36927
Federal
Register
/
Vol.
68,
No.
119
/
Friday,
June
20,
2003
/
Rules
and
Regulations
Dated:
June
12,
2003.
James
W.
Newsom,
Acting
Regional
Administrator,
EPA
Region
III.
[
FR
Doc.
03
 
15661
Filed
6
 
19
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
761
[
OPPT
 
2003
 
0029;
FRL
 
7314
 
2]

RIN
2070
 
AC01
Polychlorinated
Biphenyls;
Use
of
Porous
Surfaces;
Amendment
in
Response
to
Court
Decision
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
EPA
is
revising
the
language
of
the
regulations
affecting
the
use
of
polychlorinated
biphenyls
(
PCBs)
in
the
Code
of
Federal
Regulations
(
CFR)
to
conform
to
a
court
decision
vacating
an
amendment
to
these
regulations.
EPA's
1998
amendments
to
the
PCB
disposal
regulations
added
a
use
authorization
for
porous
materials
contaminated
by
spills
of
liquid
PCBs.
Due
to
an
editing
error,
the
regulation
referred
to
a
unit
of
measurement
inapplicable
to
the
concentration
of
PCBs
in
liquids.
In
1999,
EPA
issued
a
final
rule
correcting
a
number
of
errors
in
the
1998
action,
including
the
porous
surfaces
use
authorization.
On
January
30,
2001,
the
United
States
Court
of
Appeals
for
the
District
of
Columbia
Circuit
(
the
Court)
vacated
the
portion
of
the
1999
amendment
which
pertained
to
the
porous
materials
use
authorization.
This
document
revises
the
CFR
to
conform
to
the
court
decision,
and
requires
no
notice
and
public
comment.
DATES:
This
final
rule
is
effective
on
June
20,
2003.

FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Director,
Environmental
Assistance
Division
(
7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
554
 
1404;
e­
mail
address:
TSCAHotline
epa.
gov.
For
technical
information
contact:
Sara
McGurk,
National
Program
Chemicals
Division
(
7404T),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
566
 
0480;
e­
mail
address:
mcgurk.
sara@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?
You
may
be
potentially
affected
by
this
action
if
you
manufacture,
process,
distribute
in
commerce,
use,
or
dispose
of
PCBs
or
materials
containing
PCBs.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Oil
and
Gas
Extraction
(
NAICS
21111),
e.
g.,
Facilities
with
surfaces
contaminated
by
PCBs
 
Electric
Power
Generation,
Transmission
and
Distribution
(
NAICS
2211),
e.
g.,
Facilities
with
surfaces
contaminated
by
PCBs
 
Construction
(
NAICS
23),
e.
g.,
Facilities
with
surfaces
contaminated
by
PCBs
 
Food
Manufacturing
(
NAICS
311),
e.
g.,
Facilities
with
surfaces
contaminated
by
PCBs
 
Paper
Manufacturing
(
NAICS
322),
e.
g.,
Facilities
with
surfaces
contaminated
by
PCBs
 
Petroleum
and
Coal
Products
Manufacturing
(
NAICS
324),
e.
g.,
Facilities
with
surfaces
contaminated
by
PCBs
 
Chemical
Manufacturing
(
NAICS
325),
e.
g.,
Facilities
with
surfaces
contaminated
by
PCBs
 
Primary
Metal
Manufacturing
(
NAICS
331),
e.
g.,
Facilities
with
surfaces
contaminated
by
PCBs
 
Rail
Transportation
(
NAICS
48211),
e.
g.,
Facilities
with
surfaces
contaminated
by
PCBs
 
Lessors
of
Real
Estate
(
NAICS
5311),
e.
g.,
Facilities
with
surfaces
contaminated
by
PCBs
 
Waste
Treatment
and
Disposal
(
NAICS
5622),
e.
g.,
Facilities
with
surfaces
contaminated
by
PCBs
 
Public
Administration
(
NAICS
92),
e.
g.,
Facilities
with
surfaces
contaminated
by
PCBs
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions
in
40
CFR
part
761.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPPT
 
2003
 
0029.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
EPA
Docket
Center,
Rm.
B102
 
Reading
Room,
EPA
West,
1301
Constitution
Ave.,
NW.,
Washington,
DC.
The
EPA
Docket
Center
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
EPA
Docket
Center
Reading
Room
telephone
number
is
(
202)
566
 
1744
and
the
telephone
number
for
the
OPPT
Docket,
which
is
located
in
EPA
Docket
Center,
is
(
202)
566
 
0280.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
761
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr761_
00.
html,
a
beta
site
currently
under
development.
To
access
information
about
PCBs,
go
directly
to
the
PCB
Home
Page
for
the
Office
of
Pollution
Prevention
and
Toxics
at
http://
www.
epa.
gov/
pcb.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
A.
What
Action
is
the
Agency
Taking?
EPA
is
amending
the
regulation
at
40
CFR
761.30(
p)
that
governs
the
continued
use
of
porous
surfaces
contaminated
by
spills
of
liquid
PCBs
to
reflect
a
decision
from
the
Court
in
VerDate
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16:
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RECEIVED
OPPT
NCIC
2003
JUN20
7:
24AM
36928
Federal
Register
/
Vol.
68,
No.
119
/
Friday,
June
20,
2003
/
Rules
and
Regulations
Utility
Solid
Waste
Activities
Group
v.
EPA,
236
F3d
749
(
D.
C.
Cir.
2001).

B.
What
is
the
Agency's
Authority
for
Taking
this
Action?
The
authority
for
issuing
40
CFR
761.30(
p)
was
section
6(
e)(
2)
of
the
Toxic
Substances
Control
Act
(
TSCA),
15
U.
S.
C.
2605(
e)(
2).
This
amendment
is
issued
pursuant
to
a
decision
of
the
Court.
Section
6(
e)
of
TSCA,
15
U.
S.
C.
2605(
e),
specifically
regulates
PCBs.
It
bans
the
manufacture,
processing,
distribution
in
commerce,
or
use
of
PCBs
in
other
than
a
``
totally
enclosed
manner,''
unless
the
activity
is
specifically
authorized
by
EPA
through
rulemaking.
In
order
to
authorize
any
of
these
activities,
EPA
must
make
an
affirmative
finding
that
the
activity
does
not
pose
an
unreasonable
risk
of
injury
to
health
or
the
environment.
Comprehensive
regulations
addressing
the
manufacture,
processing,
distribution
in
commerce,
use,
and
disposal
of
PCBs
were
promulgated
by
EPA
in
1979
and
codified
at
40
CFR
part
761.

C.
What
is
the
History
of
this
Action?
On
December
6,
1994,
EPA
proposed
extensive
revisions
to
the
PCB
regulations.
Some
of
the
commenters
on
this
proposal
asked
EPA
to
consider
including
an
authorization
for
the
use
of
porous
surfaces
that
had
been
contaminated
by
old
PCB
spills.
EPA
considered
the
information
submitted
by
the
commenters
and
decided
to
include
such
a
use
authorization
in
the
final
amendments
to
the
PCB
regulations
published
in
the
Federal
Register
issue
of
June
29,
1998
(
63
FR
35384)
(
FRL
 
5726
 
1)
EPA
determined
that
the
continued
use
of
porous
surfaces
cleaned,
sealed,
and
marked
in
accordance
with
the
requirements
of
40
CFR
761.30(
p)
does
not
pose
an
unreasonable
risk
of
harm
to
human
health
and
the
environment.
EPA
had
intended
to
apply
the
cleaning,
sealing,
and
marking
requirements
in
this
new
provision
of
the
regulations
to
use
of
all
porous
surfaces
that
had
been
contaminated
by
spills
of
liquids
containing
PCBs
at
levels
greater
than
or
equal
to
50
parts
per
million
(
ppm),
regardless
of
the
residual
contamination
level
on
the
surface
of
the
material.
This
is
the
standard
EPA
historically
has
used
to
trigger
the
regulation
of
PCB
disposal.
Unfortunately,
due
to
an
editing
error,
the
1998
version
of
40
CFR
761.30(
p)
referred
to
a
unit
of
measurement
inapplicable
to
the
concentration
of
PCBs
in
liquids.
Instead
of
the
50
ppm
standard
for
this
use
authorization,
the
1998
final
rule
referred
to
``>
10
µ
g/
100
cm2.''
Shortly
after
the
1998
final
rule
was
published,
EPA
discovered
this
and
several
other
errors.
EPA
posted
a
list
of
the
errors
and
appropriate
corrections
on
its
Internet
site
and,
on
June
24,
1999,
in
the
Federal
Register
(
64
FR
33755)
(
FRL
 
6072
 
4),
promulgated
these
corrections
in
a
final
rule
without
prior
notice
and
comment.
The
Utility
Solid
Waste
Activities
Group
and
others
challenged
the
1999
amendment
to
40
CFR
761.30(
p),
arguing
that
EPA
had
failed
to
follow
requisite
procedures
by
issuing
the
amendment
without
notice
and
comment.

D.
What
is
the
Basis
for
this
Action?
On
January
30,
2001,
the
Court
vacated
the
correction
to
40
CFR
761.30(
p).
Utility
Solid
Waste
Activities
Group
v.
EPA,
236
F3d
749
(
D.
C.
Cir.,
2001)
The
Court
determined
that
EPA
was
required
to
promulgate
the
correction
through
full
notice
and
comment
rulemaking
procedures
consistent
with
section
553
of
the
Administrative
Procedures
Act
(
APA)
(
5
U.
S.
C.
553).
Accordingly,
EPA
is
issuing
this
document
to
revise
the
language
of
40
CFR
761.30(
p)
to
conform
to
the
Court's
decision.
The
regulation
at
40
CFR
761.30(
p)
will
now
read
as
published
in
1998.
However,
EPA
continues
to
believe
that
the
1999
amendment
of
40
CFR
761.30(
p)
is
the
appropriate
approach
for
the
continued
use
of
porous
surfaces
contaminated
by
spills
of
liquid
PCBs.
The
Agency
intends
to
issue
a
proposal
in
the
near
future
to
amend
40
CFR
761.30(
p).

III.
Statutory
and
Executive
Order
Reviews
This
action
amends
40
CFR
part
761
to
conform
to
a
decision
by
the
Court.
Under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993),
this
action
is
not
a
``
significant
regulatory
action''
and
is
therefore
not
subject
to
review
by
the
Office
of
Management
and
Budget.
In
addition,
this
action
does
not
impose
any
enforceable
duty,
contain
any
unfunded
mandate,
or
impose
any
significant
or
unique
impact
on
small
governments
as
described
in
the
Unfunded
Mandates
Reform
Act
of
1995
(
Public
Law
104
 
4).
This
action
does
not
involve
special
consideration
of
environmental
justice­
related
issues
as
required
by
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994).
Because
this
action
is
not
subject
to
notice
and
comment
requirements
under
the
APA
or
any
other
statute,
it
is
not
subject
to
the
regulatory
flexibility
provisions
of
the
Regulatory
Flexibility
Act
(
5
U.
S.
C.
601
et
seq.).
This
action
also
is
not
subject
to
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997),
because
EPA
interprets
Executive
Order
13045
as
applying
only
to
those
regulatory
actions
that
are
based
on
health
or
safety
risks,
such
that
the
analysis
required
under
section
5
 
501
of
the
Executive
order
has
the
potential
to
influence
the
regulation.
This
action
is
not
subject
to
Executive
Order
13045
because
it
does
not
establish
any
environmental
standards
intended
to
mitigate
health
or
safety
risks.
This
action
does
not
involve
technical
standards
and
therefore
is
not
subject
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995,
15
U.
S.
C.
272
note.
This
final
rule
does
not
have
federalism
implications
and,
therefore,
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999),
does
not
apply.
This
action
does
not
involve
or
impose
any
requirements
that
affect
Indian
Tribes,
so
the
requirements
of
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
62749,
November
6,
2000),
are
not
applicable.
This
final
rule
is
not
subject
to
Executive
Order
13211,
entitled
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001),
because
it
is
not
a
significant
regulatory
action
under
Executive
Order
12866.
Finally,
this
action
is
not
subject
to
the
Paperwork
Reduction
Act,
44
U.
S.
C.
3501
et
seq.,
because
it
does
not
impose
any
monitoring,
reporting,
or
recordkeeping
requirements.
EPA's
compliance
with
the
statutes
and
Executive
orders
for
the
underlying
Disposal
Amendments
rule
is
discussed
in
the
June
29,
1998,
Federal
Register
(
63
FR
35384).

IV.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
Agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
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36929
Federal
Register
/
Vol.
68,
No.
119
/
Friday,
June
20,
2003
/
Rules
and
Regulations
States
prior
to
publication
of
the
rule
in
the
Federal
Register.
This
rule
conforms
40
CFR
part
761
to
a
decision
by
the
Court
and
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
761
Environmental
protection,
Hazardous
substances,
Labeling,
Polychlorinated
biphenyls
(
PCBs),
Reporting
and
recordkeeping
requirements.

Dated:
June
13,
2003.
Stephen
L.
Johnson,
Assistant
Administrator
for
Prevention,
Pesticides
and
Toxic
Substances.


Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
761
 
[
AMENDED]


1.
The
authority
citation
for
part
761
continues
to
read
as
follows:

Authority:
15
U.
S.
C.
2605,
2607,
2611,
2614,
and
2616.


2.
Amend
§
761.30(
p)(
1)
by
revising
the
introductory
text
to
read
as
follows:

§
761.30
Authorizations.

*
*
*
*
*
(
p)
*
*
*
(
1)
Any
person
may
use
porous
surfaces
contaminated
by
spills
of
liquid
PCBs
at
concentrations
>
10
µ
g/
100
cm2
for
the
remainder
of
the
useful
life
of
the
surfaces
and
subsurface
material
if
the
following
conditions
are
met:
*
*
*
*
*

[
FR
Doc.
03
 
15668
Filed
6
 
19
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
DEPARTMENT
OF
HEALTH
AND
HUMAN
SERVICES
45
CFR
Part
46
Waiver
of
the
Applicability
of
Certain
Provisions
of
Department
of
Health
and
Human
Services
Regulations
for
Protection
of
Human
Research
Subjects
for
Department
of
Health
and
Human
Services
Conducted
or
Supported
Epidemiologic
Research
Involving
Prisoners
as
Subjects
AGENCY:
Department
of
Health
and
Human
Services,
Office
of
the
Secretary,
Office
of
Public
Health
and
Science,
Office
for
Human
Research
Protections.
ACTION:
Final
action
on
waiver.

SUMMARY:
In
a
document
published
in
the
Federal
Register
on
October
7,
2002
(
67
FR
62432),
the
Secretary
of
Health
and
Human
Services
sought
public
comment
on
a
proposed
waiver
of
the
applicability
of
certain
requirements
of
the
Department
of
Health
and
Human
Services
(
DHHS
or
Department)
regulations
for
the
protection
of
human
subjects,
45
CFR
part
46,
to
allow
DHHS
to
conduct
or
support
certain
important
and
necessary
epidemiologic
research
on
prisoners
that
presents
no
more
than
minimal
risk
and
no
more
than
inconvenience
to
the
prisoner­
subjects.
Pursuant
to
his
authority
under
45
CFR
46.101(
i),
the
Secretary
proposed
the
waiver
of
§
§
46.305(
a)(
l)
and
46.306(
a)(
2)
of
the
DHHS
regulations
for
the
protection
of
human
subjects,
which
sections
set
forth
specific
requirements
for
any
research
involving
prisoners
that
is
conducted
or
supported
by
DHHS.
After
consideration
of
the
public
comments
received,
the
Secretary
is
granting
this
waiver.
DATES:
The
waiver
is
effective
June
20,
2003.
FOR
FURTHER
INFORMATION
CONTACT:
Irene
Stith­
Coleman,
Ph.
D.,
Office
for
Human
Research
Protections
(
OHRP),
The
Tower
Building,
1101
Wootton
Parkway,
Suite
200,
Rockville,
MD
20852;
telephone
301
 
496
 
7005;
e­
mail
istithco(
osophs.
dhhs.
gov.
SUPPLEMENTARY
INFORMATION:

Regulatory
Background
The
Department
of
Health
and
Human
Services
(
DHHS)
regulates
research
involving
human
subjects
conducted
or
supported
by
DHHS
through
regulations
codified
at
45
CFR
part
46.
Subpart
C
of
45
CFR
part
46,
entitled
``
Additional
DHHS
Protections
Pertaining
to
Biomedical
and
Behavioral
Research
Involving
Prisoners
as
Subjects,''
provides
additional
regulatory
protections
to
prisoners
who
are
research
subjects.
Subpart
C
sets
forth
specific
requirements
for
any
research
involving
prisoners
as
subjects
that
is
conducted
or
supported
by
DHHS.
Subpart
C
lists
four
categories
of
research
involving
prisoners
as
subjects
that
may
be
conducted
or
supported
by
DHHS.
Sections
45
CER
46.305(
a)(
l)
and
46
306(
a)(
2)
require
that
the
institutional
review
board
(
TRB)
reviewing
the
research
and
the
Secretary,
respectively,
determine
that
the
research
involving
prisoners
represent
one
of
these
four
categories.
The
first
three
categories,
§
§
46.306(
a)(
2)(
i),
(
ii),
and
(
iii),
require
that
the
research
target
either
(
i)
the
possible
causes,
effects,
or
processes
of
incarceration
and
of
criminal
behavior;
(
ii)
the
prison
as
an
institution
or
prison
life;
or
(
iii)
conditions
particularly
affecting
prisoners
as
a
class.
The
fourth
category,
§
46.306(
a)(
2)(
iv),
permits
research
on
practices
which
have
the
intent
and
reasonable
probability
of
improving
the
health
or
well­
being
of
the
prisoner­
subject.

DHHS
Conducted
or
Supported
Epidemiologic
Research
DHHS
conducts
or
supports
certain
epidemiologic
studies
in
which
the
purposes
are
as
follows:
(
1)
To
describe
the
prevalence
or
incidence
of
a
disease
by
identifying
all
cases,
and
(
2)
To
study
potential
risk
factor
associations
for
a
disease.
For
most
such
studies,
the
institutional
review
board
(
IRB)
reviewing
the
study
determines
that
the
research
at
issue
involves
no
more
than
minimal
risk
and
no
more
than
inconvenience
to
the
subjects.
The
human
participants
in
this
type
of
public
health
research
may
include
prisoners
in
the
study
population.
State
health
agencies
are
most
commonly
the
conduits
for
this
type
of
research.
Because
certain
epidemiologic
studies
conducted
or
supported
by
DHHS
focus
on
a
particular
condition
or
disease
that
might
affect
prisoners
as
it
would
any
other
members
of
the
general
population,
such
studies
do
not
meet
any
of
the
four
categories
of
permissible
research
under
subpart
C,
45
CFR
part
46.

Proposed
Waiver
Pursuant
to
45
CFR
46.101(
i),
the
Secretary
of
DHHS
has
the
authority
to
waive
the
applicability
of
some
or
all
of
the
provisions
of
the
DHHS
regulations
for
the
protection
of
human
subjects
to
specific
research
activities
or
classes
of
research
activities
otherwise
covered
by
the
regulations.
In
a
document
published
in
the
Federal
Register
on
October
7,
2002
(
67
FR
62432),
the
Secretary
of
DHHS
sought
public
comment
on
a
proposed
waiver
of
the
applicability
of
certain
requirements
of
subpart
C,
45
CFR
part
46,
to
allow
DHHS
to
conduct
or
support
certain
important
and
necessary
epidemiologic
research
on
prisoners
that
presents
no
more
than
minimal
risk
and
no
more
than
inconvenience
to
the
prisonersubjects
The
Secretary
of
DHHS
specifically
proposed
waiving
the
applicability
of
45
CFR
46.305(
a)(
l)
and
46.306(
a)(
2)
for
certain
research
conducted
or
supported
by
DHHS
that
involves
epidemiologic
studies
that
meet
the
following
criteria:
(
1)
In
which
the
sole
purposes
are
(
i)
To
describe
the
prevalence
or
incidence
of
a
disease
by
identifying
all
cases,
or
(
ii)
To
study
potential
risk
factor
associations
for
a
disease,
and
(
2)
Where
the
institution
responsible
for
the
conduct
of
the
research
certifies
to
the
Office
for
Human
Research
Protections,
DHHS,
acting
on
behalf
of
VerDate
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19,
2003
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