[Federal Register Volume 63, Number 195 (Thursday, October 8, 1998)]
[Notices]
[Pages 54140-54141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26987]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30DAY-01-99]
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 Project
1. Statement in Support of Application for Waiver of
Inadmissibility--(0920-0006)--Extension--National Center for Infectious
Disease Control and Prevention (NCID)--Section 212(a)(1) of the
Immigration and Nationality Act states that aliens with specific
health-related conditions are ineligible to receive visas and
ineligible for admission into the United States. The Attorney General
may waive application of this inadmissibility on health-related grounds
if an application for waiver is filed and approved by the consular
office considering the application for a visa. The Division of
Quarantine, NCID uses this application primarily to collect information
to establish and maintain records of waiver applicants in order to
notify the Immigration and Naturalization Service (INS) when terms,
conditions, and controls imposed by waiver are not met. We are
requesting the extension of this data collection for three years. The
total burden hours are 33.
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Number of Avg. burden/
Respondents Number of responses/ responses (in
respondents respondents hrs.)
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Businesses or Organizations.................................. 2001 1 .165
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2. Gonococcal Isolate Surveillance Project (GISP) (0920-0307)--
Extension--The Division of STD Prevention, National Center for HIV, STD
and TB Prevention (NCHSTP) is requesting a 3-year extension of OMB
clearance to continue the Gonococcal Isolate Surveillance Project
(GISP). The objectives of GISP are: (1) to monitor trends in
antimicrobial susceptibility of strains of Neisseria gonorrhoeae in the
United States and (2) to characterize resistant isolates. GISP provides
critical surveillance for antimicrobial resistance, allowing for
informed
[[Page 54141]]
treatment recommendations. GISP was begun in 1986 as a voluntary
surveillance project and now involves 5 regional laboratories and 26
publicly funded sexually transmitted disease clinics around the
country. The STD clinics submit up to 25 gonococcal isolates per month
to the regional laboratories, which measure susceptibility to a panel
of antibiotics. Limited demographic and clinical information
corresponding to the isolates are submitted directly by the clinics to
CDC.
During 1986-1997, GISP has demonstrated the ability to effectively
achieve its objectives. The recent emergence of resistance to
fluoroquinolones, commonly used therapies for gonorrhea, has been
identified through GISP and makes ongoing surveillance critical. Data
gathered through GISP are used to alert the public health community to
changes in antimicrobial resistance in N. gonorrhoeae which may impact
treatment choices, and to guide recommendations made in CDC's STD
Treatment Guidelines, which are published every several years. The
total burden hours are 6196.
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Number of
Respondent Number of responses/ Avg. burden
respondents respondents (in hrs.)
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Laboratory...................................................... 5 1056 1
Clinic.......................................................... 26 204 0.166
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3. Annual Submission of the Quantity of Nicotine Contained in
Smokeless Tobacco Products Manufactured, Imported, or Packaged in the
United States--New--Oral use of smokeless tobacco represents a
significant health risk which can cause cancer and a number of
noncancerous oral conditions, and can lead to nicotine addiction and
dependence. The Centers for Disease Control and Prevention's (CDC)
Office on Smoking and Health (OSH) has been delegated the authority for
implementing major components of the Department of Health and Human
Services' (HHS) tobacco and health program, including collection of
tobacco ingredients information. HHS's overall goal is to reduce death
and disability resulting from cigarette smoking and other forms of
tobacco use through programs of information, education and research.
The Comprehensive Smokeless Tobacco Health Education Act of 1986
(15 U.S.C. 4401 et seq., Pub. L. 99-252) requires that each person who
manufactures, packages, or imports smokeless tobacco provide the
Secretary of HHS annually with a report on the quantity of nicotine
contained in smokeless tobacco products. This notice implements this
nicotine reporting requirement. CDC is requesting OMB clearance to
collect this information for three years. A standard methodology for
measurement of quantity of nicotine in smokeless tobacco has been
developed. The methodology (``Protocol for Analysis of Nicotine, Total
Moisture, and pH in Smokeless Tobacco Products'') is intended to
provide standardized measurement of nicotine, total moisture, and pH in
smokeless tobacco products.
Background
In 1989, the smokeless industry submitted a business review letter
to the Department of Justice (DOJ), in accordance with 28 C.F.R.
Section 50.6. This letter requested approval of a collaborative
industry effort to determine standard nicotine reporting. In January
1993, DOJ extended permission to the smokeless industry to begin the
development of uniform methods for analyzing smokeless tobacco products
for nicotine or moisture content. The first meeting of the work group,
which represented the ten major domestic manufacturers of smokeless
tobacco, was convened on July 7, 1993. After a series of meetings of
the joint industry work group, a standard methodology was approved by
the work group and submitted to OSH for approval. The protocol was
revised by OSH based on individual comments received from peer
reviewers and the Division of Environmental Health Laboratory Sciences,
National Center for Environmental Health, CDC. The total annual burden
hours are 18766.*
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Number of Average burden/
Respondents Number of responses/ response (in
respondents respondent hrs.)
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Tobacco manufacturers........................................ 11 1 1,706
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* Please note that these figures are based on the average reporting time and cost estimations for six major
smokeless tobacco manufacturers as reported by Patton Boggs, LLP.
Charles W. Gollmar,
Acting Associate Director for Policy, Planning and Evaluation, Centers
for Disease Control and Prevention (CDC).
[FR Doc. 98-26987 Filed 10-7-98; 8:45 am]
BILLING CODE 4163-18-P
