Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices 1147

recommended a comprehensive public

review of the scientific and ethical

issues raised by such studies. In

response, NIH convened a national Gene

Therapy Policy Conference on Prenatal

Gene Transfer: Scientific, Medical, and

Ethical Issues (January 7–8, 1999) to

further explore these issues.

The findings and conclusions of the

Conference indicated that, at present,

there is insufficient preclinical data to

support the initiation of clinical trials

involving in utero gene transfer clinical

research. A substantial number of

critical scientific, safety, ethical, legal,

and social issues must be addressed

before clinical trials proceed in this

arena including: (1) Efficiency of gene

transfer to target cells; (2) specificity of

delivery to target cells; (3) level,

duration, and regulation of gene

expression; (4) appropriate disease

candidates; (5) fetal immune response to

transgene products and/or vectors; (6)

emergence of fetal immune tolerance;

(7) effects of gene transfer on pre- and

post-natal development; (8) possibility

of generation and activation of

transmissible vector or virus; (9)

possibility of initiating oncogenic or

degenerative processes; (10) limitations

related to the accuracy of disease

diagnosis; (11) implications of

diagnostic limitations on the design and

conduct of clinical trials; (12) elements

of optimal clinical trial design and

analysis; (13) potential risk to the fetus

and acceptable level of risk to the fetus

in human experimentation; (14)

potential risk to the pregnant woman;

(15) detection and assessment of

inadvertent germ-line transmission; (16)

ethical issues specific to the fetus; (17)

ethical issues specific to the pregnant

woman; (18) patient recruitment/

enrollment processes; (19) informed

consent issues; (20) societal issues; and

(21) legal issues. (See http://

www4.od.nih.gov/oba/gtpcreport.pdf

for further information.)

In March 1999, RAC discussed the

findings and conclusions of the

conference and developed the following

consensus statement: ‘‘The RAC

continues to explore the issues raised by

the potential of in utero gene transfer

research. However, at present, the

members unanimously agree that it is

premature to undertake any human in

utero gene transfer experiment.’’ After

providing an opportunity for public

comments (64 FR 43884), the RAC

unanimously recommended that this

consensus statement be adopted as

policy and incorporated into the NIH

Guidelines (Appendix M). The NIH is

implementing this recommendation

through this notice of action.

Action Amending the NIH Guidelines

Appendix M. Points to Consider in the

Design and Submission of Protocols for

the Transfer of Recombinant DNA

Molecules into One or More Human

Research Participants (Points to

Consider)

Appendix M is amended by adding

the following paragraph after the third

paragraph:

‘‘The RAC continues to explore the

issues raised by the potential of in utero

gene transfer clinical research. However,

the RAC concludes that, at present, it is

premature to undertake any in utero

gene transfer clinical trial. Significant

additional preclinical and clinical

studies addressing vector transduction

efficacy, biodistribution, and toxicity

are required before a human in utero

gene transfer protocol can proceed. In

addition, a more thorough

understanding of the development of

human organ systems, such as the

immune and nervous systems, is needed

to better define the potential efficacy

and risks of human in utero gene

transfer. Prerequisites for considering

any specific human in utero gene

transfer procedure include an

understanding of the pathophysiology of

the candidate disease and a

demonstrable advantage to the in utero

approach. Once the above criteria are

met, the RAC would be willing to

consider well rationalized human in

utero gene transfer clinical trials.’’

OMB’s ‘‘Mandatory Information

Requirements for Federal Assistance

Program Announcements’’ (45 FR

39592) requires a statement concerning

the official government programs

contained in the Catalog of Federal

Domestic Assistance. Normally, NIH

lists in its announcements the number

and title of affected individual programs

for the guidance of the public. Because

the guidance in this notice covers

virtually every NIH and Federal

research program in which recombinant

DNA techniques could be used, it has

been determined not to be cost effective

or in the public interest to attempt to list

these programs. In addition, NIH could

not be certain that every Federal

program would be included as many

Federal agencies, as well as private

organizations, both national and

international, have elected to follow the

NIH Guidelines. In lieu of the

individual program listing, NIH invites

readers to direct questions to the

information address above about

whether individual programs listed in

the Catalog of Federal Domestic

Assistance are affected.

Dated: December 28, 2000.

Ruth L. Kirschstein,

Acting Director, National Institutes of Health.

[FR Doc. 01–337 Filed 1–4–01; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with Section

3506(c)(2)(A) of the Paperwork

Reduction Act of 1995 concerning

opportunity for public comment on

proposed collections of information, the

Substance Abuse and Mental Health

Services Administration will publish

periodic summaries of proposed

projects. To request more information

on the proposed projects or to obtain a

copy of the information collection

plans, call the SAMHSA Reports

Clearance Officer on (301) 443–7978.

Comments are invited on: (a) Whether

the proposed collections of information

are 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 or

other forms of information technology.

Proposed Project: Pilot Testing of

Outcome Measures in Programs

Providing Services to Persons Who are

Homeless and Have Serious Mental

Illnesses—New—SAMHSA’s Center for

Mental Health Services (CMHS)

provides funds to states and territories

to provide services to individuals who

are homeless and have serious mental

illnesses. These services enable persons

who are homeless and have serious

mental illnesses to be placed in

appropriate housing situations and

linked to mental health services. To

comply with requests for client outcome

data, State and local providers have

sought measures which could help them

more effectively monitor and manage

their programs as well as demonstrate

program effectiveness.

Interest in performance measurement

and evaluation of policies, programs

and individual services has increased

1148 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices

dramatically with the passage of the

Government Performance and Results

Act (GPRA) in 1993. GPRA focuses new

attention on the quality of outcome

measures used to collect information

about publicly funded programs.

Programs that provide services to

persons who are homeless and have

serious mental illnesses are facing

greater need to document their

effectiveness. These outcome data will

ultimately be used in responding to

Congressional and HHS oversight,

GPRA requirements, and the requests of

other governmental levels, managed

care companies, and private funding

sources.

The project will test the

appropriateness and feasibility of

selected indicators to measure the

outcome of services to persons who are

homeless and have serious mental

illnesses. Outcome measures to be

evaluated include housing status,

sobriety or drug-free status, mental

health treatment status, enrollment in

an educational program, and

employment.

In addition, the project will evaluate

process measures pertaining to

outreach, service delivery and linkage

stages of intervention. These process

indicators include the type of contact

(i.e., referrals, walk-ins, fixed outreach,

and mobile outreach); whether the

person contacted agreed to services,

reasons for any non-enrollment, and

referral to, and provision of, specific

services.

The project will test these outcome

and process measures in a total of

approximately six provider agencies in

each of five participating States. The

findings of the pilot test will serve as

the basis for recommendations for a

voluntary national implementation of

data collection in similar programs,

nationwide. It will also test the

feasibility of compiling such data in a

central data collection point.

Local providers will report

information on services provided to

individuals served. Providers will report

aggregate information from their records

for all new clients during a one-month

period. Information will be reported on

the initial client contact, on services

clients receive over the next six months

and on client outcomes at the end of six

months. In addition, half of the provider

agencies will report client followup

information at a period 60 days after the

conclusion of the six-month period. It is

anticipated that this information will be

collated from existing provider records.

Data will be submitted to the central

data point in aggregate form, not by

individual client. Projected response

burden for the project is summarized in

the table below.

Estimated

number of

respondents

Estimated

number of

responses

per

respondent

Average

burden

hours per

response

Estimated

total annual

burden

hours

requested

Initial and six-month aggregate report ............................................................................. 30 1 10 300

Follow-up aggregate report ............................................................................................. 15 1 10 150

Total .......................................................................................................................... 30 .................... .................... 450

Send comments to Nancy Pearce,

SAMHSA Reports Clearance Officer,

Room 16–105, Parklawn Building, 5600

Fishers Lane, Rockville, MD 20857.

Written comments should be received

within 60 days of this notice.

Dated: December 29, 2000.

Richard Kopanda,

Executive Officer, SAMHSA.

[FR Doc. 01–309 Filed 1–4–01; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Current List of Laboratories Which

Meet Minimum Standards To Engage in

Urine Drug Testing for Federal

Agencies

AGENCY: Substance Abuse and Mental

Health Services Administration, HHS.

ACTION: Notice.

SUMMARY: The Department of Health and

Human Services notifies Federal

agencies of the laboratories currently

certified to meet standards of Subpart C

of Mandatory Guidelines for Federal

Workplace Drug Testing Programs (59

FR 29916, 29925). A similar notice

listing all currently certified laboratories

will be published during the first week

of each month, and updated to include

laboratories which subsequently apply

for and complete the certification

process. If any listed laboratory’s

certification is totally suspended or

revoked, the laboratory will be omitted

from updated lists until such time as it

is restored to full certification under the

Guidelines.

If any laboratory has withdrawn from

the National Laboratory Certification

Program during the past month, it will

be listed at the end, and will be omitted

from the monthly listing thereafter.

This Notice is also available on the

internet at the following website: http:/

/www.health.org/workplace

FOR FURTHER INFORMATION CONTACT: Mrs.

Giselle Hersh or Dr. Walter Vogl,

Division of Workplace Programs, 5600

Fishers Lane, Rockwall 2 Building,

Room 815, Rockville, Maryland 20857;

Tel.: (301) 443–6014, Fax: (301) 443–

3031.

Special Note: Please use the above

address for all surface mail and

correspondence. For all overnight mail

service use the following address:

Division of Workplace Programs, 5515

Security Lane, Room 815, Rockville,

Maryland 20852.

SUPPLEMENTARY INFORMATION:

Mandatory Guidelines for Federal

Workplace Drug Testing were developed

in accordance with Executive Order

12564 and section 503 of Pub. L. 100–

71. Subpart C of the Guidelines,

‘‘Certification of Laboratories Engaged

in Urine Drug Testing for Federal

Agencies,’’ sets strict standards which

laboratories must meet in order to

conduct urine drug testing for Federal

agencies. To become certified an

applicant laboratory must undergo three

rounds of performance testing plus an

on-site inspection. To maintain that

certification a laboratory must

participate in a quarterly performance

testing program plus periodic, on-site

inspections.

Laboratories which claim to be in the

applicant stage of certification are not to

be considered as meeting the minimum

requirements expressed in the HHS

Guidelines. A laboratory must have its

letter of certification from SAMHSA,

HHS (formerly: HHS/NIDA) which

attests that it has met minimum

standards.

In accordance with Subpart C of the

Guidelines, the following laboratories