[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.)
----------------------------------------------------------------------------------------------------------------
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.)
----------------------------------------------------------------------------------------------------------------
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.)
----------------------------------------------------------------------------------------------------------------
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