Reports Clearance Officer, 1600 Clifton Road, MS-D24, Atlanta, GA 
30333. Written comments should be received within 60 days of this 
notice.

Proposed Projects

    1. Studies of Adverse Reproductive Outcomes in Female Occupational 
Groups--(0920-0367)--Revised--An estimated 50,000 to 60,000 chemicals 
are in common use throughout society today and hundreds of new 
chemicals are introduced each year. Yet the list of environmental 
chemicals and agents that have been investigated to determine whether 
they have adverse effects on reproductive health is still limited. With 
the growing number of women in the work force, it is becoming 
increasingly important to evaluate the potential female reproductive 
health effects of occupational and physical agents.
    In this program, NIOSH is planning to undertake a series of five 
studies to focus on potential reproductive effects of chemical and 
physical agents in the workplace. In the studies planned under this 
program, the reproductive health of a group of female workers exposed 
to the agent of interest, will be compared to the reproductive health 
of a group of working women with no occupational exposure to known or 
suspected reproductive toxicants.
    For all studies, data from company personnel records containing 
demographic, and work history information will be used to estimate 
workplace exposures. Each woman will be asked to complete a telephone 
questionnaire on reproductive history and other factors (such as 
cigarette smoking) that may influence reproductive function. Each 
questionnaire will take approximately 60 minutes to complete. Medical 
records will be requested to confirm adverse reproductive outcomes 
reported by the participants. The risk of adverse reproductive outcomes 
between the two groups of women will then be compared.
    The first study to be conducted under this program will be a study 
of reproductive disorders among female flight attendants. Approximately 
66,000 flight attendants are currently employed by U.S. commercial 
airlines and are potentially exposed to ionizing radiation and 
disruption of circadian rhythms, two exposures that may adversely 
affect reproductive function. The other studies to be conducted under 
this program have not yet been determined. The total cost to 
respondents is estimated at 102,000.00

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                                                                              No. of    Avg. burden/    Total   
                         Respondents                             No. of     responses/    response   burden  (in
                                                              respondents   respondent   (in hrs.)      hrs.)   
----------------------------------------------------------------------------------------------------------------
Workers.....................................................        6,200            1            1        6,200
Medical providers...........................................        1,200            1          0.5          600
                                                             ---------------------------------------------------
      Total.................................................  ...........  ...........  ...........        6,800
----------------------------------------------------------------------------------------------------------------

    2. Coal Mine Dust Personal Sampling Systems--(0920-148)--
Extension--This project, mandated under the Federal Mine Safety and 
Health Act of 1977 (Pub. L. 91-173, as amended by Pub. L. 95-164), 
involves conducting evaluations and tests on coal mine dust personnel 
sampling units (CMDPSUs) and issuing certifications for those CMDPSUs 
which meet or exceed all applicable requirements listed in 30 CFR Part 
74. It also requires conducting audits of new ``off-the-shelf'' CMDPSUs 
certified under these regulations to determine compliance, evaluating 
those CMDPSUs sent to NIOSH as field problems, and responding to 
technical assistance requests. The total cost to respondents is 
estimated at $11,000.

[[Page 18610]]



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                                                                              No. of    Avg. burden/    Total   
                         Respondents                             No. of     responses/    response    burden (in
                                                              respondents   respondent   (in hrs.)      hrs.)   
----------------------------------------------------------------------------------------------------------------
Manufacturer................................................            1            1           39           39
                                                             ---------------------------------------------------
      Total.................................................  ...........  ...........  ...........           39
----------------------------------------------------------------------------------------------------------------

    3. Monthly Vital Statistics Report--(0920-0213)--Extension--The 
compilation of national vital statistics dates back to the beginning of 
this century and has been conducted since 1960 by the Division of Vital 
Statistics of the National Center for Health Statistics, CDC. The 
collection of the data is authorized by 42 USC 242k. The Monthly Vital 
Statistics Report provides estimates of monthly occurrences of births, 
deaths, infant deaths, marriages, and divorces following the end of 
each month. Similar data have been published since 1937, and are the 
sole source of these data at the national level. The data are widely 
used by the Department of Health and Human Services and by other 
government, academic, and private research organizations in tracking 
changes in trends of vital events. The data are essential to the U. S. 
Bureau of the Census as input to their various population estimates. 
They are also used each month by the Bureau of Economic Analysis, 
Department of Commerce, to extrapolate an element of the Gross National 
Product.
    Respondents for the Monthly Vital Statistics Report and the Monthly 
Report on Marriages, Divorces and Annulments are registration officials 
in each state, the District of Columbia, and New York City. Respondents 
for the Monthly Marriage and Divorce Statistical Report forms are 60 
local (county) officials in New Mexico who record marriages occurring 
and divorces and annulments granted in each county of New Mexico. The 
are no direct costs to respondents; the data are routinely available in 
each reporting office as a by-product of ongoing activities.

----------------------------------------------------------------------------------------------------------------
                                                                              No. of    Avg. burden/    Total   
                         Respondents                             No. of     responses/    response   burden  (in
                                                              respondents  respondents   (in hrs.)      hrs.)   
----------------------------------------------------------------------------------------------------------------
State registration officials: Monthly Vital Statistics                                                          
 Report.....................................................           52           12          0.1         62.4
State registration officials: Monthly Report on Marriages,                                                      
 Divorces, and Annulments...................................           52           12          0.1         62.4
County registration officials: New Mexico: Monthly Marriage                                                     
 and Divorce Statistical Report Forms.......................           60           12          0.1           72
                                                             ---------------------------------------------------
      Total.................................................  ...........  ...........  ...........          197
----------------------------------------------------------------------------------------------------------------

    4. Standardized Reporting System and Associated Epidemiologic 
Investigations of Occupationally Related Infection with Human 
Immunodeficiency Virus in Health Care and Public Safety Settings (0920-
0286)--Extension--The Surveillance Branch, Division of HIV/AIDS 
Prevention, National Center for HIV, STD, and TB Prevention, Centers 
for Disease Control and Prevention plans to continue surveillance of 
health care workers (HCWs) and public safety workers who may have 
occupationally acquired human immunodeficiency virus (HIV) infection. 
This reporting system, initiated September 1991, collects essential 
scientific information on workers with occupationally acquired HIV 
infection, the exposures that led to infection, and the natural history 
of HIV infection. State and local health departments will investigate 
reported cases of HCWs and others with HIV infection for whom HIV may 
have been transmitted through occupational exposures. With the consent 
of the infected worker, the health department will collect information 
including: HIV test results; whether the route of exposure was 
percutaneous, mucous membrane, or skin; the type of device and 
procedure associated with the exposure; use of postexposure 
chemoprophylaxis; and other behavioral and transfusion risk factors for 
HIV infection. Reports, without identifying information, will be 
forwarded from the health department to CDC. The total cost to 
respondents is estimated at $1,250.

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                                                                                          Average               
                                                                 No. of       No. of      burden /      Total   
                         Respondents                          respondents   responses/    response   burden  (in
                                                                            respondent   (in hrs.)      hrs.)   
----------------------------------------------------------------------------------------------------------------
Workers who may have occupation- ally acquired HIV infection          100            1          0.5           50
                                                             ---------------------------------------------------
      Total.................................................  ...........  ...........  ...........           50
----------------------------------------------------------------------------------------------------------------

    5. Development and Implementation of a Comprehensive Evaluation for 
Project DIRECT (Diabetes Intervention: Reaching and Educating 
Communities Together--NEW--Diabetes mellitus is more prevalent among 
African-Americans than whites, and African-Americans with diabetes are 
more likely to suffer its devastating complications. Compared to 
whites, African-Americans are more likely to develop blindness and end-
stage renal disease and are more likely to have amputations. In 
addition, cardiovascular risk factors are more prevalent among African-
Americans than whites and African-Americans are more likely to die with 
diabetes than are whites. In response to this disparity, the Centers 
for Disease Control and Prevention (CDC) has launched a large-scale 
community intervention trial known as Project DIRECT (Diabetes 
Intervention: Reaching and Educating Communities Together). Based in 
Raleigh, North Carolina, and sponsored by CDC's Division of Diabetes 
Translation, Project DIRECT will serve as a model for multilevel 
community-based diabetes prevention and control programs for urban 
African-Americans.
    This evaluation will determine the effect of (1) diabetes care; (2) 
outreach, and (3) health promotion interventions in the targeted 
community and compare this effect to a control community. The 
intervention activities focus on the African-American population of a 
geographically defined area of southeast Raleigh, North Carolina. The 
control community

[[Page 18611]]

is Greensboro, North Carolina. The populations consist primarily of 
African-Americans. Health care providers will be identified and 
solicited from practicing physicians in Raleigh and Greensboro.
    The survey will be conducted in four phases. Phase I will randomly 
identify and solicit participation from household members with and 
without diabetes from the control and intervention communities. In 
Phase II, participants with and without diabetes will be randomly 
selected and administered the survey questionnaire upon granting 
informed consent. During Phase III, persons with diabetes will undergo 
a brief physical exam that will consist of physical measures for 
height, weight, blood pressure, and body mass index. In addition, 
collection of a venous blood sample and urine sample will be performed. 
In Phase IV, interviewers will administer a questionnaire to primary 
care physicians about their knowledge, attitude and practice patterns 
for caring for persons with diabetes. This study will undergo 
Institutional Review Board reviews and comply with human subject 
assurances in accordance with federal regulations. The total cost to 
respondents is estimated at $41,160.

----------------------------------------------------------------------------------------------------------------
                                                                              No. of    Avg. burden/    Total   
                         Respondents                             No. of     responses/    response   burden  (in
                                                              respondents   respondent   (in hrs.)      hrs.)   
----------------------------------------------------------------------------------------------------------------
Households..................................................        8,000            1       0.3333        2,666
Persons without diabetes....................................        1,600            1          0.5          800
Persons with diabetes.......................................          600            1          0.5          300
Primary Care Physicians.....................................          140            1          0.5           70
                                                             ---------------------------------------------------
      Total.................................................  ...........  ...........  ...........        3,836
----------------------------------------------------------------------------------------------------------------

    6. National Disease Surveillance Program I--(0920-0009)--
Extension--Formal surveillance of 21 separate reportable diseases has 
been ongoing to meet the public demand and scientific interest for 
accurate, consistent epidemiologic data. The diseases include: HIV/
AIDS, bacterial meningitis, dengue, idiopathic CD4+ T-lymphocytopenia, 
kawasaki syndrome, legionellosis, Hansen's Disease, lyme disease, 
malaria, pertussis, plague, poliomyelitis, psittacosis, Reye Syndrome, 
Rocky Mountain Spotted Fever, Tetanus, Toxic Shock Syndrome, 
toxocariasis, trichinosis, typhoid fever, and viral hepatitis. Case 
report forms enable CDC to collect demographic, clinical, and 
laboratory characteristics of cases of these diseases. This information 
is used to direct epidemiologic investigations, to identify and monitor 
trends in reemerging infectious diseases or emerging modes of 
transmission, to search for possible causes or sources of the diseases, 
and to develop guidelines for prevention and or treatment. It is also 
used to recommend target areas in most need of vaccinations for certain 
diseases and to determine development of drug resistance.
    Because of the distinct nature of each of the diseases, the number 
of cases reported annually is different for each. The total cost to 
respondents is estimated at $818,184.

----------------------------------------------------------------------------------------------------------------
                                                                              No. of    Avg. burden     Total   
                         Respondents                             No. of     responses/    response   burden  (in
                                                              respondents   respondent   (in hrs.)      hrs.)   
----------------------------------------------------------------------------------------------------------------
Health Care Workers.........................................      125,214            1          0.5       34,091
                                                             ---------------------------------------------------
      Total.................................................  ...........  ...........  ...........       34,091
----------------------------------------------------------------------------------------------------------------

    Dated: April 22, 1996.
Wilma G. Johnson,
Acting Associate Director for Policy Planning and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 96-10356 Filed 4-25-96; 8:45 am]
BILLING CODE 4163-18-P