Proposed Data Collections Submitted for Public Comment and Recommendations

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.

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No. of Average burden/

Respondents No. of responses/ response (in Total burden

respondents respondent hrs.) (in hrs.)

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Manual Form Project Areas....................... 21 4 2 168

Scan Form Project Areas......................... 44 4 0.25 44

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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:

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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

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Total.................... ................. .............. .............. .............. * 970

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* 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.

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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

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Total....................................... .............. .............. .............. 382

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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).

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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

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Total......................................... .............. .............. .............. 13,456

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*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.

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No. of Avg. burden

Respondent No. of responses response (in Total burden

respondents respondents hrs.) (in hrs.)

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

General Public.................................. 3 1 .50 18

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Total....................................... .............. .............. .............. 18

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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