Privacy Act Documents

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Federal Register / Vol. 67, No. 80 / Thursday, April 25, 2002 / Notices

inducing the expression of therapeutic
genes.
The prospective exclusive license
territory will be worldwide and will be
royalty-bearing. Said license may be
granted within sixty (60) days from the
date of this published notice unless the
NIH receives written evidence and
argument establishing that granting this
license is inconsistent with the terms
and conditions of 35 U.S.C. 209(c)(1)
and 37 CFR 404.7(a)(1)(i).
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response to
this notice will not be made available
for public inspection, and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: April 17, 2002.
Jack Spiegel,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer.
[FR Doc. 02–10117 Filed 4–24–02; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Synthetic Ordered Arrays of
Antigen for the Induction of
Autoantibodies
AGENCY: National Institutes of Health,
Public Health Service, DHHS.
ACTION: Notice.
SUMMARY: This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health (NIH), Department
of Health and Human Services, is
contemplating the grant of an exclusive
license to practice the invention
embodied in United States Patent
Application 09/835,124 and its foreign
equivalents, entitled ‘‘Virus-Like
Particles for the Induction of
Autoantibodies,’’ filed on April 13,
2001, with priority back to U.S. S/N 60/
105,132, filed October 21, 1998, to
LigoCyte Pharmaceuticals, Inc., having a
place of business in Bozeman, Montana.
The patent rights in this invention have
been assigned to the United States of
America.

Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Peter Soukas, Office of Technology
Transfer, National Institutes of Health,
6011 Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; e-mail:
[email protected]; telephone: (301) 496–
7056, ext. 268; facsimile: (301) 402–
0220.
ADDRESSES:

This
invention claims compositions and
methods for producing antibodies to
tolerogens (self-antigens normally
exposed to B cells that fail to induce an
antibody response). The compositions of
the invention comprise multiple copies
of a tolerogen (or at least one B cell
epitope of a tolerogen) chimerized to
capsomeric structures or capsid proteins
in an orderly manner. This invention
could potentially replace any treatment
utilizing chronic administration of a
monoclonal antibody that reacts with a
self-antigen.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7. The prospective
exclusive license may be granted unless,
within 60 days from the date of this
published Notice, NIH receives written
evidence and argument that establishes
that the grant of the license would not
be consistent with the requirements of
35 U.S.C. 209 and 37 CFR 404.7.
The field of use may be limited to
non-Virus-Like Particle (VLP)
polyvalent liposome nanoparticle
vaccines against self-antigens.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response to
this notice will not be made available
for public inspection, and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.

SUPPLEMENTARY INFORMATION:

Dated: April 17, 2002.
Jack Spiegel,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer.
[FR Doc. 02–10116 Filed 4–24–02; 8:45 am]
BILLING CODE 4140–01–P

DATES: Only written comments and/or
application for a license which are
received by the NIH Office of
Technology Transfer on or before June
24, 2002, will be considered.

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Privacy Act of 1974: Establishment of
New Privacy Act System of Records
AGENCY: Substance Abuse and Mental
Health Services Administration
(SAMHSA), DHHS.
ACTION: Privacy Act of 1974: Notice of
new system of records
SUMMARY: The Substance abuse and
mental Health Services Administration
(SAMHSA) is establishing a new system
of records in order to implement the
provisions of the Controlled Substances
Act as amended (21 U.S.C. 823(g)(2)).
SUPPLEMENTARY INFORMATION: New
legislation permits practitioners to seek
waivers from the separate registration
requirements required under the
Controlled Substances Act for
practitioners who use narcotic treatment
medications in the maintenance or
detoxification treatment of opiate
addition. The Secretary of the
Department of Health and Human
Services has delegated to SAMHSA the
responsibility of determining whether
practitioners meet the requirements for
these waivers. To be eligible for waivers,
practitioners must be licensed
physicians, must be registered by Drug
Enforcement Administration (DEA),
must fulfill qualifications for training
and experience, and must make written
certifications about treatment capacity
and patent load. Practitioners
determined eligible for a waiver, will
receive a unique identification number
from DEA, and will be eligible to
prescribe certain approved opioid
treatment medications.
This new system of records will
permit SAMHSA to conduct its
responsibilities to determine whether
practitioners meet requirements for
waivers. SMHSA will use the
information from this system to verify
DEA registration status, to verify
medical license status, and to verify
training and experience qualifications.
In addition, for those practitioners who
consent, SMHSA will use limited
information from this system to
augment the Substance Abuse
Treatment Facility Locator. The
Treatment Facility Locator is a webbased system that permits individuals
seeking treatment to locate treatment
providers.
DATES: SAMHSA invites interested
persons to submit comments on the
proposed new system on or before May
28, 2002. SAMHSA will adopt this new

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Federal Register / Vol. 67, No. 80 / Thursday, April 25, 2002 / Notices
system without further notices on June
10, 2002 unless comments are received
that would result in a contrary
determination.
ADDRESSES: Please address comments to
the SAMHSA Privacy Act Officer,
Division of Administrative Services,
Room 6–101, Parklawn building,
Substance Abuse and Mental Health
Services Administration, 5600 Fishers
Lane, Rockville, Maryland 20857. We
will make comments available for
public inspection at the above address
during normal business hours, 8:30
a.m.–5 p.m.
FOR FURTHER INFORMATION CONTACT:
Nichols Reuter, Supervisory, Public
Health Advisor, Office of Pharmacologic
and Alternative Therapies, Center for
Substance Abuse Treatment/SAMHSA,
5600 Fishers Lane, Rockwall II, suite
740, Rockville, Maryland 20857 (301)
443–0547.
Dated: April 4, 2002.
Richard Kopanda,
Executive Officer, Substance Abuse and
Mental Health Services Administration.
09–30–0052
SYSTEM NAME:

Opioid Treatment Waiver Notification
System.
SECURITY CLASSIFICATION:

None.
SYSTEM LOCATION:

Office of Pharmacologic and
Alternative Therapies, Center for
Substance Abuse Treatment, Substance
Abuse and Mental Health Services
Administration, Room 7–40, Rockwall II
Building, 5600 Fishers Lane, Rockville,
Maryland 20857.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:

An individual practitioner (physician)
or a practitioner in a group practice who
submits a written notification of intent
to use schedule III, IV, V opioid drugs
for the maintenance or detoxification
treatment of opiate addiction under 21
U.S.C. 823(g)(2).
CATEGORIES OF RECORDS IN THE SYSTEM:

Physician name, address, phone,
facsimile, state medical license number,
DEA registration number, credentialing
and specialized training information. In
addition, for those practitioners in
group practices, the group practice EIN.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Controlled Substance Act (21 U.S.C.
823(g)(2)).
PURPOSES(S):

To determine (as required by 21
U.S.C. 823(g)(2)) whether practitioners

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who submit notifications meet all of the
requirements for a waiver under 21
U.S.C. 823(g)(2)(B). The established
criteria for a waiver include: a written
notification that states the practitioner’s
name, the practitioner’s registration
under 21 U.S.C. 823(f), the practitioner’s
physician license under State law, and
the qualifying physician criteria. The
record system will also allow disclosure
with consent of limited information to
the Treatment Facility Locator.
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OF USERS AND
THE PURPOSES OF SUCH USES:

A. Medical speciality societies to
verify practitioner qualifications.
B. Other federal law enforcement and
regulatory agencies for law enforcement
and regulatory purposes.
C. State and local law enforcement
and regulatory agencies for law
enforcement and regulatory purposes.
D. Persons registered under the
Controlled Substance Act (Pub. L. 91–
513) for the purpose of verifying the
registration of customers and
practitioners.
E. Disclosure may be made to a
congressional office from the record of
an individual in response to a verified
inquiry from the congressional office
made at the written request of that
individual.
F. The Department of Health and
Human Services (HHS) may disclose
information from this system of records
to the Department of Justice, or to a
court or other tribunal, when (a) HHS,
or any component thereof; or (b) any
HHS employee in his or her official
capacity; or (c) any HHS employee in
his or her individual capacity where the
Department of Justice (or HHS, where it
is authorized to do so) has agreed to
represent the employee; or (d) the
United States or any agency thereof
where HHS determines that the
litigation is likely to affect HHS or any
of its components, is a party to litigation
or has an interest in such litigation, and
HHS determines that the use of such
records by the Department of Justice, the
court or other tribunal is relevant and
necessary to the litigation and would
help in the effective representation of
the governmental party, provided
however, that in each case, HHS
determines that such disclosure is
compatible with the purpose for which
the records were collected.
G. SAMHSA intends to disclose
information from this system to an
expert, consultant, or contractor
(including employees of the contractor)
of SAMHSA if necessary to further the
implementation and operation of this
program.

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20543

Disclosure limited to individual’s
name, address, and phone number will
also be made to the SAMHSA Treatment
Facility Locator pursuant to express
consent.
DISCLOSURES TO CONSUMER REPORTING
AGENCIES:

None.
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM
STORAGE:

Documents are filed in manual files in
enclosed and/or locked file cabinets and
in secured computers. The same basic
data is maintained in an automated
system for quick retrieval.
RETRIEVABILITY:

Records are retrieved by the
individual practitioner’s name and cross
indexed by the practitioner’s DEA
registration number.
SAFEGUARDS:

1. Authorized Users: Federal contract
and support personnel.
2. Physical Safeguards: All folders are
in file cabinets in a room that is locked
after business hours in a building with
controlled entry (picture identification).
Files are withdrawn from cabinet for
Federal staff who have a need to know
by a sign in and out procedure.
3. Procedural Safeguards: Access to
records is strictly limited to those staff
members trained in accordance with the
Privacy Act.
4. Implementation Guidelines: DHHS
Chapter 45–13 of the General
Administration Manual.
RETENTION AND DISPOSAL:

Records are retained for a period of
five years and then destroyed.
SYSTEM MANAGER(S) AND ADDRESS:

Nicholas Reuter, Office of
Pharmacologic and Alternative
Therapies, Center for Substance Abuse
Treatment, Substance Abuse and Mental
Health Services Administration, Room
6–70, Rockwall II Building, 5600 Fishers
Lane, Rockville, Maryland 20857.
NOTIFICATION PROCEDURES:

To determine if a record exists, write
to the appropriate System Manager at
the Address above or appear in person
to the Division of Contracts
Management. An individual may learn
if a record exists about himself/herself
upon written request with notarized
signature. An individual who is the
subject of records maintained in this
record system may also request an
accounting of all disclosures that have
been made for that individual’s records,
if any.

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Federal Register / Vol. 67, No. 80 / Thursday, April 25, 2002 / Notices

RECORD ACCESS PROCEDURES:

Same as notification procedures.
Requesters should specify the record
contents being sought. An individual
may also request an accounting of
disclosures of his/her records, if any.
CONTESTING RECORD PROCEDURES:

Contact the official at the address
specified under notification procedures
above and identify the record, specify
the information being contested, the
corrective action sought, along with
supporting information to show how the
record is inaccurate, incomplete,
untimely, or irrelevant.
RECORD SOURCE CATEGORIES:

Individual practitioner notifications
of intent to use Schedule III, IV, or V
opioid drugs for the Maintenance and
Detoxification Treatment of Opiate
Addiction under 21 USC § 823(g)(2).
SYSTEM EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:

None.
[FR Doc. 02–10261 Filed 4–24–02; 8:45 am]
BILLING CODE 4162–20–M

DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
Receipt of Applications for Permit
AGENCY: Fish and Wildlife Service,
Interior.
ACTION: Notice of receipt of applications
for permit.
SUMMARY: The public is invited to
comment on the following applications
to conduct certain activities with
endangered species and/or marine
mammals.
DATES: Written data, comments or
requests must be received by May 28,
2002.

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
within 30 days of the date of publication
of this notice to: U.S. Fish and Wildlife
Service, Division of Management
Authority, 4401 North Fairfax Drive,
Room 700, Arlington, Virginia 22203;
fax 703/358–2281.
FOR FURTHER INFORMATION CONTACT:
Division of Management Authority,
telephone 703/358–2104.
SUPPLEMENTARY INFORMATION:
ADDRESSES:

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Endangered Species
The public is invited to comment on
the following application(s) 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.).
Written data, comments, or requests for
copies of these complete applications
should be submitted to the Director
(address above).
PRT–844074
Applicant: George E. Hogan, Jr., Double
H Exotics, Okeechobee, FL.
The applicant requests renewal of his
permit to authorize interstate and
foreign commerce, export, and cull of
excess male barasingha (Cervus
duvauceli) and Arabian oryx (Oryx
leucoryx) from his captive herd for the
purpose of enhancement of survival of
the species. This notice shall cover a
period of five years. Permittee must
apply for renewal annually.
PRT–694126
Applicant: National Institutes of Health/
National Cancer Institute, Frederick,
MD.
The applicant requests an amendment
of their permit authorizing the import of
multiple shipments of biological
samples from wild, captive-held, and/or
captive-born endangered primates
(Primates), bears (Ursidae), and cats
(Felidae), to now include biological
samples from all endangered mammals,
for the purpose of scientific research. No
animals can be intentionally killed for
the purpose of collecting specimens.
Any invasively collected samples can
only be collected by trained personnel.
This notification covers activities
conducted by the applicant over a
period of 5 years.
PRT–055376
Applicant: Lance H. Norris, Nunich, MI.
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.
PRT–055375
Applicant: Thomas P. Tinnin,
Albuquerque, MN.
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,

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for the purpose of enhancement of the
survival of the species.
PRT–673539, 055424, 055425, 055426
Applicant: Gatti Productions, Inc,
Orange, CA.
The applicant request three new
permits and the re-issuance of one
permit to export, re-export, and reimport Asian elephants (Elephas
maximus) and progeny of the animals
currently held by the applicant and any
animals acquired in the United States by
the applicant to/from worldwide
locations to enhance the survival of the
species through conservation education.
This notification covers activities
conducted by the applicant over a three
year period.
PRT–839021
Applicant: Ferdinand and Anton
Hantig, d.b.a. Manimal Magic Act,
Inc, Las Vegas, NV.
The applicant request re-issuance of
their permits to re-export and re-import
tigers (Panthera tigris) and progeny of
the animals currently held by the
applicant and any animals acquired in
the United States by the applicant to/
from worldwide locations to enhance
the survival of the species through
conservation education. This
notification covers activities conducted
by the applicant over a three year
period.
PRT–809348
Applicant: Hawthorn Corporation,
Grayslake, IL.
The applicant request re-issuance/
renewal of their permit to re-export and
re-import Asian elephants (Elephas
maximus) and progeny of the animals
currently held by the applicant and any
animals acquired in the United States by
the applicant to/from worldwide
locations to enhance the survival of the
species through conservation education.
This notification covers activities
conducted by the applicant over a three
year period.
PRT–777744, 812757
Applicant: Hawthorn Corporation,
Grayslake, IL.
The applicant request re-issuance of
their permits to re-export and re-import
tigers (Panthera tigris) and progeny of
the animals currently held by the
applicant and any animals acquired in
the United States by the applicant to/
from worldwide locations to enhance
the survival of the species through
conservation education. This
notification covers activities conducted
by the applicant over a three year
period.

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