Proposed Data Collections Submitted for Public Comment and Recommendations, 1938-1939 [2012-474]

Download as PDF 1938 Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Notices 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 All Age Influenza Hospitalization Surveillance (Flu Hosp)—OMB 0920– 0806, revision Expiration March 31, 2012—National Center for Immunization and Respiratory Diseases (NCIRD), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC is requesting extension of an OMB-approved data collection instrument for monitoring laboratoryconfirmed influenza hospitalizations (OMB 0920–0806, Exp March 31, 2012). Previously, two separate OMB-approved tools were used for this project: one for pediatric influenza hospitalizations season (October 1 of the current year to April 30 of the following year) and transmit it to CDC on a weekly basis. Case reports are submitted as soon as possible after case identification and investigation. Timely reports to CDC allow for rapid identification of epidemics, outbreaks and affected groups so that preventive measures can be quickly taken, and pertinent recommendations and policies can be made. The Flu Hosp data are also used for making influenza vaccination recommendations and modeling the burden of influenza morbidity and mortality. The entire data collection instrument can be completed from review of the hospital medical records. The only exception is in regard to the influenza vaccination status which, if not available in the medical record, may involve an interview of the patient or patient proxy. Influenza vaccination status information is crucial for allowing CDC to assess the influenza vaccination program performance. The respondents for the data collection instrument are the Flu Hosp participating sites. There are no costs to respondents other than their time for participating. (persons <18 years of age) and one for adult cases. As many of the same questions were asked separately in both the pediatric and adult forms, the rationale for consolidating these forms into one instrument is to minimize paperwork at the state/site level. Using one collection tool should also decrease the likelihood of errors in information collection and entry, improve the timeliness of data transmission to CDC, and minimize the overall burden on respondents of information collection. The All Age Influenza Hospitalization Surveillance (Flu Hosp) project is part of the Emerging Infections Program (EIP). EIP is a CDC-state-academic institution collaborative network including California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon and Tennessee. The consolidated Flu Hosp information collection instrument will be used to more efficiently collect demographic and clinical information about laboratory-confirmed influenza hospitalizations among adults and children in a geographic- and population-defined area of the United States. EIP sites will continue collecting patient information during the influenza ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Type of respondents Form name Health Department ............................ All Age Influenza Hospitalization Surveillance Project Case Report Form. 10 400 15/60 1000 Total ........................................... ........................................................... ........................ ........................ ........................ 1000 Dated: January 6, 2012. Kimberly Lane, Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 2012–472 Filed 1–11–12; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention tkelley on DSK3SPTVN1PROD with NOTICES [60-Day–12–0828] 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 VerDate Mar<15>2010 16:26 Jan 11, 2012 Jkt 226001 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 Lane, CDC Reports Clearance Officer, 1600 Clifton Road, MS D–74, 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 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 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 National Adult Tobacco Survey (NATS) (OMB No. 0920–0828, exp. 10/ 31/2010)—Reinstatement with Changes—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC) and the Center for Tobacco Products (CTP), Food and Drug Administration (FDA). E:\FR\FM\12JAN1.SGM 12JAN1 1939 Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Notices Background and Brief Description Tobacco use remains the leading preventable cause of disease and death in the United States, resulting in approximately 440,000 deaths annually. Smokers die an average of 14 years earlier than non-smokers. Moreover, cigarette smoking costs more than $193 billion; $97 billion in lost productivity plus $96 billion in health care expenditures. Although the prevalence of current smoking among adults in the United States has declined significantly since 1964, in more recent years (2004 to 2010) these declines have slowed or stalled with 1 in 5 adults reporting current smoking. In addition, promotion of non-cigarette tobacco products is leading to increased diversity of tobacco product usage, including the use of multiple products. With passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) in 2009, the Food and Drug Administration is legally mandated to regulate tobacco products for the protection of public health. Congress passed the FSPTCA to discourage tobacco use among minors and young adults, to encourage cessation among adult smokers and to reduce the public health burden of tobacco related disease in the U.S. Under the Tobacco Control Act, FDA has been granted broad authority to use the best available science to develop and implement effective strategies to protect the public’s health. FDA authority includes setting and enforcing standards for system. While NATS has been redesigned to meet the critical data needs of the FDA, many of the measures are relevant to CDC’s National Tobacco Control Program (NTCP), and CDC also will use the NATS data to evaluate the NTCP. Many of the NATS questions reflect CDC’s key outcome indicators for evaluating tobacco control programs. CDC proposes to conduct three annual cycles of the National Adult Tobacco Survey (NATS) to collect data necessary to evaluate the effectiveness of FDA’s initial regulatory actions. The NATS will be a stratified, random-digit dialed telephone survey of noninstitutionalized adults 18 years of age and older. To yield results that are representative nationally, information will be collected from 56,250 landline respondents. In addition, to include the growing population of households that exclusively use cell phones and would be missed in a survey relying only on land-lines, information will be collected from 18,750 cell phone respondents who do not have a landline. To obtain the target number of completed telephone interviews, approximately 166,000 respondents will be contacted for initial eligibility screening. Response is voluntary. Study results will have significant implications for the development and periodic adjustment of policies and programs aimed at preventing and reducing tobacco use in the United States. There are no costs to respondents except their time. tobacco product ingredients and design, establishing good manufacturing practices, instituting tobacco product labeling and health warnings; prohibiting marketing that is misleading to consumers and developing enforcement authorities to act quickly and effectively to remove violating products. In addition, the FSPTCA gives FDA the authority to assert jurisdiction over cigars and other currently unregulated tobacco products. Finally, FDA’s regulatory authority involves considering whether the marketing of tobacco products might encourage people who don’t use tobacco products to begin using them, encourage people who might otherwise quit to continue using tobacco, or encourage former users to relapse. In order to ensure that FDA is in compliance with the Tobacco Control Act’s mandate to protect the public health, annual data collection is needed at least initially to monitor the benefits and potential adverse consequences of FDA’s regulatory actions, as the regulatory framework is being established. The FDA must regularly monitor patterns of tobacco product usage—novel tobacco products as well as cigarettes—to identify changes in susceptibility and rates of tobacco use initiation, perceptions regarding tobacco use, and rates of tobacco use cessation. Rather than develop a completely new system to monitor measures critical to FDA, and thereby increasing burden to the population, FDA has partnered with CDC to leverage the existing NATS ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Type of respondent Form name Adults ages 18 or older .................... Screener for land-line users (pp 67– 78 of the NATS). Screener for cell phone users (pp 79–86 of the NATS). National Adult Tobacco Survey (pp 5–66 of the NATS)—landline. National Adult Tobacco Survey (pp 5–66 of the NATS)—cell phone. 125,000 1 2/60 4,167 41,000 1 1/60 683 56,250 1 20/60 18,750 18,750 1 20/60 6,250 ........................................................... ........................ ........................ ........................ 29,850 tkelley on DSK3SPTVN1PROD with NOTICES Total ........................................... Dated: January 6, 2012. Kimberly Lane, Reports Clearance Officer, Centers for Disease Control and Prevention. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2012–474 Filed 1–11–12; 8:45 am] National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings BILLING CODE 4163–18–P National Institutes of Health Pursuant to section 10(d) of the Federal Advisory Committee Act, as VerDate Mar<15>2010 16:26 Jan 11, 2012 Jkt 226001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, E:\FR\FM\12JAN1.SGM 12JAN1

Agencies

[Federal Register Volume 77, Number 8 (Thursday, January 12, 2012)]
[Notices]
[Pages 1938-1939]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-474]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-12-0828]

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 Lane, CDC Reports Clearance Officer, 1600
Clifton Road, MS D-74, 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

National Adult Tobacco Survey (NATS) (OMB No. 0920-0828, exp. 10/
31/2010)--Reinstatement with Changes--National Center for Chronic
Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease
Control and Prevention (CDC) and the Center for Tobacco Products (CTP),
Food and Drug Administration (FDA).

[[Page 1939]]

Background and Brief Description

Tobacco use remains the leading preventable cause of disease and
death in the United States, resulting in approximately 440,000 deaths
annually. Smokers die an average of 14 years earlier than non-smokers.
Moreover, cigarette smoking costs more than $193 billion; $97 billion
in lost productivity plus $96 billion in health care expenditures.
Although the prevalence of current smoking among adults in the United
States has declined significantly since 1964, in more recent years
(2004 to 2010) these declines have slowed or stalled with 1 in 5 adults
reporting current smoking. In addition, promotion of non-cigarette
tobacco products is leading to increased diversity of tobacco product
usage, including the use of multiple products.
With passage of the Family Smoking Prevention and Tobacco Control
Act (FSPTCA) in 2009, the Food and Drug Administration is legally
mandated to regulate tobacco products for the protection of public
health. Congress passed the FSPTCA to discourage tobacco use among
minors and young adults, to encourage cessation among adult smokers and
to reduce the public health burden of tobacco related disease in the
U.S. Under the Tobacco Control Act, FDA has been granted broad
authority to use the best available science to develop and implement
effective strategies to protect the public's health. FDA authority
includes setting and enforcing standards for tobacco product
ingredients and design, establishing good manufacturing practices,
instituting tobacco product labeling and health warnings; prohibiting
marketing that is misleading to consumers and developing enforcement
authorities to act quickly and effectively to remove violating
products. In addition, the FSPTCA gives FDA the authority to assert
jurisdiction over cigars and other currently unregulated tobacco
products. Finally, FDA's regulatory authority involves considering
whether the marketing of tobacco products might encourage people who
don't use tobacco products to begin using them, encourage people who
might otherwise quit to continue using tobacco, or encourage former
users to relapse.
In order to ensure that FDA is in compliance with the Tobacco
Control Act's mandate to protect the public health, annual data
collection is needed at least initially to monitor the benefits and
potential adverse consequences of FDA's regulatory actions, as the
regulatory framework is being established. The FDA must regularly
monitor patterns of tobacco product usage--novel tobacco products as
well as cigarettes--to identify changes in susceptibility and rates of
tobacco use initiation, perceptions regarding tobacco use, and rates of
tobacco use cessation. Rather than develop a completely new system to
monitor measures critical to FDA, and thereby increasing burden to the
population, FDA has partnered with CDC to leverage the existing NATS
system. While NATS has been re-designed to meet the critical data needs
of the FDA, many of the measures are relevant to CDC's National Tobacco
Control Program (NTCP), and CDC also will use the NATS data to evaluate
the NTCP. Many of the NATS questions reflect CDC's key outcome
indicators for evaluating tobacco control programs.
CDC proposes to conduct three annual cycles of the National Adult
Tobacco Survey (NATS) to collect data necessary to evaluate the
effectiveness of FDA's initial regulatory actions. The NATS will be a
stratified, random-digit dialed telephone survey of non-
institutionalized adults 18 years of age and older. To yield results
that are representative nationally, information will be collected from
56,250 landline respondents. In addition, to include the growing
population of households that exclusively use cell phones and would be
missed in a survey relying only on land-lines, information will be
collected from 18,750 cell phone respondents who do not have a
landline. To obtain the target number of completed telephone
interviews, approximately 166,000 respondents will be contacted for
initial eligibility screening.
Response is voluntary. Study results will have significant
implications for the development and periodic adjustment of policies
and programs aimed at preventing and reducing tobacco use in the United
States. There are no costs to respondents except their time.

Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
Adults ages 18 or older....... Screener for 125,000 1 2/60 4,167
land-line users
(pp 67-78 of
the NATS).
Screener for 41,000 1 1/60 683
cell phone
users (pp 79-86
of the NATS).
National Adult 56,250 1 20/60 18,750
Tobacco Survey
(pp 5-66 of the
NATS)--landline.
National Adult 18,750 1 20/60 6,250
Tobacco Survey
(pp 5-66 of the
NATS)--cell
phone.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 29,850
----------------------------------------------------------------------------------------------------------------

Dated: January 6, 2012.
Kimberly Lane,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2012-474 Filed 1-11-12; 8:45 am]
BILLING CODE 4163-18-P

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