Proposed Data Collections Submitted for Public Comment and Recommendations, 58396-58397 [2012-23194]

Download as PDF 58396 Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices ESTIMATES OF ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden hours Parent category Form name Parent Group 1 ................................. Parent Groups 1, 2, 3, and 4 ............ Focus Group Guide .......................... Focus group recruitment letter ......... Interviewer guide .............................. Interview recruitment letter ............... Survey .............................................. 36 50 35 50 230 1 1 1 1 1 1.5 5/60 1 5/60 10/60 54 4 35 4 38 Total Burden Hours ................... ........................................................... ........................ ........................ ........................ 135 Parent Groups 2 and 3 ..................... Dated: September 14, 2012. Ron A. Otten, Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2012–23197 Filed 9–19–12; 8:45 am] BILLING CODE 4163–18–P Proposed Project Exposure Assessment and Epidemiological Study of U.S. Workers Exposed to Carbon Nanotubes and Carbon Nanofibers—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–12–12RS] mstockstill on DSK4VPTVN1PROD with NOTICES 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 404–639–7570 or send comments to Kimberly S. Lane, at 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an email to omb@cdc.gov. 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 or other forms of information technology. Written comments should be received within 60 days of this notice. VerDate Mar<15>2010 16:11 Sep 19, 2012 Jkt 226001 The mission of the National Institute for Occupational Safety and Health (NIOSH) is to promote safety and health at work for all people through research and prevention. The Occupational Safety and Health Act of 1970, Public Law 91–596 (Section 20[a][1] authorizes NIOSH to conduct research to advance the health and safety of workers. In this capacity, NIOSH will conduct an exposure assessment and epidemiological study of U.S. carbon nanotube (CNT) and carbon nanofiber (CNF) workers. At present, because of the newness of the technology, much of the occupational exposure to engineered nanomaterials occurs at the research and development (R&D) or pilot scale. There have been few reliable surveys of the size of the workforce exposed to nanomaterials. Health effects from exposure to nanomaterials are uncertain, but may be more severe than from larger-sized particles of the same material. This is due to the small size, high surface area per unit mass (i.e., specific surface area) or (in some cases) high aspect ratio of nanomaterials. Carbon nanotubes and nanofibers are among the nanomaterials of greatest interest from a public health perspective because of their potentially asbestiform properties (e.g., high aspect ratio) and toxicological evidence of possible fibrogenic, inflammatory, and clastogenic damage resulting from exposures at occupationally relevant levels. In addition, the useful properties of CNT and CNF have rendered them among the first nanomaterials to be commercially exploited in manufacturing settings. Thus, an PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 epidemiologic study to determine whether early or late health effects occur from occupational exposure to CNT and CNF is warranted. The proposed research is a crosssectional study of the small current U.S. workforce involved with CNT and CNF in manufacturing and distribution, to be conducted in the following phases: 1) Industrywide exposure assessment study to evaluate worker exposure and further develop and refine measurement methods for CNT and CNF. This component will refine sampling and analysis protocols previously developed for the detection and quantification of CNT and CNF in US workplaces. 2) A cross-sectional study relating the best metrics of CNT and CNF exposure to markers of early pulmonary or cardiovascular health effects. After the sampling and analysis protocols have been established to measure CNT and CNF, an industrywide study of the association between exposure and health effects will be conducted. Medical examinations will be conducted and several biomarkers of early effect (for pulmonary fibrosis, cardiovascular disease, and genetic damage) will be measured in blood and sputum for workers exposed to a range of CNT and CNF levels. The study will include a questionnaire with a three-fold purpose: (1) To determine whether study participants have any contraindications for certain medical procedures to be conducted (spirometry and sputum induction), (2) to assist in interpretation of the biomarker results, and (3) to inquire about current and past exposure to CNT, CNF, and other chemicals, dusts, and fumes. The questionnaire will be given by NIOSH personnel as a computer-assisted personal interview (CAPI). After administration of the CAPI, medical examinations will be conducted to evaluate pulmonary function (via spirometry) and blood pressure, and sputum and blood will be collected. Statistical analyses will be conducted to determine the nature of the relation between exposure to CNT E:\FR\FM\20SEN1.SGM 20SEN1 58397 Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices and CNF and these biomarkers of early effect, considering potential confounding factors such as smoking, age, gender, and workplace coexposures, including non-engineered ultrafine particles. The proposed project supports the NIOSH legislatively mandated industrywide studies program that conducts epidemiological and exposure study will be carried out during the participants’ regular work shift. There is no cost to respondents or their employers other than their time. We estimate that the average burden per response to be 22 minutes, and that the total burden to all respondents will be 37 hours (see table below). assessment research studies to identify the occupational causes of disease in the working population and their offspring and to effectively communicate study results to workers, scientists, industry, and the public. The questionnaire will be administered one time only, at the worksite, to 100 workers involved in the production and use of CNT or CNT. The ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Number of respondents Respondents Average burden per response (in hours) Total burden (in hours) Nanomaterials Workers ................................................................................... 100 1 22/60 37 Total .......................................................................................................... ........................ ........................ ........................ 37 Dated: September 14, 2012. Ron A. Otten, Director, Office of Scientific Integrity (OSI), Office of the Associate Director for Science (OADS), Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2012–23194 Filed 9–19–12; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Healthcare Infection Control Practices Advisory Committee (HICPAC) mstockstill on DSK4VPTVN1PROD with NOTICES In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting for the aforementioned committee: Times and Dates: 9:00 a.m.–5:00 p.m., October 11, 2012; 9:00 a.m.–12:00 p.m., October 12, 2012 Place: Renaissance Washington, DC Dupont Circle Hotel, City Center Ballroom, 1143 New Hampshire Avenue NW., Washington, District of Columbia 20037. Status: Open to the public, limited only by the space available. Please register for the meeting at www.cdc.gov/hicpac. Purpose: The Committee is charged with providing advice and guidance to the Secretary, Department of Health and Human Services (HHS); the Director, Centers for Disease Control and Prevention (CDC); the Deputy Director, Office of Infectious Diseases (OID), CDC; and the Director, National Center for Emerging and Zoonotic Infectious Disease (NCEZID), CDC, regarding (1) the practice of infection control; (2) strategies for surveillance, prevention, and control of healthcare-associated infections (e.g., nosocomial infections) antimicrobial resistance and related events in settings where healthcare is provided, including VerDate Mar<15>2010 16:11 Sep 19, 2012 Jkt 226001 hospitals, ambulatory and long-term care facilities, and home health agencies; and (3) periodic updating of existing guidelines, development of new guidelines, guideline evaluation; and other policy statements regarding the prevention of healthcareassociated infections an healthcare-related conditions. Matters To Be Discussed: The agenda will include updates on CDC’s activities for healthcare associated infections (HAI), an update on the draft guideline for prevention of infections among patients in neonatal intensive care units (NICU), draft guideline for the prevention of surgical site infections, draft guidance for facility adjudication of infection data, and an update from the HICPAC surveillance working group. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Erin Stone, M.S., HICPAC, Division of Healthcare Quality Promotion, NCEZID, CDC, l600 Clifton Road, NE., Mailstop A–07, Atlanta, Georgia 30333 Telephone (404) 639–4045. Email: hicpac@cdc.gov The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: September 12, 2012. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2012–23193 Filed 9–19–12; 8:45 am] BILLING CODE 4163–18–P PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention—Ethics Subcommittee (ES) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned subcommittee: Time and Date: 8:30 a.m.–2:30 p.m., EDT, Thursday, October 11, 2012. Place: CDC, Thomas R. Harkin Global Communications Center, Distance Learning Auditorium, 1600 Clifton Road, NE., Atlanta, GA 30333. This meeting is also available by teleconference. Please dial (877) 928–1204 and enter code 4305992. Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 60 people. To accommodate public participation in the meeting, a conference telephone line will be available. The public is welcome to participate during the public comment period. The public comment period is tentatively scheduled for 2 p.m.–2:10 p.m. Purpose: The ES will provide counsel to the ACD, CDC, regarding a broad range of public health ethics questions and issues arising from programs, scientists and practitioners. Matters To Be Discussed: Agenda items will include the following topics: Ethical considerations relating to use of travel restrictions for the control of communicable diseases; addition of ethics standards to the accreditation process for public health departments; approaches for evaluating the impact of public health ethics activities; progress on developing practical tools to assist state, tribal, local, and territorial health departments in their efforts to address public health ethics challenges; and strategies for E:\FR\FM\20SEN1.SGM 20SEN1

Agencies

[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Notices]
[Pages 58396-58397]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23194]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-12-12RS]


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 404-639-7570 or 
send comments to Kimberly S. Lane, at 1600 Clifton Road, MS-D74, 
Atlanta, GA 30333 or send an email to omb@cdc.gov.
    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 or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Exposure Assessment and Epidemiological Study of U.S. Workers 
Exposed to Carbon Nanotubes and Carbon Nanofibers--New--National 
Institute for Occupational Safety and Health (NIOSH), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    The mission of the National Institute for Occupational Safety and 
Health (NIOSH) is to promote safety and health at work for all people 
through research and prevention. The Occupational Safety and Health Act 
of 1970, Public Law 91-596 (Section 20[a][1] authorizes NIOSH to 
conduct research to advance the health and safety of workers. In this 
capacity, NIOSH will conduct an exposure assessment and epidemiological 
study of U.S. carbon nanotube (CNT) and carbon nanofiber (CNF) workers.
    At present, because of the newness of the technology, much of the 
occupational exposure to engineered nanomaterials occurs at the 
research and development (R&D) or pilot scale. There have been few 
reliable surveys of the size of the workforce exposed to nanomaterials. 
Health effects from exposure to nanomaterials are uncertain, but may be 
more severe than from larger-sized particles of the same material. This 
is due to the small size, high surface area per unit mass (i.e., 
specific surface area) or (in some cases) high aspect ratio of 
nanomaterials. Carbon nanotubes and nanofibers are among the 
nanomaterials of greatest interest from a public health perspective 
because of their potentially asbestiform properties (e.g., high aspect 
ratio) and toxicological evidence of possible fibrogenic, inflammatory, 
and clastogenic damage resulting from exposures at occupationally 
relevant levels. In addition, the useful properties of CNT and CNF have 
rendered them among the first nanomaterials to be commercially 
exploited in manufacturing settings. Thus, an epidemiologic study to 
determine whether early or late health effects occur from occupational 
exposure to CNT and CNF is warranted.
    The proposed research is a cross-sectional study of the small 
current U.S. workforce involved with CNT and CNF in manufacturing and 
distribution, to be conducted in the following phases: 1) Industrywide 
exposure assessment study to evaluate worker exposure and further 
develop and refine measurement methods for CNT and CNF. This component 
will refine sampling and analysis protocols previously developed for 
the detection and quantification of CNT and CNF in US workplaces. 2) A 
cross-sectional study relating the best metrics of CNT and CNF exposure 
to markers of early pulmonary or cardiovascular health effects. After 
the sampling and analysis protocols have been established to measure 
CNT and CNF, an industrywide study of the association between exposure 
and health effects will be conducted. Medical examinations will be 
conducted and several biomarkers of early effect (for pulmonary 
fibrosis, cardiovascular disease, and genetic damage) will be measured 
in blood and sputum for workers exposed to a range of CNT and CNF 
levels.
    The study will include a questionnaire with a three-fold purpose: 
(1) To determine whether study participants have any contraindications 
for certain medical procedures to be conducted (spirometry and sputum 
induction), (2) to assist in interpretation of the biomarker results, 
and (3) to inquire about current and past exposure to CNT, CNF, and 
other chemicals, dusts, and fumes. The questionnaire will be given by 
NIOSH personnel as a computer-assisted personal interview (CAPI). After 
administration of the CAPI, medical examinations will be conducted to 
evaluate pulmonary function (via spirometry) and blood pressure, and 
sputum and blood will be collected. Statistical analyses will be 
conducted to determine the nature of the relation between exposure to 
CNT

[[Page 58397]]

and CNF and these biomarkers of early effect, considering potential 
confounding factors such as smoking, age, gender, and workplace co-
exposures, including non-engineered ultrafine particles.
    The proposed project supports the NIOSH legislatively mandated 
industrywide studies program that conducts epidemiological and exposure 
assessment research studies to identify the occupational causes of 
disease in the working population and their offspring and to 
effectively communicate study results to workers, scientists, industry, 
and the public.
    The questionnaire will be administered one time only, at the 
worksite, to 100 workers involved in the production and use of CNT or 
CNT. The study will be carried out during the participants' regular 
work shift. There is no cost to respondents or their employers other 
than their time. We estimate that the average burden per response to be 
22 minutes, and that the total burden to all respondents will be 37 
hours (see table below).

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
                   Respondents                      respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Nanomaterials Workers...........................             100               1           22/60              37
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............              37
----------------------------------------------------------------------------------------------------------------


    Dated: September 14, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate 
Director for Science (OADS), Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2012-23194 Filed 9-19-12; 8:45 am]
BILLING CODE 4163-18-P
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