Federal Register / Vol. 62, No. 20 / Thursday, January 30, 1997 / Notices 4547

delayed several days after the test is

offered and information given to the

patient. This would give people

considering testing the opportunity to

absorb information about the test,

contemplate the implications of testing,

and discuss testing with others.

Rare Genetic Diseases

Physicians who encounter patients

with symptoms and signs of rare genetic

diseases should have access to the best

available information about rare genetic

diseases. This will enable them to

include such diseases in their

differential diagnosis, to know where to

turn for assistance in clinical and

laboratory diagnosis, and to find

laboratories that test for rare diseases.

The quality of laboratories providing

tests for rare diseases must be assured,

and a comprehensive system to collect

data on rare diseases must be

established. Although these are issues

that relate primarily to the diagnosis of

patients with symptoms and signs, they

have major implications for predictive

testing in asymptomatic relatives who

may be at risk of disease or who are

carriers of alleles for the disease and

whose future children may be at risk.

The Task Force is aware of a number

of efforts to address one or more of these

issues, including the availability of

disease-based databases on research

projects by the NIH Office of Rare

Diseases (ORD), on information for

consumers and providers by the

National Organization of Rare Disorders,

the Alliance of Genetic Support Groups

and its member organizations, and by

the American Academy of Pediatrics,

and on clinical laboratories providing

tests through the Helix National

Directory (available to providers only).

In addition, the Society for Inherited

Metabolic Disorders is compiling

information for providers on diagnostic

evaluations of rare disorders, and the

ACMG is developing databases on tests

that should be used for diagnosis of

specific disorders.

The Task Force recommends that NIH

give ORD a mandate to coordinate these

public and private efforts to improve

awareness of rare genetic diseases. Such

coordination is important to avoid

unnecessary duplication, to use

expertise most efficiently and to address

the concerns of the various groups. ORD

could serve as a gateway for provider

and public inquiries about these

disorders.

In cooperation with other

organizations, and on a regular basis,

ORD should identify laboratories worldwide that perform tests for rare genetic

diseases, the methodology employed,

and whether the tests they provide are

in the investigational stage, or are being

used for clinical diagnosis and decision

making. Laboratories should notify ORD

about impending cessation of their

testing so that provisions for a transition

to other laboratories can be made.

ORD should also be responsible for

assuring that tests for rare genetic

diseases, which have been demonstrated

to be safe and effective, continue to be

available if and when their developers

leave the field, and no other laboratory

is prepared to offer the test, and/or the

methodology is too complex to be

readily adopted by other laboratories.

The Task Force urges that additional

funds be appropriated for ORD to

undertake this expanded role.

In accordance with current law, the

Task Force is of the opinion that any

laboratory performing any genetic test

on which clinical diagnostic and/or

management decisions are made should

be certified under CLIA. If specimens

must be sent to a non-CLIA licensed

research facility, the referring physician

must be made aware of the investigative

nature of the test.

The Task Force recognizes that the

current CLIA certification process may

place a heavy burden on some

laboratories doing small numbers of

diagnostic tests for rare diseases. Several

laboratories currently performing these

tests are primarily engaged in research,

with the tests stemming from their

research efforts. Without

accommodation, some tests may cease

to be available. Therefore, the Task

Force recommends that the proposed

Genetics Advisory Committee to CLIAC

explore means to simplify compliance

with CLIA without sacrificing quality,

just as accommodations have been made

for rare genetic disease testing within

the New York State Department of

Health laboratory permit process.

Recognizing current deficiencies under

CLIA in the assessment of genetic tests

(discussed above), the Task Force also

encourages CAP/ACMG to make its

clinical accreditation programs available

to low-volume laboratories that are

unaffiliated with a hospital, and modify

its procedures to accommodate such

laboratories.

Directories of laboratories providing

tests for rare diseases should indicate

whether or not the laboratory is CLIAcertified and whether it has satisfied

other quality assessments, such as the

CAP/ACMG program.

The recommendation made earlier,

calling on the CDC to expand its data

monitoring capabilities, is intended to

include rare diseases. Collecting data on

rare diseases will require coordinating

data from multiple sources. It is

particularly needed to validate tests,

describe the natural history of rare

diseases and determine the safety and

effectiveness of interventions to prevent

disease or ameliorate its severity.

(Catalogue of Federal Domestic Assistance

Program No. 93.172, Human Genome

Research.)

Elke Jordan,

Executive Secretary, National Advisory

Council for Human Genome Research.

[FR Doc. 97–2286 Filed 1–29–97; 8:45 am]

BILLING CODE 4140–01–P

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 for opportunity

for public comment on proposed data

collection projects, 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 data collection plans and

instruments, contact the SAMHSA

Reports Clearance Officer at (301) 443–

8005.

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

or other forms of information

technology.

Proposed Project

Mandatory Guidelines for Federal

Workplace Drug Testing Program and

Associated Forms—Extension of OMB

approval will be requested for the

Federal Custody and Control Form for

Federal agency and federally regulated

drug testing programs which must

comply with the HHS Mandatory

Guidelines, for the application and

inspection forms for the National

Laboratory Certification Program

(NLCP), and for the reporting and

recordkeeping language in the

Guidelines. The Federal Custody and

Control Form is used by all Federal

agencies and employers regulated by the
4548 Federal Register / Vol. 62, No. 20 / Thursday, January 30, 1997 / Notices

Department of Transportation to

document the collection and chain of

custody of urine specimens at the

collection site, for laboratories to report

results, and for Medical Review Officers

to make a determination. No changes are

proposed to this form. Prior to an

inspection, a laboratory is required to

submit specific information regarding

its laboratory procedures to allow

inspectors to become familiar with a

laboratory’s procedures before arriving

at the laboratory. The annual total

burden estimates for the custody and

control form, the NLCP application, the

NLCP inspection checklist, and NLCP

recordkeeping requirements is 1,517,935

hours, as shown below:

Time per response Number of responses

Total annual

burden (hours)

Custody and Control Form:

Donor ................................................................................................... 5 minutes ......................................... 6,000,000 500,000

Collector .............................................................................................. 4 minutes ......................................... 6,000,000 400,000

Laboratory ........................................................................................... 3 minutes ......................................... 6,000,000 300,000

Medical Review Officer ....................................................................... 3 minutes ......................................... 6,000,000 300,000

Application .................................................................................................. 3 hours ............................................ 5 15

Inspection Checklist ................................................................................... 3 hours ............................................ 140 420

Recordkeeping ........................................................................................... 250 hours ........................................ 70 17,500

Total ................................................................................................. .......................................................... ........................ 1,517,935

Send comments to Beatrice Rouse,

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: January 24, 1997.

Richard Kopanda,

Executive Officer, SAMHSA.

[FR Doc. 97–2318 Filed 1–29–97; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Notice of Receipt of Applications for

Permit

The following applicants have

applied for a permit to conduct certain

activities with endangered species. This

notice is provided pursuant to Section

10(c) of the Endangered Species Act of

1973, as amended (16 U.S.C. 1531, et

seq.):

PRT–802636

Applicant: Parker Creek Ranch, San Antonio

TX.

The applicant requests renewal of a

permit to authorize interstate and

foreign commerce, export, and cull of

excess male barasingha (Cervus

duvauceli), red lechwe (Kobus leche),

and Eld’s brow-antlered deer (Cervus

eldi) from his captive herd for the

purpose of enhancement of survival of

the species. This notice shall cover a

period of three years. Permittee must

apply for renewal annually.

PRT–803337

Applicant: Thomas J. Moore, III, Ingram, TX.

The applicant requests renewal of a

permit to authorize interstate and

foreign commerce, export, and cull of

excess male barasingha (Cervus

duvauceli) from his captive herd for the

purpose of enhancement of survival of

the species. This notice shall cover a

period of three years. Permittee must

apply for renewal annually.

PRT–824266

Applicant: David C. Eldridge, Mt. Zion, IL.

The applicant requests a permit to

import the sport-hunted trophy of one

male bontebok (Damaliscus pygargus

dorcas) culled from a captive herd

maintained under the management

program of the Republic of South Africa,

for the purpose of enhancement of the

survival of the species.

Written data or comments should be

submitted to the Director, U.S. Fish and

Wildlife Service, Office of Management

Authority, 4401 North Fairfax Drive,

Room 430, Arlington, Virginia 22203

and must be received by the Director

within 30 days of the date of this

publication.

Documents and other information

submitted with these applications are

available for review, subject to the

requirements of the Privacy Act and

Freedom of Information Act, by any

party who submits a written request for

a copy of such documents to the

following office within 30 days of the

date of publication of this notice: U.S.

Fish and Wildlife Service, Office of

Management Authority, 4401 North

Fairfax Drive, Room 430, Arlington,

Virginia 22203. Phone: (703/358–2104);

FAX: (703/358–2281).

Dated: January 24, 1997.

Caroline Anderson,

Acting Chief, Branch of Permits, Office of

Management Authority.

[FR Doc. 97–2291 Filed 1–29–97; 8:45 am]

BILLING CODE 4310–55–P

Emergency Exemption: Issuance

On January 22, 1997 the Fish and

Wildlife Service (Service) issued a

permit (PRT–824324) to SOS Care, Inc.,

CA, to export one neonate margay

(Leopardus weidii) born 1/9/97 to

Canada and reimport to the United

States. The 30-day public comment

period required by section 10(c) of the

Endangered Species Act was waived.

The Service determined that an

emergency affecting the survival of the

margay existed and that no reasonable

alternative was available to the

applicant. This animal was at risk

because of the need to remove the

animal from its mother due to weather

extremes and lack of care and the need

for constant care by experienced

personnel during the initial 6 weeks of

life.

Dated: January 24, 1997.

Caroline Anderson,

Acting Chief, Branch of Permits, Office of

Management Authority.

[FR Doc. 97–2290 Filed 1–29–97; 8:45 am]

BILLING CODE 4310–55–P

North American Wetlands

Conservation Act: Request for Small

Grants Proposals for 1997

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of request for proposals.

SUMMARY: The purpose of this notice is

to advise the public that the Fish and

Wildlife Service (Service) is currently

entertaining proposals that request

match funding for wetland conservation

projects under the Small Grants

program. Projects must meet the

purposes of the North American

Wetlands Conservation Act of 1989, as