Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices 18609

and application forms. The

announcement is also available through

the CDC home page on the Internet. The

address for the CDC home page is http:/

/www.cdc.gov.

If you have questions after reviewing

the contents of all the documents,

business management assistance may be

obtained from Maggie Slay, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–13, Atlanta, GA 30305,

telephone (404) 842- 6630, or

INTERNET address,

mcs9@ops.pgo1.em.cdc.gov.

Programmatic technical assistance

may be obtained from Sharon

Campolucci, Deputy Director, Division

of Health Studies, Agency for Toxic

Substances and Disease Registry, 1600

Clifton Road, NE., Mailstop E–31,

Atlanta, GA 30333, telephone (404)

639–6200, or INTERNET address,

ssc1@atsdhs2.em.cdc.gov.

Please Refer to Announcement Number

607 When Requesting Information and

Submitting an Application

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1)

referenced in the Introduction through

the Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512–1800.

Dated: April 22, 1996.

Claire V. Broome,

Deputy Administrator, Agency for Toxic

Substances and Disease Registry.

[FR Doc. 96–10362 Filed 4–25–96; 8:45 am]

BILLING CODE 4163–70–P

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

Respondents No. of respondents

No. of responses/respondent

Avg. burden/response

(in hrs.)

Total

burden

(in 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 ‘‘offthe-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.
18610 Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices

Respondents No. of respondents

No. of responses/respondent

Avg. burden/response

(in hrs.)

Total burden

(in 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.

Respondents No. of respondents

No. of responses/respondents

Avg. burden/response

(in hrs.)

Total

burden

(in 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.

Respondents No. of respondents

No. of responses/respondent

Average

burden

/response

(in hrs.)

Total

burden

(in 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 AfricanAmericans 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
Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices 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.

Respondents No. of respondents

No. of responses/respondent

Avg. burden/response

(in hrs.)

Total

burden

(in 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.

Respondents No. of respondents

No. of responses/respondentAvg. burden

response

(in hrs.)

Total

burden

(in 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

Food and Drug Administration

[Docket No. 96N–0010]

Agency Information Collection

Activities; Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995,

Federal agencies are required to publish

notice in the Federal Register

concerning each collection of

information and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

a survey of male and female consumers

regarding various formats for presenting

risk and benefit information in drug

labeling.

DATES: Submit written comments by

June 25, 1996.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. All

comments should be identified with the

docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Charity B. Smith, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1686.

SUPPLEMENTARY INFORMATION: Section

3506(c)(2)(A) of the Paperwork

Reduction Act of 1995 (44 U.S.C.

3506(c)(2)(A)) requires Federal agencies

to provide 60-day notice in the Federal

Register concerning each proposed

collection of information. ‘‘Collection of

information’’ is defined in 44 U.S.C.

3502(3) and 5 CFR 1320.3(c). To comply

with this requirement, FDA is

publishing notice of the proposed

collection of information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of