Federal Register / Vol. 62, No. 145 / Tuesday, July 29, 1997 / Notices 40535

Wilma G. Johnson,

Acting Associate Director for Policy Planning

And Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–19892 Filed 7–28–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[30DAY–17–97]

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

Office on (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. National Surveillance System for

Hospital Health Care workers (NASH)—

New—CDC has developed a

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

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 under reporting 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

annual burden hours are 14,554.

Respondents Number of

respondents

Number of

responses/

respondents

Average burden/response

(in hours)

Baseline Information Form ..................................................................................................................... 15 1,500 0.3333

TST—Result Form ................................................................................................................................. 15 1,500 0.1666

TST—Evaluation Form ........................................................................................................................... 15 13 0.1666

Exposure to Blood Form ........................................................................................................................ 15 100 0.4166

Exposure to Blood Follow-up Form ....................................................................................................... 15 50 0.25

Exposure to vaccine-prv. dis—Summary Form ..................................................................................... 15 8 0.3333

Exposure to vaccine-prv. dis—HCW Form ............................................................................................ 15 16 0.3333

Exposure to TB Form ............................................................................................................................. 15 3 0.50

Exposure to Non-Infectious Injury Form ................................................................................................ 15 133 0.3333

Exposures to Blood During Surgery Form ............................................................................................. 15 80 0.1666

Exposures to Blood During OB Deliveries Form ................................................................................... 15 80 0.1666

HCW Survey ........................................................................................................................................... 15 500 0.1666

*The same 15 hospitals will be completing the 12 separate forms listed above. The number of respondents includes x number of employees

times each of 15 hospitals.
40536 Federal Register / Vol. 62, No. 145 / Tuesday, July 29, 1997 / Notices

Wilma G. Johnson,

Acting Associate Director for Policy Planning

And Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–19893 Filed 7–28–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 93N–0453]

Guidance for Screening and Testing of

Donors of Human Tissue Intended for

Transplantation; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance document

entitled ‘‘Guidance for Screening and

Testing of Donors of Human Tissue

Intended for Transplantation.’’ The

purpose of the guidance document is to

assist facilities involved in recovery,

infectious disease testing, screening,

processing, storing, or distributing

human tissue intended for

transplantation. The guidance document

provides information on procedures and

practices for donor screening and

testing. FDA prepared the guidance

document after receiving public input.

The topics included in the guidance

document were contained in a draft

document ‘‘Screening and Testing of

Donors of Human Tissue Intended for

Transplantation’’ made available for

discussion at a public workshop on

human tissue held on June 20 and 21,

1995.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of the ‘‘Guidance for

Screening and Testing of Donors of

Human Tissue Intended for

Transplantation’’ to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

that office in processing your requests.

The document may also be obtained by

mail by calling the CBER Voice

Information System at 1–800–835–4709

or 301–827–1800, or by fax by calling

the FAX Information System at 1–888–

CBER–FAX or 301–827–3844.

Persons with access to the Internet

may obtain the document using File

Transfer Protocol (FTP), the World Wide

Web (WWW), or bounce–back e–mail.

For FTP access, connect to CBER at

‘‘ftp://ftp.fda.gov/cber/’’. For WWW

access, connect to CBER at ‘‘http://

www.fda.gov/cber/publications.htm’’.

To receive the document by bounce–

back e–mail, send a message to

‘‘tissue2@a1.cber.fda.gov’’.

Submit written comments on the

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Two copies of any comments are

to be submitted, except individuals may

submit one copy. Requests and

comments are to be identified with the

docket number found in brackets in the

heading of this document. The guidance

document and received comments are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

FOR FURTHER INFORMATION CONTACT:

Paula S. McKeever, Center for Biologics

Evaluation and Research (HFM–630),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–594–3074.

SUPPLEMENTARY INFORMATION: In the

Federal Register of December 14, 1993

(58 FR 65514), FDA published an

interim rule on human tissue intended

for transplantation to reduce the risk of

transmission of human

immunodeficiency virus (HIV) and

hepatitis through human tissue

intended for transplantation. The

interim rule was issued under the

authority of sections 215, 311, 361, and

368 of the Public Health Service Act (42

U.S.C. 216, 243, 264, 271) because of an

immediate need to protect the public

health from the transmission of

communicable diseases through the

transplantation of human tissue. The

interim rule established requirements

for the testing of donors of human tissue

for HIV Type 1 virus, HIV Type 2 virus,

hepatitis B virus, and hepatitis C virus.

The interim rule also required that

donors be screened for medical history,

including behaviors that carry an

increased risk of exposure to these

viruses (behavioral and high risk

information) and for signs and

symptoms of infection with these

viruses.

In the Federal Register of June 20,

1995 (60 FR 32128), FDA announced the

availability for public comment of a

draft document entitled ‘‘Screening and

Testing of Donors of Human Tissue

Intended for Transplantation.’’ The

availability of the draft document

coincided with the workshop on Human

Tissue for Transplantation and Human

Reproductive Tissue: Scientific and

Regulatory Issues and Perspectives

which was held on June 20 and 21,

1995. Comments received on this draft

document and the issues discussed at

the workshop were considered in the

development of the guidance document

being announced in this notice.

This guidance document provides

general information on the following

procedures: (1) Determination of donor

suitability, (2) evaluation of screening

test performance, (3) application of a

plasma dilution algorithm to determine

the acceptability of the blood specimen

used for testing, (4) screening for

behavioral and high risk information,

and (5) evaluation of clinical and

physical evidence of infection with HIV

or hepatitis.

As technical standards change over

time due to an increased understanding

of infectious diseases and improved

technology for testing, FDA may issue

future guidance to help ensure that the

regulatory process reflects the current

level of knowledge. The

recommendations in this guidance

document should be considered in

addition to voluntary standards

developed and used by human tissue

organizations.

This document is not being issued

under the authority of 21 CFR 10.90(b)

because FDA is in the process of

revising this section. As with other

guidance documents, FDA does not

intend this document to be all–

inclusive. This document does not bind

the agency and does not create or confer

any rights, privileges, or benefits for or

on any person. Tissue facilities may

follow the guidance document or may

choose to use alternative procedures not

provided in the guidance document. If

a tissue facility chooses to use

alternative procedures, the facility may

wish to discuss the matter further with

the agency to prevent expenditure of

resources on activities that may be

unacceptable to FDA.

Interested persons may, at any time,

submit written comments to the Dockets

Management Branch (address above)

regarding this guidance document. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. Continued comment by the

human tissue industry is encouraged,

and comments will be continuously

accepted by the Dockets Management

Branch.

FDA periodically will review written

comments on the guidance document to