Proposed Data Collections Submitted for Public Comment and Recommendations

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

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Total................................................. ........... ........... ........... 6,800

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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

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Total................................................. ........... ........... ........... 39

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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.

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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

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Total................................................. ........... ........... ........... 197

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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

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Total................................................. ........... ........... ........... 50

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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.

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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

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Total................................................. ........... ........... ........... 3,836

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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.

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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

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Total................................................. ........... ........... ........... 34,091

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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