[Federal Register Volume 63, Number 122 (Thursday, June 25, 1998)]
[Notices]
[Pages 34651-34652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16752]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[30DAY-16-98]


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 Officer at (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.

Proposed Projects

    1. Breast Cancer Incidence in an Occupational Cohort Exposed to 
Ethylene Oxide and in an Occupational Cohort Exposed to Polychlorinated 
Biphenyls (0920-0366)--National Institute for Occupational Safety and 
Health (NIOSH)--Extension--Breast cancer is the most common incident 
cancer among U.S. women, and the second leading cause of cancer 
mortality in U.S. women. Increasing numbers of women are employed 
outside the home, yet few studies of breast cancer etiology have 
addressed occupational and environmental chemical exposures, and

[[Page 34652]]

many cancer studies of industrial cohorts have excluded women. This 
study will provide information concerning: (1) the incidence of breast 
cancer in a cohort of women exposed to ethylene oxide (ETO), and (2) 
the incidence of breast cancer in a cohort of women exposed to 
polychlorinated biphenyls (PCBs). Both compounds are suspected breast 
carcinogens. These two cohorts have been previously assembled by NIOSH, 
and each represents the largest and best defined female study cohort in 
the U.S. for the respective exposure.
    All women in the existing NIOSH ethylene oxide cohort (n=9,929) and 
PCB cohort (13,736) will be enrolled in the study. For both cohorts, 
data from personnel records has been coded into a computer file 
containing demographic, and work history information. This information 
will be used to estimate workplace exposures. Vital status has been 
determined through automated data sources. Questionnaires are currently 
being mailed to each living cohort member to obtain information on 
breast cancer incidence and risk factors for breast cancer. For 
deceased cohort members, next-of-kin will be asked to provide this 
information. Other record sources such as death certificates and 
population-based cancer incidence registries will also be used to 
identify cancer cases. The diagnosis will be confirmed by medical 
records. Each questionnaire will take approximately 30 minutes to 
complete. Total annual burden hours are 12,500.

----------------------------------------------------------------------------------------------------------------
                                                                            Number of   Avg. burden/    Total   
                         Respondents                           Number of    responses/    response   burden  (in
                                                              respondents   respondent   (in hours)     hours)  
----------------------------------------------------------------------------------------------------------------
Workers.....................................................       23,000            1          .50       11,500
Medical providers...........................................        2,000            1          .50        1,000
----------------------------------------------------------------------------------------------------------------

    2. Tests and Requirements for Certification and Approval of 
Respiratory Protective Devices--42 CFR 84--Regulation--(0920-0109)--
Extension--The regulatory authority for the National Institute for 
Occupational Safety and Health (NIOSH) certification program for 
respiratory protective devices is found in the Mine Safety and Health 
Amendments Act of 1977 (30 U.S.C. 577a, 651 et seq., and 657(g)) and 
the Occupational Safety and Health Act of 1970 (30 U.S.C. 3, 5, 7, 811, 
842(h), 844). These regulations have, as their basis, the performance 
tests and criteria for approval of respirators used by millions of 
American construction workers, miners, painters, asbestos removal 
workers, fabric mill workers, and fire fighters. In addition to 
benefitting industrial workers, the improved testing requirements also 
benefit health care workers implementing the current CDC Guidelines for 
Preventing the Transmission of Tuberculosis. Regulations of the 
Environmental Protection Agency (EPA) and the Nuclear Regulatory 
Commission (NRC) also require the use of NIOSH-approved respirators.
    NIOSH, in accordance with implementing regulations 42 CFR 84: (1) 
Issues certificates of approval for respirators which have met improved 
construction, performance, and protection requirements; (2) establishes 
procedures and requirements to be met in filing applications for 
approval; (3) specifies minimum requirements and methods to be employed 
by NIOSH and by applicants in conducting inspections, examinations, and 
tests to determine effectiveness of respirators; (4) establishes a 
schedule of fees to be charged applicants for testing and 
certification, and (5) establishes approval labeling requirements. 
Total annual burden hours are 177,968.

----------------------------------------------------------------------------------------------------------------
                                                                                          Average               
                                                               Number of    Number of     burden/       Total   
               Respondents (section/data type)                respondents   responses/    response   burden  (in
                                                                            respondent   (in hours)     hours)  
----------------------------------------------------------------------------------------------------------------
84.11/Applications..........................................           56         14.0        63.56       49,831
84.33/Labeling..............................................           56         14.0         1.54        1,207
84.35/Modifications.........................................           56         14.0        79.45       62,289
84.41/Reporting.............................................           56         14.0        22.70       17,797
84.43/Record keeping........................................           56         14.0        56.75       44,492
84.257/Labeling.............................................           56         14.0         1.50        1,176
84.1103/Labeling............................................           56         14.0         1.50        1,176
----------------------------------------------------------------------------------------------------------------

    Dated: June 18, 1998.
Charles W. Gollmar,
Acting Associate Director for Policy Planning and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 98-16752 Filed 6-24-98; 8:45 am]
BILLING CODE 4163-18-P