51118 Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Notices

Send comments to Deborah Trunzo,

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: September 17, 1997.

Richard Kopanda,

Executive Officer, SAMHSA.

[FR Doc. 97–25849 Filed 9–29–97; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Mandatory Guidelines for Federal

Workplace Drug Testing Programs

AGENCY: Substance Abuse and Mental

Health Services Administration, HHS

ACTION: Revisions to the Mandatory

Guidelines

SUMMARY: On November 16, 1995, the

Department of Health and Human

Services (HHS) published a notice in the

Federal Register at 60 FR 57587

proposing to revise the Mandatory

Guidelines for Federal Workplace Drug

Testing Programs, 59 FR 29916 (June 9,

1994). Specifically, the Department

proposed to change the drug testing

levels for opiate metabolites and to

require the testing for a metabolite of

heroin in urine specimens collected as

part of the Federal Workplace Drug

Testing Program. After considering the

comments, this Department is revising

the Mandatory Guidelines to add such

requirements. The goals of the revised

new opiate testing policy are to

substantially reduce the total number of

specimens laboratories report positive

for opiates that Medical Review Officers

verify as negative, to shift the emphasis

of testing for opiates back to the proper

deterrence and detection of heroin use,

and to reduce any unnecessary/

excessive costs to drug testing without

compromising the original drug

deterrent objectives.

EFFECTIVE DATE: May 1, 1998.

FOR FURTHER INFORMATION CONTACT: Dr.

Donna M. Bush, Chief, Drug Testing

Section, Division of Workplace

Programs, SAMHSA/CSAP, Room 13A–

54, 5600 Fishers Lane, Rockville,

Maryland 20857, tel. (301) 443–6014.

SUPPLEMENTARY INFORMATION: After

considering comments received from

the public, the Department is revising

the guidelines entitled ‘‘Mandatory

Guidelines for Federal Workplace Drug

Testing Program,’’ (Mandatory

Guidelines) which were initially

published in the Federal Register on

April 11, 1988 (53 FR 11979) and

revised on June 9, 1994 (59 FR 29908).

This revision and the Mandatory

Guidelines are developed in accordance

with Executive Order 12564 dated

September 15, 1986, and section 503 of

Public Law 100–71, 5 U.S.C. section

7301 note, the Supplemental

Appropriations Act for fiscal year 1987

dated July 11, 1987. This revision

incorporates changes based on the

comments received during the public

comment period and the Department’s

experience in implementing and

administering these Mandatory

Guidelines.

Background and Summary of Public

Comments

A. Proposed Changes to the Testing

Cutoff Levels for Opiates

The changes proposed in the notice

published in the Federal Register on

November 16, 1995, 60 FR 57587, are

summarized here to facilitate the

discussion of the comments received

during the public comment period.

The Department proposed increasing

the initial testing cutoff level for opiate

metabolites and the confirmatory testing

cutoff levels for morphine and codeine

from 300 ng/mL to 2,000 ng/mL and

establishing a new requirement to test

for 6-acetylmorphine (6–AM), a

metabolite that comes only from heroin,

using a 10 ng/mL confirmatory level for

specimens that have tested positive on

the initial test.

The Department evaluated results on

1.1 million urine specimens tested for

opiates in five certified laboratories and

317,500 specimens that were reviewed

by three Medical Review Officer (MRO)

groups. Based on the information

obtained from the MROs, 87% of all

opiate positives reported by the

laboratories were verified as negatives

by the MROs. The reasons given for

reporting negative results included the

use of prescription medications, poppy

seed consumption, no clinical evidence

of heroin use, or other unspecified

reason. The reversal of most opiate

positive results clearly indicates that the

current opiate testing cutoff levels used

by the laboratories are identifying too

many individuals who are not opiate

abusers. The 300 ng/mL testing levels

had been selected to provide the greatest

opportunity to identify anyone who may

have used heroin. However, many who

have not used heroin but had taken a

prescribed codeine or morphine

medication or eaten poppy seeds (which

may contain morphine and/or codeine)

have also tested positive. Since the

purpose of the workplace drug testing

program is to deter and detect use of

illegal drugs, establishing the testing

cutoff levels for opiates at these higher

levels will eliminate the identification

of most individuals who are legitimately

taking prescription medications that

contain morphine or codeine or have

ingested poppy seeds.

With regard to testing for 6–AM, the

laboratory results indicate that of the

approximately 1.1 million specimens

tested, 7294 specimens were reported

positive for codeine and/or morphine.

Within this group of 7294 opiate

positives, 848 were also tested for 6–AM

and 16 of these 848 were reported

positive for 6–AM. Of particular

interest, was that 14 of these 16 6–AM

positives had morphine concentrations

greater than 2,000 ng/mL. In light of

these results, the Department proposed

to establish a requirement to test for 6–

AM in specimens positive for opiates on

the initial test because of the increased

probability of detecting 6–AM when the

morphine concentration was greater

than 2000 ng/mL. Since 6–AM has a

very short half-life (i.e., detectable for

only a few hours after heroin use), it is

essential that a laboratory use a

sensitive analytical procedure to test for

6–AM. From the data available, it

appears 10 ng/mL is the lowest testing

level that can reasonably be used to

consistently and accurately identify and

quantitate the presence of 6–AM.

The Department believes that raising

the testing levels for opiates and

establishing a requirement to test for 6–

AM will not reduce the deterrent value

of the Federal Workplace Drug Testing

Program. Additionally, the cost to

Federal agencies may be reduced since

there will be fewer specimens screened

positive for opiates, fewer specimens

sent to confirmatory testing, and fewer

opiate positive results requiring

extensive MRO review.

B. Public Comments and the

Department’s Response

The Department received 22 public

comments on the proposed changes to

the testing levels for opiates from

individuals, companies, and

laboratories. More than 50% of the

commenters supported all or part of the

proposed changes, while five

commenters disagreed with the entire

proposal. The remaining commenters

expressed concern only with the

implementation of a new policy and did

not provide any comments to either

support or disagree with the proposed

changes. All written comments were

reviewed and taken into consideration

in setting the new testing levels. The

substantive concerns raised in the
Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Notices 51119

4Test for 6-AM when the morphine concentration

exceeds 2,000 ng/mL.

public comments and the Department’s

responses to the comments are

discussed below. Similar comments are

considered together.

1. Raising the Initial Testing Cutoff

Level

More than 50% of the commenters

supported raising the initial testing level

for opiates as proposed. They agreed

that the current initial testing level was

unnecessarily identifying a large

number of specimens as positive for

opiates that were verified negative by

the Medical Review Officer (MRO). Five

commenters, however, were opposed to

raising the initial testing level because

it would no longer identify a number of

individuals that misuse prescription

medications that contain morphine or

codeine. The Department recognizes

that a very small percentage of

individuals who abuse opiates that are

currently reported positive using the

300 ng/mL initial test level would no

longer be reported positive. However,

the Department believes that the

benefits from not reporting a large

number of positives that are verified as

negatives by an MRO outweigh the

small risk of not detecting misuse of

prescription drugs.

One commenter opposed deleting the

footnote that had established an initial

testing level of 25 ng/mL for free

morphine and suggested a new level be

established by applying the same factor

that was used for the proposed opiate

testing level. The Department disagrees

with this comment. Since heroin,

codeine, and morphine are excreted as

varying concentrations of unchanged

drug, glucuronide conjugates, and other

metabolites, the Department believes it

is more appropriate to use initial test

kits that have a cross-reactivity with

these metabolites rather than using a

test kit that only detects free morphine.

Because of this cross-reactivity, the

Department believes it is appropriate to

continue to list the initial test level as

‘‘opiate metabolites’’ rather than as

morphine.

One commenter agreed that the initial

test level should be raised, but

suggested that the Department specify

the analyte to be used for the test kit

calibrators, that is, either morphine,

morphine-3-glucuronide, or codeine.

The Department agrees that the specific

analyte used to calibrate a test kit has a

direct impact on its ability to detect the

presence of a drug or metabolite in a

urine specimen. Therefore, test kit

manufacturers should continue using

morphine to prepare the calibrators for

the revised opiate test kits as they had

been using for the current opiate test

kits.

2. Raise the Confirmatory Test Levels for

Morphine and Codeine

The majority of the commenters

agreed that raising the confirmatory test

levels for morphine and codeine was

appropriate and that the levels should

correspond to the level established for

the initial test. However, two

commenters suggested that the

confirmatory test level for morphine be

raised to 4,000 ng/mL to make the test

level consistent with that established by

the Department of Defense (DoD) for its

testing program. The Department does

not agree that the two programs must

use the same confirmatory testing levels.

In light of the information found in the

study of 1.1 million specimens noted

above, the Department believes that the

2,000 ng/mL is the cutoff level that

should be used at this time for agency

testing.

3. Establish a Confirmatory Test Level

for 6-Acetylmorphine

A majority of the commenters

supported establishing a confirmatory

test level for 6-acetylmorphine (6-AM);

however, there was disagreement that it

should be tested for on each specimen

that was positive on the initial test.

There were suggestions that a laboratory

only test for 6-AM when the morphine

concentration exceeds 2,000 or 4,000

ng/mL, or when the MRO requests a 6-

AM analysis. Several commenters stated

that testing for 6-AM on all presumptive

positives places an unnecessary burden

on the laboratory to conduct a second

separate confirmatory test which will

increase the cost of testing. In addition,

there were suggestions that presumptive

positives be tested only for 6-AM since

the focus of the opiate testing is to

identify heroin use. The Department

believes that since the number of

presumptive positives going to

confirmation testing at a 2,000 ng/mL

initial test level will be reduced

significantly, there will not be a

significant increase in the cost

associated with testing for 6-AM.

However, we do agree that testing for 6-

AM on each presumptive positive may

be unnecessary. Based on the

pharmacology of heroin metabolism, 6-

AM is likely present only when

morphine is present in the specimen

and its concentration exceeds 2,000 ng/

mL. The concentration of codeine has

no bearing on the possible presence of

6-AM. Therefore, the Department agrees

with the commenters that 6-AM should

only be tested for after a laboratory

confirms that the morphine

concentration exceeds 2,000 ng/mL

rather than testing for 6-AM on each

specimen that was positive on the initial

test as had been proposed. In other

words, a positive codeine without

morphine present or with morphine less

than 2,000 ng/mL will not automatically

require a test for 6-AM. The final

revisions to the Mandatory Guidelines

have been changed accordingly.

4. Implementation

Several commenters expressed

concern that the new testing levels

could not be implemented immediately

because the test kit manufacturers will

need sufficient time to reformulate their

kits and to get them cleared by the Food

and Drug Administration (FDA).

Additionally, the laboratories will need

time to validate new confirmatory test

procedures using the new testing levels.

The Department agrees that a sufficient

time must be allowed for the new levels

to be implemented and, therefore, the

effective date is 180 days from the date

of this publication.

Information Collection Requirements:

There are no new paperwork

requirements subject to the Office of

Management and Budget approval

under the Paperwork Reduction Act of

1980.

Dated: April 18, 1997.

Nelba Chavez,

Administrator, Substance Abuse and Mental

Health Services Administration.

Dated: June 11, 1997.

Donna E. Shalala,

Secretary.

The following amendments are made

to the Mandatory Guidelines for Federal

Workplace Drug Testing Programs

published on June 9, 1994 (59 FR

29916):

Subpart B

1. Section 2.4(e)(1), the initial test

level for opiate metabolites appearing in

the table, is amended by changing the

value of ‘‘300’’ to ‘‘2,000’’ and deleting

the footnote that had specified a 25 ng/

mL testing level if the immunoassay test

was specific for free morphine.

2. Section 2.4(f)(1), the confirmatory

test level for morphine appearing in the

table, is amended by changing the value

of ‘‘300’’ to ‘‘2,000.’’

3. Section 2.4(f)(1), the confirmatory

test level for codeine appearing in the

table, is amended by changing the value

of ‘‘300’’ to ‘‘2,000.’’

4. Section 2.4(f)(1), the table of

confirmatory test levels, is amended by

adding a new line under opiates to read

as follows:

6-Acetylmorphine 4 10 ng/mL

5. Section 2.4(f)(1), the table of

confirmatory test levels, is amended by
51120 Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Notices

adding a new footnote under the table

to read as follows:

[FR Doc. 97–25823 Filed 9–29–97; 8:45 am]

BILLING CODE 4160–20–U

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4285–N–01]

Debenture Recall

AGENCY: Office of the Assistant

Secretary for Housing-Federal Housing

Commissioner, HUD.

ACTION: Notice.

SUMMARY: This notice announces a

debenture recall of certain Federal

Housing Administration debentures, in

accordance with authority provided in

the National Housing Act.

FOR FURTHER INFORMATION CONTACT:

Richard Keyser, Room B133,

Department of Housing and Urban

Development, 451 Seventh Street, S.W.,

Washington, D.C. 20410, telephone

(202) 755–7510. This is not a toll-free

number.

SUPPLEMENTARY INFORMATION: Pursuant

to Section 207(j) of the National

Housing Act, 12 U.S.C. 1713(j), and in

accordance with HUD regulations at 24

CFR 207.259(e)(3), the Federal Housing

Commissioner, with approval of the

Secretary of the Treasury, announces

the call of all Federal Housing

Administration debentures, with a

coupon rate of 6.75% or above, except

for those debentures subject to

‘‘debenture lock agreements,’’ that have

been registered on the books of the

Federal Reserve Bank of Philadelphia,

and are, therefore, ‘‘outstanding’’ as of

September 30, 1997. The date of the call

is January 1, 1998.

The debenture will be redeemed at

par plus accrued interest. Interest will

cease to accrue on the debentures as of

the call date. Final interest on any

called debentures will be paid with the

principal at redemption. During the

period from the date of this notice to the

call date, debentures that are subject to

the call may not be used by the

mortgagee for a special redemption

purchase in payment of a mortgage

insurance premium.

No transfer of debentures covered by

the foregoing call will be made on the

books maintained by the Treasury

Department on or after October 1, 1997.

This does not affect the right of the

holder of a debenture to sell or assign

the debenture on or after this date.

Payment of final principal and interest

due on January 1, 1998, will be made

automatically to the registered holder.

Dated: September 25, 1997.

Nicolas P. Retsinas,

Assistant Secretary for Housing-Federal

Housing Commissioner.

[FR Doc. 97–25985 Filed 9–29–97; 8:45 am]

BILLING CODE 4210–27–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Endangered and Threatened Species

Permit Applications

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of receipt of applications.

The following applicants have

applied for permits 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–834589

Applicant: R.D. Zande & Associates,

Inc., Columbus, Ohio; Robert F. Madej,

principal investigator.

The applicant requests a permit to

take (capture and release; survey

hibernacula) gray bat (Myotis grisescens)

and Indiana bat (Myotis sodalis); take

(capture and release; collect one

voucher specimen per site) American

burying (=giant carrion) beetle

(Nicrophorus americanus); take (capture

and release) Hine’s (=Ohio) emerald

dragonfly (Somatochlora hineana); and

take (survey habitat) Mitchell’s satyr

butterfly (Neonympha mitchellii

mitchellii) throughout their ranges.

Activities are proposed to document

presence or absence of the species for

the purpose of survival and

enhancement of the species in the wild.

PRT–834596

Applicant: 3D/International, Inc.

Environmental Group, Cincinnati, Ohio.

The applicant requests a permit to

take (capture and release; collect empty

shells) clubshell mussel (Pleurobema

clava) and northern riffleshell mussel

(Epioblasma torulosa rangiana) and to

take (capture and release) American

burying (=giant carrion) beetle

(Nicrophorus americanus) and Hine’s

(=Ohio) emerald dragonfly

(Somatochlora hineana) at Wright

Patterson Air Force Base, Ohio.

Activities are proposed to document

presence or absence of the species for

the purpose of survival and

enhancement of the species in the wild.

Written data or comments should be

submitted to the Regional Director, U.S.

Fish and Wildlife Service, Ecological

Services Operations, 1 Federal Drive,

Fort Snelling, Minnesota 55111–4056,

and must be received on or before

October 30, 1997.

Documents and other information

submitted with these applications are

available for review 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, Ecological Services Operations,

1 Federal Drive, Fort Snelling,

Minnesota 55111–4056. Telephone:

(612/725–3536 x224); FAX: (612/725–

3526).

Dated: September 26, 1997.

John A. Blankenship,

Assistant Regional Director, IL, IN, MO

(Ecological Services), Region 3, Fort Snelling,

Minnesota.

[FR Doc. 97–25908 Filed 9–29–97; 8:45 am]

BILLING CODE 4310–55–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Availability of Draft Recovery Plan for

Oahu Plants

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of document availability.

SUMMARY: The U.S. Fish and Wildlife

Service (Service) announces the

availability for public review of a draft

Recovery Plan for Oahu Plants. There

are 66 plant taxa included in this plan,

all listed as endangered. All 66 taxa are

endemic to Hawaii. Sixty are restricted

to the island of Oahu and six occur on

Oahu and other main Hawaiian Islands.

DATES: Comments on the draft recovery

plan received by December 29, 1997

will be considered by the Service.

ADDRESSES: Copies of the draft recovery

plan are available for inspection, by

appointment, during normal business

hours at the following locations: U.S.

Fish and Wildlife Service, Pacific

Islands Office, 300 Ala Moana

Boulevard, Room 3108, Box 50088,

Honolulu, Hawaii 96850 (phone 808/

541–3441); and Hawaii State Library,

478 S. King Street, Honolulu, Hawaii

96813. Requests for copies of the draft

recovery plan and written comments

and materials regarding this plan should

be addressed to Brooks Harper, Field

Supervisor, Ecological Services, at the

above Honolulu address.

FOR FURTHER INFORMATION CONTACT:

Scott Johnston, Fish and Wildlife

Biologist, at the above Honolulu

address.