[Federal Register Volume 62, Number 13 (Tuesday, January 21, 1997)]
[Notices]
[Pages 3044-3047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1340]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[INFO-97-01]


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 the CDC Reports 
Clearance Officer on (404) 639-7090.
    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 for other 
forms of information technology. Send comments to Wilma Johnson, CDC 
Reports Clearance Officer, 1600 Clifton Road, MS-D24, Atlanta, GA 
30333. Written comments should be received within 60 days of this 
notice.

Proposed Projects

    1. AIDS Prevention and Surveillance Project Reports, (0920-0208)--
Extension--CDC funds cooperative agreements for 65 HIV Prevention 
Projects (50 states, 6 cities, 7 territories, Washington, D.C., and 
Puerto Rico). The cooperative agreements support counseling, testing, 
referral, and partner notification programs conducted by official 
public health agencies of states, territories, and localities (project 
areas). HIV counseling and testing in STD clinics, Women's Health 
Centers, Drug Treatment Centers, and other health agencies has been 
described as a primary prevention strategy of the national HIV 
Prevention Program. These project areas have increased HIV counseling 
and testing activities to specifically reach more minorities and women 
of child bearing age.
    CDC is responsible for monitoring and evaluating HIV prevention 
activities conducted under the cooperative agreement. Counseling and 
testing programs are a major component of the HIV Prevention Program. 
Without data to measure the impact of counseling and testing programs, 
priorities cannot be assessed and redirected to prevent further spread 
of the virus in the general population. CDC needs information from all 
project areas on the number of at-risk persons tested and the number 
positive for HIV. The HIV Counseling and Testing Report Form provides a 
simple yet complete means to collect this information. We are 
requesting a three year extension for this study. The estimated cost to 
the respondents is $10,320 per year.

[[Page 3045]]



----------------------------------------------------------------------------------------------------------------
                                                                      No. of      Average burden/               
                   Respondents                        No. of        responses/     response (in    Total burden 
                                                    respondents     respondent         hrs.)         (in hrs.)  
----------------------------------------------------------------------------------------------------------------
Manual Form Project Areas.......................              21               4               2             168
Scan Form Project Areas.........................              44               4            0.25              44
                                                                                                 ---------------
    Total.......................................  ..............  ..............  ..............             212
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    2. Multi-Center Cohort Study to Assess the Risk and Consequences of 
Hepatitis C Virus Transmission from Mother to Infant (0920-0344)--
Extension--The purpose of the study is to determine the incidence of 
vertical hepatitis C virus (HCV) transmission, to assess risk factors 
for vertical HCV transmission, to assess the clinical course of disease 
among infants with HCV infection, and to assess diagnostic methods for 
detecting HCV infection in infants. Respondents for the study will be 
anti-HCV positive mothers.
    There is no cost to the respondents. They will be remunerated for 
travel costs; provided well-child visits and free vaccinations for 
infants enrolled in the study; and, provided anti-HCV testing to all 
family members free of charge. The total response burden for the study, 
over a 3 year period, is as follows:

----------------------------------------------------------------------------------------------------------------
                                                                      No. of       Avg. burden/                 
         Respondents               Form name          No. of        responses/     response (in    Total burden 
                                                    respondents     respondent         hrs.)         (in hrs.)  
----------------------------------------------------------------------------------------------------------------
Individual Mothers...........  Form A...........             300               1            0.25              75
Mothers......................  Form B...........            1200               1            0.25             300
Mothers......................  Form C...........             300               1            0.10              30
Mothers......................  Form D...........             300               1            0.25              75
Family members...............  Form E...........             700               1            0.25             175
Mothers......................  Form F...........             300               1            0.25              75
Mothers......................  Form G...........             300               8            0.10             240
                                                                                                 ---------------
    Total....................  .................  ..............  ..............  ..............          * 970 
----------------------------------------------------------------------------------------------------------------
* The annualized response burden is estimated to be 970 hours/3 years=323 hours.                                
(Target enrollment in the study is 300; the target population will be drawn from those who complete Form B.     
  Family members will complete Form E.)                                                                         

    3. Continuing Medical Education (CME) Activity Registration Form--
(0923-0013)--Extension--The Agency for Toxic Substances and Disease 
Registry (ATSDR) is mandated pursuant to the 1980 Comprehensive 
Environmental Response Compensation and Liability Act (CERCLA) and its 
1986 Amendments, The Superfund Amendments and Reauthorization Act 
(SARA), to prevent or mitigate adverse human health effects and 
diminished quality of life resulting from the exposure to hazardous 
substances into the environment. As stated in CERCLA, the Administrator 
of ATSDR is charged to ``assemble, develop as necessary, and distribute 
to the states, and upon request to medical colleges, physicians, and 
other health professionals, appropriate educational materials 
(including short courses) on this topic''.
    The development and use of activity registration forms for 
documenting participation in these activities at these meetings is an 
integral part of this process. This attendance documentation process is 
required by the Accreditation Council for Continuing Medical Education 
(ACCME), the body that authorizes agencies and institutions to award 
nationally recognized continuing medical education (CME) credit. As a 
condition of relicensure, physicians in 40 states are required to 
participate in CME courses. Individual physicians in these states are 
required to submit the number of hours of CME credit to state boards of 
professional registration at the time of relicensure. Failure by the 
physician to provide this information in a timely fashion will result 
in suspension of professional licensure.
    This request is for a 3-year extension of the current OMB approval 
of uniform CME activity registration forms--one machine entry form and 
the other manually entered--to serve as the initial step in the 
development of an attendance documentation system. Other than their 
time, there will be no cost to the respondents.

----------------------------------------------------------------------------------------------------------------
                                                                      No. of      Average burden/               
                   Respondents                        No. of        responses/     response (in    Total burden 
                                                    respondents     respondent         hrs.)         (in hrs.)  
----------------------------------------------------------------------------------------------------------------
Manual Entry Registration Form..................           2,000               1           0.066             132
Scantron Registration form......................           3,000               1           0.083             250
                                                                                                 ---------------
    Total.......................................  ..............  ..............  ..............             382
----------------------------------------------------------------------------------------------------------------

    4. National Surveillance System for Hospital Health Care workers 
(NASH)--New--CDC has developed surveillance system that focuses on 
surveillance of exposures and infections among hospital-based health 
care workers (HCWs). This system, modeled after the National Nosocomial 
Infections Surveillance (NNIS) system for patient infections, includes 
standardized methodology for various occupational health issues (OMB 
0920-0012). The Hospital Infections Program, National Center for 
Infectious Diseases (NCID) has developed this system in

[[Page 3046]]

collaboration with the Hepatitis Branch, Division of Viral and 
Rickettsial Diseases, NCID; the Division of Tuberculosis (TB) 
Elimination, National Center for HIV, STD, and TB Prevention; the 
National Immunization Program (NIP), and the National Institute for 
Occupational Safety and Health (NIOSH).
    The NASH system consists of modules for collection of data about 
various occupational issues. Baseline information about each HCW such 
as demographics, immune-status for vaccine-preventable diseases, and TB 
status is collected when the HCW is enrolled in the system. Results of 
routine tuberculin skin test (TST) are collected and entered in the 
system every time a TST is placed and read. In the event that an HCW is 
exposed to blood/bloodborne pathogen, to a vaccine-preventable disease, 
or to a TB infectious patient/HCW, epidemiologic data will be collected 
about the exposure. For HCWs exposed to a bloodborne pathogen (i.e. 
HIV, HCV, or HBC), follow-up data will be collected during the follow-
up visits. Once a year, the hospitals will perform a survey to assess 
the level of underreporting of needlesticks (HCW survey) and will 
complete a hospital survey to provide denominator data. Data will be 
sent entered into the software and diskettes will be sent to CDC. No 
identifiers of the HCW will be sent to CDC. This system is protected by 
the Assurance of Confidentiality (308d).
    Data collected in this surveillance system will assist hospitals, 
HCWs, HCW organizations, and public health agencies. This system will 
allow CDC to monitor national trends, to identify newly emerging 
hazards for HCWs, to assess the risk of occupational infection, and to 
evaluate preventive measures, including engineering controls, work 
practices, protective equipment, and postexposure prophylaxis to 
prevent occupationally acquired infections. Hospitals who volunteer to 
participate in this system will benefit by receiving technical support 
and standardized methodologies, including software, for conducting 
surveillance activities on occupational health.
    This system has been developed and piloted in large teaching 
hospitals. Prior to implementation in a nationwide network of 
hospitals, an expansion of this pilot project to include more medium/
small size hospitals is essential for further refinement of protocols 
and software. The first pilot project ran from October 1994 to 
September 1996 (RFP-200-94-0834(p)) and included four hospitals; the 
second pilot started in October 1996 (RFP-200-96-0524(P)) and includes 
five hospitals. Fifteen hospitals are expected to participate in this 
proposed project, including the five currently participating. Once the 
expanded pilot project is completed, the system will be made available 
to all short-term care hospitals in the United States who wish to 
voluntarily participate in this project. The total estimated maximum 
cost to respondents is $201,840 ($15 an hour for hospital personnel who 
will collect/input the data).

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                                      No. of       Avg. burden/                 
                   Respondents                        No. of        responses/     response (in    Total burden 
                                                    respondents     respondents        hrs.)         (in hrs.)  
----------------------------------------------------------------------------------------------------------------
Baseline Information (form).....................          22,500               1          0.3333           7,500
TST Result Form.................................          22,500               1          0.1666           3,750
Exposure Form...................................           1,500               1           0.416             625
Follow-up Form..................................             750               1            0.25             188
Exposure to vaccine-prv. dis Summary Form.......             120               1           0.333              40
HCW Form........................................             240               1           0.333              80
Exposure to TB Form.............................              45               1            0.50              23
HCW Survey......................................           7,500               1           0.166           1,250
                                                                                                 ---------------
  Total.........................................  ..............  ..............  ..............         13,456 
----------------------------------------------------------------------------------------------------------------
*The same 15 hospitals will be completing the 8 separate forms listed above. The number of respondents includes 
  x number of employees time each of 15 hospitals.                                                              

    5. Information Collection Procedures for Requesting Public Health 
Assessments--(0923-0002)--Extension--The Agency for Toxic Substances 
and Disease Registry is announcing the request for a 3-year extension 
of the OMB approval for the Information Collection Procedures for 
Requesting Public Health Assessments. ATSDR is authorized to accept and 
respond to petitions from the public that request public health 
assessments of sites where there is a threat of exposure to hazardous 
substances (42 USC 9604(i)(6)(B)). The Agency conducts public health 
assessments of releases or facilities for which individuals provide 
information that people have been exposed to a hazardous substance, and 
for which the source of such exposure is a release, as defined under 
CERCLA. The general administrative procedures for conducting public 
health assessments, including the information that must be submitted 
with each request, is described at 42 CFR 90.3, 90.4, and 90.5. 
Procedures for responding to petitions, decision criteria, and 
methodology for determining priorities may be found at 57 FR 37382-89.
    ATSDR anticipates approximately 36 requests will be received each 
year. This estimate is based on the number of requests received since 
the enabling legislation was enacted and the expressions of interest 
(via telephone, letter, etc.) from members of the public, attorneys, 
and industry representatives. There is no cost to the respondents other 
than their time.

----------------------------------------------------------------------------------------------------------------
                                                                      No. of        Avg. burden                 
                   Respondent                         No. of         responses     response (in    Total burden 
                                                    respondents     respondents        hrs.)         (in hrs.)  
----------------------------------------------------------------------------------------------------------------
General Public..................................               3               1             .50              18
-------------------------------------------------                                                               

[[Page 3047]]

                                                                                                                
    Total.......................................  ..............  ..............  ..............              18
----------------------------------------------------------------------------------------------------------------

    Dated: January 14, 1997.
Wilma G. Johnson,
Acting Associate Director for Policy Planning and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 97-1340 Filed 1-17-97; 8:45 am]
BILLING CODE 4163-18-P