Infectious Disease Management: Voluntary and Involuntary Testing, 73153-73156 [2015-29790]
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Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Proposed Rules
current, is non-controversial and
unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a
‘‘significant regulatory action’’ under
Executive Order 12866; (2) is not a
‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that will only affect air
traffic procedures and air navigation, it
is certified that this rule, when
promulgated, would not have a
significant economic impact on a
substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
Environmental Review
This proposal will be subject to an
environmental analysis in accordance
with FAA Order 1050.1F,
‘‘Environmental Impacts: Policies and
Procedures’’ prior to any FAA final
regulatory action.
Authority: 49 U.S.C. 106(f), 106(g), 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.9Z,
Airspace Designations and Reporting
Points, dated August 6, 2015, and
effective September 15, 2015, is
amended as follows:
■
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
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*
ANM WA E5 Willapa Harbor Heliport,
South Bend, WA [New]
Willapa Harbor Heliport, WA
(Lat. 46°39′47″ N., long. 123°48′44″ W.)
That airspace extending upward from 700
feet above the surface within a 1.8-mile
radius of Willapa Harbor Heliport, and that
airspace bounded by a line beginning at a
point where the Willapa Harbor 278° bearing
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BILLING CODE 4164–01–P
[FR Doc. 2015–29832 Filed 11–23–15; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF JUSTICE
Bureau of Prisons
28 CFR Part 549
[BOP–1169–P]
RIN 1120–AB69
BASF Corp.; Filing of Food Additive
Petition (Animal Use)
Infectious Disease Management:
Voluntary and Involuntary Testing
AGENCY:
Food and Drug Administration,
HHS.
Notice of petition.
The Food and Drug
Administration (FDA) is announcing
that BASF Corp. has filed a petition
proposing that the food additive
regulations be amended to provide for
the safe use of sodium formate as a feed
acidifier in poultry feed.
DATES: The food additive petition was
filed on October 15, 2015.
FOR FURTHER INFORMATION CONTACT:
Chelsea Trull, Center for Veterinary
Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–6729,
chelsea.trull@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
Federal Food, Drug, and Cosmetic Act
(section 409(b)(5) (21 U.S.C. 348(b)(5))),
notice is given that a food additive
petition (FAP 2293) has been filed by
BASF Corp., 100 Park Ave., Florham
Park, NJ 07932. The petition proposes to
amend the food additive regulations in
21 CFR part 573 Food Additives
Permitted in Feed and Drinking Water of
Animals to provide for the safe use of
sodium formate as a feed acidifier in
poultry feed.
The petitioner has claimed that this
action is categorically excluded under
21 CFR 25.32(r) because it is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. In addition,
the petitioner has stated that to their
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Bureau of Prisons, Justice.
Proposed rule.
AGENCY:
ACTION:
SUMMARY:
1. The authority citation for 14 CFR
part 71 continues to read as follows:
*
[FR Doc. 2015–29788 Filed 11–23–15; 8:45 am]
ACTION:
■
*
Dated: November 18, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[Docket No. FDA–2015–F–4282]
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
*
Issued in Seattle, Washington, on
November 10, 2015.
Christopher Ramirez,
Manager, Operations Support Group, Western
Service Center.
21 CFR Part 573
The Proposed Amendment
Accordingly, pursuant to the
authority delegated to me, the Federal
Aviation Administration proposes to
amend 14 CFR part 71 as follows:
*
knowledge, no extraordinary
circumstances exist. If FDA determines
a categorical exclusion applies, neither
an environmental assessment nor an
environmental impact statement is
required. If FDA determines a
categorical exclusion does not apply, we
will request an environmental
assessment and make it available for
public inspection.
Food and Drug Administration
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
§ 71.1
intersects the Willapa Harbor 1.8-mile radius,
thence northwest to lat. 46°42′26″ N., long.
123°55′39″ W.; to lat. 46°45′28″ N., long.
123°52′46″ W.; to lat. 46°43′55″ N., long.
123°48′46″ W.; to lat. 46°41′18″ N., long.
123°46′14″ W.; to a point where the Willapa
Harbor 98° bearing intersects the Willapa
Harbor 1.8-mile radius, thence clockwise
along the 1.8-mile radius to the point of
beginning.
73153
In this document, the Bureau
of Prisons proposes two minor revisions
to its regulations on the management of
infectious diseases. One change would
remove the requirement for HIV pre-test
counseling for inmates, because the
counseling requirement has become an
obstacle to necessary testing. Inmates
testing positive for HIV will continue to
receive HIV post-test counseling. The
second change would alter language
regarding tuberculosis (TB) testing to
clarify that it is testing for the TB
infection, but not ‘‘skin testing.’’ This
would account for advances in medical
technology that allow for newer testing
methods.
DATES: Written comments must be
submitted on or before January 25, 2016.
ADDRESSES: Rules Unit, Office of
General Counsel, Bureau of Prisons, 320
First Street NW., Washington, DC
20534.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Rules Unit, Office of General Counsel,
Bureau of Prisons, phone (202) 353–
8214.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments
received are considered part of the
public record and made available for
public inspection online at
www.regulations.gov. Such information
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Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Proposed Rules
includes personal identifying
information (such as your name,
address, etc.) voluntarily submitted by
the commenter.
If you want to submit personal
identifying information (such as your
name, address, etc.) as part of your
comment, but do not want it to be
posted online, you must include the
phrase ‘‘PERSONAL IDENTIFYING
INFORMATION’’ in the first paragraph
of your comment. You must also locate
all the personal identifying information
you do not want posted online in the
first paragraph of your comment and
identify what information you want
redacted.
If you want to submit confidential
business information as part of your
comment but do not want it to be posted
online, you must include the phrase
‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify confidential
business information to be redacted
within the comment. If a comment
contains so much confidential business
information that it cannot be effectively
redacted, all or part of that comment
may not be posted on
www.regulations.gov.
Personal identifying information
identified and located as set forth above
will be placed in the agency’s public
docket file, but not posted online.
Confidential business information
identified and located as set forth above
will not be placed in the public docket
file. If you wish to inspect the agency’s
public docket file in person by
appointment, please see the ‘‘For
Further Information Contact’’ paragraph.
SUPPLEMENTARY INFORMATION: The
Bureau proposes two minor revisions to
its regulations on the infectious disease
management program (28 CFR, part 549,
subpart A). One change would remove
the requirement for HIV pre-test
counseling for inmates, because the
counseling requirement has become an
obstacle to necessary testing. Inmates
testing positive for HIV will continue to
receive HIV post-test counseling. The
second change would alter language
regarding tuberculosis (TB) testing to
clarify that it is testing for the TB
infection, but not ‘‘skin testing.’’ This
would account for advances in medical
technology that allow for newer testing
methods.
Clarifications to inmate information
procedures. 28 CFR 549.12(a)(1)
currently states that the ‘‘Bureau tests
inmates who have sentences of six
months or more if health services staff
determine, taking into consideration the
risk as defined by the Centers for
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Disease Control Guidelines, that the
inmate is at risk for HIV infection.’’ We
propose to make minor clarifying
changes to this language to make it clear
that such inmates will be informed
orally or in writing that HIV testing will
be performed unless they decline
testing. This would be a minor change
to be consistent with CDC Guidelines,
which state that ‘‘HIV screening is
recommended for patients in all healthcare settings after the patient is notified
that testing will be performed unless the
patient declines (opt-out screening)’’. In
light of the CDC Guidelines, we propose
to change the regulation language to
clarify that HIV screening is
recommended for all inmates because
risk factors are present in the
correctional health-care setting. The
language as it currently exists in the
regulation does not make it clear that
inmates will be so notified, although
this has already been the Bureau’s
longstanding procedure during
Admission and Orientation of inmates.
Eliminating the requirement for HIV
pre-test counseling and HIV post-test
counseling for HIV-negative inmates. In
28 CFR 549.12 (Testing), subparagraph
(a)(5) currently states that ‘‘Inmates
being tested for HIV will receive preand post-test counseling, regardless of
the test results.’’ We propose altering
this subparagraph to read as follows:
‘‘Inmates testing positive for HIV will
receive post-test counseling.’’ This
change would eliminate the requirement
that the Bureau provide pre-test
counseling for inmates and post-test
counseling for HIV-negative inmates.
We propose these changes to bring our
requirements in conformance with those
recommended by the Center for Disease
Control (CDC) in their report entitled
‘‘Revised Recommendations for HIV
Testing of Adults, Adolescents, and
Pregnant Women in Health Care
Settings’’ (2006, MMWR 55(RR14); 1–
17); https://www.cdc.gov/mmwr/preview/
mmwrhtml/rr5514a1.htm.
The CDC set forth guidelines in 1994
for counseling and testing persons with
high-risk behaviors which specified
prevention (pre-test) counseling to
develop specific prevention goals and
strategies for each person (clientcentered counseling). However, in 2003,
CDC introduced an initiative entitled
‘‘Advancing HIV Prevention: New
Strategies for a Changing Epidemic’’.
One key point of this initiative was to
make HIV testing a routine part of
medical care on the same voluntary
basis as other diagnostic and screening
tests. In its technical guidance, CDC
acknowledged that although prevention
(pre-test) counseling is desirable for all
persons at risk for HIV, such counseling
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might not be appropriate or feasible in
all settings. Because time constraints
caused some providers to perceive
requirements for prevention counseling
and written informed consent as a
barrier to uniform testing, the initiative
advocated streamlined approaches. The
CDC found that although targeted
testing programs, like the Bureau’s
infection disease management program,
were implemented in acute-care settings
and nearly two thirds of patients in
these settings accept testing; risk
assessment and prevention (pre-test)
counseling are time-consuming, so only
a limited proportion of eligible patients
can be tested.
There are significant benefits of HIV
testing for inmates because treatment for
HIV can be initiated promptly
preventing serious complications and
death. The CDC has found that
requirements for pre-test prevention
counseling pose a barrier to testing and
therefore CDC recommends that an
‘‘opt-out’’ testing protocol be utilized, in
which persons are informed that they
will be tested unless they choose not to
be tested. Specifically CDC recommends
that:
• HIV screening is recommended for
patients in all health-care settings after
the patient is notified that testing will
be performed unless the patient declines
(opt-out screening).
• Separate written consent for HIV
testing should not be required; general
consent for medical care should be
considered sufficient to encompass
consent for HIV testing.
• Prevention counseling should not
be required with HIV diagnostic testing
or as part of HIV screening programs in
health-care settings.
‘‘Revised Recommendations for HIV
Testing of Adults, Adolescents, and
Pregnant Women in Health Care
Settings’’ (2006, MMWR 55(RR14); 1–
17); https://www.cdc.gov/mmwr/preview/
mmwrhtml/rr5514a1.htm.
In addition to the above, the Bureau
also notes that eliminating the pre-test
counseling requirement would save
Bureau staff approximately 20 minutes
per counseling session. Since the
Bureau strives to test all inmates, the
time savings this would permit are
substantial. We therefore propose to
delete the requirement for pre-test
counseling in order to conform with
CDC guidelines and to remove this
barrier to testing as many inmates as
possible.
We also propose to remove the
requirement for post-HIV-test
counseling for inmates who have tested
negative for HIV. Those testing positive
will continue to receive post-test
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counseling. Those testing negative,
however, have no need for further
counseling, but may ask questions of
Health Services staff as needed.
Eliminating the post-test counseling
requirement for inmates testing HIV
negative would also save 20 minutes per
counseling session per inmate. Again,
the time saving is quite substantial,
considering that more than 98% of HIV
tests performed are negative results.
Changing terminology to clarify that
TB testing is no longer ‘‘skin testing.’’ In
28 CFR 549.12(b)(4), we currently state
that ‘‘[i]f an inmate refuses skin testing,
and there is no contraindication to
tuberculin skin testing, then, institution
medical staff will test the inmate
involuntarily.’’ (Emphasis added.) We
now proposed to alter this sentence to
read as follows: ‘‘If an inmate refuses
testing for TB infection, and there is no
contraindication to testing, then
institutional medical staff will test the
inmate involuntarily.’’ The only
alteration we make in this language is to
clarify that Tuberculosis testing is no
longer ‘‘skin testing.’’
The Bureau currently primarily uses
the tuberculin skin test for testing for
latent TB infection. However, a new
type of test for TB infection has become
available, a blood test called the
Interferon Gamma Release Assay
(IGRA). In the next 5 to 10 years it is
anticipated that blood tests for TB
infection will replace the tuberculin
skin test. These tests appear to be at
least as accurate as the skin test and
have the benefit of requiring only one
interaction with an inmate to draw
blood (rather than place the skin test
and reading it 2 to 3 days later). Using
this type of test would eliminate the
need for a second health care visit to
conduct the test, as no ‘‘reading’’ would
be required, which would result in great
time savings to Bureau staff.
Once more, we make this change to
bring the Bureau into conformance with
CDC guidelines. In 2010, the CDC issued
‘‘Updated Guidelines for Using
Interferon Gamma Release Assays to
Detect Mycobacterium tuberculosis
infection—United States, 2010’’
(MMWR 59(RR–5) 1–13; https://www.
cdc.gov/mmwr/pdf/rr/rr5905.pdf. In this
report, the CDC states that ‘‘[b]efore
2001, the tuberculin skin test (TST) was
the only practical and commercially
available immunologic test for TB
infection approved in the United
States.’’
However, several risks are associated
with the use of TSTs: Difficulty with the
very specific administration needed,
unreliable patient return to the healthcare provider for the test reading, and
inaccuracies and biases existing in
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reading the TSTs, such as falsepositives. IGRAs, however, assess the
presence of specific tuberculosis
proteins, and therefore offer improved
test specificity compared with TSTs.
For this reason, the CDC has
recommended increasing use of IGRAs.
Although skin testing may still be used,
it will not be used exclusively, so we
propose to update our regulatory
language to allow for the possibility of
other kinds of testing for TB infection.
Other changes for clarity:
We also propose to make minor
changes to § 549.12(a)(2), Exposure
incidents, to clarify that the current
language stating that the Bureau will
test ‘‘when there is a well-founded
reason to believe that the inmate may
have transmitted the HIV infection’’
means the following: The Bureau tests
an inmate, regardless of the length of
sentence or pretrial status, when there is
a well-founded reason to believe that
the inmate has been the source of a
percutaneous or mucous membrane
blood exposure, via an altercation or
accident or other means to Bureau
employees, other non-inmates who are
lawfully present in a Bureau institution,
or other inmates, regardless of whether
the exposure was intentional or
unintentional. Exposure incident testing
does not require the inmate’s consent.
This language more accurately reflects
the intention of the regulation.
Executive Order 12866
This proposed regulation has been
drafted and reviewed in accordance
with Executive Order 12866,
‘‘Regulatory Planning and Review’’,
section 1(b), Principles of Regulation.
The Director, Bureau of Prisons has
determined that this proposed
regulation is a ‘‘significant regulatory
action’’ under Executive Order 12866,
section 3(f), and accordingly this
proposed regulation has been reviewed
by the Office of Management and
Budget.
Executive Order 13132
This proposed regulation will not
have substantial direct effects on the
States, on the relationship between the
national government and the States, or
on distribution of power and
responsibilities among the various
levels of government. Therefore, under
Executive Order 13132, we determine
that this proposed regulation does not
have sufficient federalism implications
to warrant the preparation of a
Federalism Assessment.
Regulatory Flexibility Act
The Director of the Bureau of Prisons,
under the Regulatory Flexibility Act (5
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73155
U.S.C. 605(b)), reviewed this proposed
regulation and certifies that it will not
have a significant economic impact
upon a substantial number of small
entities for the following reasons: This
proposed regulation pertains to the
correctional management of inmates
committed to the custody of the
Attorney General or the Director of the
Bureau of Prisons. Its economic impact
is limited to the Bureau’s appropriated
funds.
Unfunded Mandates Reform Act of
1995
This proposed regulation will not
result in the expenditure by State, local
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more in any one year, and it will not
significantly or uniquely affect small
governments. Therefore, no actions were
deemed necessary under the provisions
of the Unfunded Mandates Reform Act
of 1995.
Small Business Regulatory Enforcement
Fairness Act of 1996
This proposed rule is not a major rule
as defined by section 251 of the Small
Business Regulatory Enforcement
Fairness Act of 1996, 5 U.S.C. 804. This
proposed regulation will not result in an
annual effect on the economy of
$100,000,000 or more; a major increase
in costs or prices; or significant adverse
effects on competition, employment,
investment, productivity, innovation, or
on the ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
List of Subjects in 28 CFR Part 571
Prisoners.
Charles E. Samuels, Jr.,
Director, Bureau of Prisons.
Under rulemaking authority vested in
the Attorney General in 5 U.S.C. 301; 28
U.S.C. 509, 510 and delegated to the
Director, Bureau of Prisons in 28 CFR
0.96, we proposed to amend 28 CFR part
549 as follows.
SUBCHAPTER C—INSTITUTIONAL
MANAGEMENT
PART 549—MEDICAL SERVICES
1. The authority citation for 28 CFR
part 549 continues to read as follows:
■
Authority: 5 U.S.C. 301; 10 U.S.C. 876b; 18
U.S.C. 3621, 3622, 3524, 4001, 4005, 4042,
4045, 4081, 4082 (Repealed in part as to
offenses committed on or after November 1,
1987), Chapter 313, 5006–5024 (Repealed
October 12, 1984 as to offenses committed
after that date), 5039; 28 U.S.C. 509, 510.
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2. Amend § 549.12 by revising
paragraphs (a) and (b)(4) to read as
follows:
■
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§ 549.12
[Docket No. USCG–2013–0760]
and Automatic Identification System.
This rule contains an exemption, at 33
CFR 160.204(a)(3), for any vessel
required to report its movements, its
cargo, or the cargo in barges it is towing
under 33 CFR 165.830 after December
31, 2015.
RIN 1625–AA11
II. Discussion
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
Testing.
(a) Human Immunodeficiency Virus
(HIV)—(1) Testing. All inmates who
have sentences of six months or more
will be informed upon admission either
orally or in writing that HIV testing will
be performed unless they refuse testing.
If the inmate refuses testing and the
inmate has risk factors for HIV infection
as defined by the Centers for Disease
Control and Prevention, staff will
provide pre-test counseling, and if the
inmate continues to refuse testing, staff
may initiate an incident report for
refusing to obey an order. Any inmate
may request HIV testing during the prerelease process.
(2) Exposure incidents. The Bureau
tests an inmate, regardless of the length
of sentence or pretrial status, when
there is a well-founded reason to believe
that the inmate has been the source of
a percutaneous or mucous membrane
blood exposure, via an altercation or
accident or other means to Bureau
employees, other non-inmates who are
lawfully present in a Bureau institution,
or other inmates, regardless of whether
the exposure was intentional or
unintentional. Exposure incident testing
does not require the inmate’s consent.
(3) Surveillance testing. The Bureau
conducts HIV testing for surveillance
purposes as needed. If the inmate
refuses testing, staff will offer pre-test
counseling, and if the inmate continues
to refuse testing, staff may initiate an
incident report for refusing to obey an
order.
(4) Inmate request. An inmate may
request to be tested. The Bureau limits
such testing to no more than one per 12month period unless the Bureau
determines that additional testing is
warranted.
(5) Counseling. Inmates testing
positive for HIV will receive post-test
counseling.
(b) * * *
*
*
*
*
*
(4) An inmate who refuses TB
screening may be subject to an incident
report for refusing to obey an order. If
an inmate refuses testing for TB
infection, and there is no
contraindication to testing, then,
institution medical staff will test the
inmate involuntarily.
[FR Doc. 2015–29790 Filed 11–23–15; 8:45 am]
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33 CFR Part 165
Regulated Navigation Area; Reporting
Requirements for Barges Loaded With
Certain Dangerous Cargoes, Inland
Rivers, Eighth Coast Guard District;
Stay (Suspension) Expiring
Coast Guard, DHS.
Notice of intent.
AGENCY:
ACTION:
The stay of reporting
requirements under the Regulated
Navigation Area (RNA) applicable to
barges loaded with certain dangerous
cargoes on the inland rivers in the
Eighth District area of responsibility
(AOR) is scheduled to expire on
December 31, 2015. The Coast Guard
intends to allow the stay to expire in
part. Once the stay partially expires,
RNA reporting requirements in a limited
form will resume under the existing
regulation. The Coast Guard is
developing an amendment to the
existing regulation.
DATES: November 24, 2015.
FOR FURTHER INFORMATION CONTACT: For
information about this document call or
email Shelley Miller, Coast Guard;
telephone 504–671–2330, email
Shelley.R.Miller@uscg.mil.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background and Regulatory History
The reporting requirements under 33
CFR 165.830, ‘‘Regulated Navigation
Area; Reporting Requirements for Barges
Loaded with Certain Dangerous Cargoes,
Inland Rivers, Eighth Coast Guard
District,’’ were initially suspended in
January 2011 due to the expiration of
the contract for the reporting system at
the Inland River Vessel Movement
Center (IRVMC). This suspension was
published in the Federal Register on
January 10, 2011 and was due to expire
on January 15, 2013 (76 FR 1360). On
January 2, 2013, the Coast Guard
extended this suspension through
September 30, 2013 (78 FR 25) and on
October 1, 2013, the Coast Guard
extended the suspension again through
December 31, 2015 (78 FR 60216). The
suspension of reporting requirements is
scheduled to expire on December 31,
2015.
Additionally, the Coast Guard
published a final rule in January 2015
(80 FR 5282), titled Vessel Requirements
for Notices of Arrival and Departure,
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The Coast Guard intends to allow the
suspension of certain reporting
requirements under 33 CFR 165.830 to
expire as scheduled. The Coast Guard
does not intend to reinstate reporting,
24 hours per day, 365 days per year, at
90 plus reporting points under the RNA
as currently published. Rather, we
anticipate reporting will be required in
response to specific concerns, under a
limited form of the RNA currently in the
CFR.
Specifically, the Coast Guard is
considering whether existing
§ 165.830(d)(1)(ix), (d)(2)(iv), (f)(9),
(g)(4), and (h) of the existing RNA may
take effect on January 1, 2016, with
revisions to the references to IRVMC.
Although we have not yet developed
revisions to the existing regulation, we
are publishing this document to inform
members of the public who are aware of,
and may have questions about, the
upcoming expiration of the suspension.
This document is issued under
authority of 5 U.S.C. 552(a).
Dated: November 9, 2015.
D.R. Callahan,
Rear Admiral, U.S. Coast Guard, Commander,
Eighth Coast Guard District.
[FR Doc. 2015–29714 Filed 11–23–15; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R09–OAR–2015–0545; FRL–9937–27–
Region 9]
Disapproval of California Air Plan
Revisions, South Coast Air Quality
Management District
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to
disapprove revisions to the South Coast
Air Quality Management District
(SCAQMD) portion of the California
State Implementation Plan (SIP)
concerning Vehicle Scrapping,
Employee Trip Reduction, and
procedures for the hearing board
concerning variances and subpoenas.
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 226 (Tuesday, November 24, 2015)]
[Proposed Rules]
[Pages 73153-73156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29790]
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DEPARTMENT OF JUSTICE
Bureau of Prisons
28 CFR Part 549
[BOP-1169-P]
RIN 1120-AB69
Infectious Disease Management: Voluntary and Involuntary Testing
AGENCY: Bureau of Prisons, Justice.
ACTION: Proposed rule.
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SUMMARY: In this document, the Bureau of Prisons proposes two minor
revisions to its regulations on the management of infectious diseases.
One change would remove the requirement for HIV pre-test counseling for
inmates, because the counseling requirement has become an obstacle to
necessary testing. Inmates testing positive for HIV will continue to
receive HIV post-test counseling. The second change would alter
language regarding tuberculosis (TB) testing to clarify that it is
testing for the TB infection, but not ``skin testing.'' This would
account for advances in medical technology that allow for newer testing
methods.
DATES: Written comments must be submitted on or before January 25,
2016.
ADDRESSES: Rules Unit, Office of General Counsel, Bureau of Prisons,
320 First Street NW., Washington, DC 20534.
FOR FURTHER INFORMATION CONTACT: Rules Unit, Office of General Counsel,
Bureau of Prisons, phone (202) 353-8214.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received are considered part of the
public record and made available for public inspection online at
www.regulations.gov. Such information
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includes personal identifying information (such as your name, address,
etc.) voluntarily submitted by the commenter.
If you want to submit personal identifying information (such as
your name, address, etc.) as part of your comment, but do not want it
to be posted online, you must include the phrase ``PERSONAL IDENTIFYING
INFORMATION'' in the first paragraph of your comment. You must also
locate all the personal identifying information you do not want posted
online in the first paragraph of your comment and identify what
information you want redacted.
If you want to submit confidential business information as part of
your comment but do not want it to be posted online, you must include
the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the first paragraph
of your comment. You must also prominently identify confidential
business information to be redacted within the comment. If a comment
contains so much confidential business information that it cannot be
effectively redacted, all or part of that comment may not be posted on
www.regulations.gov.
Personal identifying information identified and located as set
forth above will be placed in the agency's public docket file, but not
posted online. Confidential business information identified and located
as set forth above will not be placed in the public docket file. If you
wish to inspect the agency's public docket file in person by
appointment, please see the ``For Further Information Contact''
paragraph.
SUPPLEMENTARY INFORMATION: The Bureau proposes two minor revisions to
its regulations on the infectious disease management program (28 CFR,
part 549, subpart A). One change would remove the requirement for HIV
pre-test counseling for inmates, because the counseling requirement has
become an obstacle to necessary testing. Inmates testing positive for
HIV will continue to receive HIV post-test counseling. The second
change would alter language regarding tuberculosis (TB) testing to
clarify that it is testing for the TB infection, but not ``skin
testing.'' This would account for advances in medical technology that
allow for newer testing methods.
Clarifications to inmate information procedures. 28 CFR
549.12(a)(1) currently states that the ``Bureau tests inmates who have
sentences of six months or more if health services staff determine,
taking into consideration the risk as defined by the Centers for
Disease Control Guidelines, that the inmate is at risk for HIV
infection.'' We propose to make minor clarifying changes to this
language to make it clear that such inmates will be informed orally or
in writing that HIV testing will be performed unless they decline
testing. This would be a minor change to be consistent with CDC
Guidelines, which state that ``HIV screening is recommended for
patients in all health-care settings after the patient is notified that
testing will be performed unless the patient declines (opt-out
screening)''. In light of the CDC Guidelines, we propose to change the
regulation language to clarify that HIV screening is recommended for
all inmates because risk factors are present in the correctional
health-care setting. The language as it currently exists in the
regulation does not make it clear that inmates will be so notified,
although this has already been the Bureau's longstanding procedure
during Admission and Orientation of inmates.
Eliminating the requirement for HIV pre-test counseling and HIV
post-test counseling for HIV-negative inmates. In 28 CFR 549.12
(Testing), subparagraph (a)(5) currently states that ``Inmates being
tested for HIV will receive pre- and post-test counseling, regardless
of the test results.'' We propose altering this subparagraph to read as
follows: ``Inmates testing positive for HIV will receive post-test
counseling.'' This change would eliminate the requirement that the
Bureau provide pre-test counseling for inmates and post-test counseling
for HIV-negative inmates. We propose these changes to bring our
requirements in conformance with those recommended by the Center for
Disease Control (CDC) in their report entitled ``Revised
Recommendations for HIV Testing of Adults, Adolescents, and Pregnant
Women in Health Care Settings'' (2006, MMWR 55(RR14); 1-17); https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm.
The CDC set forth guidelines in 1994 for counseling and testing
persons with high-risk behaviors which specified prevention (pre-test)
counseling to develop specific prevention goals and strategies for each
person (client-centered counseling). However, in 2003, CDC introduced
an initiative entitled ``Advancing HIV Prevention: New Strategies for a
Changing Epidemic''. One key point of this initiative was to make HIV
testing a routine part of medical care on the same voluntary basis as
other diagnostic and screening tests. In its technical guidance, CDC
acknowledged that although prevention (pre-test) counseling is
desirable for all persons at risk for HIV, such counseling might not be
appropriate or feasible in all settings. Because time constraints
caused some providers to perceive requirements for prevention
counseling and written informed consent as a barrier to uniform
testing, the initiative advocated streamlined approaches. The CDC found
that although targeted testing programs, like the Bureau's infection
disease management program, were implemented in acute-care settings and
nearly two thirds of patients in these settings accept testing; risk
assessment and prevention (pre-test) counseling are time-consuming, so
only a limited proportion of eligible patients can be tested.
There are significant benefits of HIV testing for inmates because
treatment for HIV can be initiated promptly preventing serious
complications and death. The CDC has found that requirements for pre-
test prevention counseling pose a barrier to testing and therefore CDC
recommends that an ``opt-out'' testing protocol be utilized, in which
persons are informed that they will be tested unless they choose not to
be tested. Specifically CDC recommends that:
HIV screening is recommended for patients in all health-
care settings after the patient is notified that testing will be
performed unless the patient declines (opt-out screening).
Separate written consent for HIV testing should not be
required; general consent for medical care should be considered
sufficient to encompass consent for HIV testing.
Prevention counseling should not be required with HIV
diagnostic testing or as part of HIV screening programs in health-care
settings.
``Revised Recommendations for HIV Testing of Adults, Adolescents, and
Pregnant Women in Health Care Settings'' (2006, MMWR 55(RR14); 1-17);
https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm.
In addition to the above, the Bureau also notes that eliminating
the pre-test counseling requirement would save Bureau staff
approximately 20 minutes per counseling session. Since the Bureau
strives to test all inmates, the time savings this would permit are
substantial. We therefore propose to delete the requirement for pre-
test counseling in order to conform with CDC guidelines and to remove
this barrier to testing as many inmates as possible.
We also propose to remove the requirement for post-HIV-test
counseling for inmates who have tested negative for HIV. Those testing
positive will continue to receive post-test
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counseling. Those testing negative, however, have no need for further
counseling, but may ask questions of Health Services staff as needed.
Eliminating the post-test counseling requirement for inmates testing
HIV negative would also save 20 minutes per counseling session per
inmate. Again, the time saving is quite substantial, considering that
more than 98% of HIV tests performed are negative results.
Changing terminology to clarify that TB testing is no longer ``skin
testing.'' In 28 CFR 549.12(b)(4), we currently state that ``[i]f an
inmate refuses skin testing, and there is no contraindication to
tuberculin skin testing, then, institution medical staff will test the
inmate involuntarily.'' (Emphasis added.) We now proposed to alter this
sentence to read as follows: ``If an inmate refuses testing for TB
infection, and there is no contraindication to testing, then
institutional medical staff will test the inmate involuntarily.'' The
only alteration we make in this language is to clarify that
Tuberculosis testing is no longer ``skin testing.''
The Bureau currently primarily uses the tuberculin skin test for
testing for latent TB infection. However, a new type of test for TB
infection has become available, a blood test called the Interferon
Gamma Release Assay (IGRA). In the next 5 to 10 years it is anticipated
that blood tests for TB infection will replace the tuberculin skin
test. These tests appear to be at least as accurate as the skin test
and have the benefit of requiring only one interaction with an inmate
to draw blood (rather than place the skin test and reading it 2 to 3
days later). Using this type of test would eliminate the need for a
second health care visit to conduct the test, as no ``reading'' would
be required, which would result in great time savings to Bureau staff.
Once more, we make this change to bring the Bureau into conformance
with CDC guidelines. In 2010, the CDC issued ``Updated Guidelines for
Using Interferon Gamma Release Assays to Detect Mycobacterium
tuberculosis infection--United States, 2010'' (MMWR 59(RR-5) 1-13;
https://www.cdc.gov/mmwr/pdf/rr/rr5905.pdf. In this report, the CDC
states that ``[b]efore 2001, the tuberculin skin test (TST) was the
only practical and commercially available immunologic test for TB
infection approved in the United States.''
However, several risks are associated with the use of TSTs:
Difficulty with the very specific administration needed, unreliable
patient return to the health-care provider for the test reading, and
inaccuracies and biases existing in reading the TSTs, such as false-
positives. IGRAs, however, assess the presence of specific tuberculosis
proteins, and therefore offer improved test specificity compared with
TSTs.
For this reason, the CDC has recommended increasing use of IGRAs.
Although skin testing may still be used, it will not be used
exclusively, so we propose to update our regulatory language to allow
for the possibility of other kinds of testing for TB infection.
Other changes for clarity:
We also propose to make minor changes to Sec. 549.12(a)(2),
Exposure incidents, to clarify that the current language stating that
the Bureau will test ``when there is a well-founded reason to believe
that the inmate may have transmitted the HIV infection'' means the
following: The Bureau tests an inmate, regardless of the length of
sentence or pretrial status, when there is a well-founded reason to
believe that the inmate has been the source of a percutaneous or mucous
membrane blood exposure, via an altercation or accident or other means
to Bureau employees, other non-inmates who are lawfully present in a
Bureau institution, or other inmates, regardless of whether the
exposure was intentional or unintentional. Exposure incident testing
does not require the inmate's consent. This language more accurately
reflects the intention of the regulation.
Executive Order 12866
This proposed regulation has been drafted and reviewed in
accordance with Executive Order 12866, ``Regulatory Planning and
Review'', section 1(b), Principles of Regulation. The Director, Bureau
of Prisons has determined that this proposed regulation is a
``significant regulatory action'' under Executive Order 12866, section
3(f), and accordingly this proposed regulation has been reviewed by the
Office of Management and Budget.
Executive Order 13132
This proposed regulation will not have substantial direct effects
on the States, on the relationship between the national government and
the States, or on distribution of power and responsibilities among the
various levels of government. Therefore, under Executive Order 13132,
we determine that this proposed regulation does not have sufficient
federalism implications to warrant the preparation of a Federalism
Assessment.
Regulatory Flexibility Act
The Director of the Bureau of Prisons, under the Regulatory
Flexibility Act (5 U.S.C. 605(b)), reviewed this proposed regulation
and certifies that it will not have a significant economic impact upon
a substantial number of small entities for the following reasons: This
proposed regulation pertains to the correctional management of inmates
committed to the custody of the Attorney General or the Director of the
Bureau of Prisons. Its economic impact is limited to the Bureau's
appropriated funds.
Unfunded Mandates Reform Act of 1995
This proposed regulation will not result in the expenditure by
State, local and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more in any one year, and it will
not significantly or uniquely affect small governments. Therefore, no
actions were deemed necessary under the provisions of the Unfunded
Mandates Reform Act of 1995.
Small Business Regulatory Enforcement Fairness Act of 1996
This proposed rule is not a major rule as defined by section 251 of
the Small Business Regulatory Enforcement Fairness Act of 1996, 5
U.S.C. 804. This proposed regulation will not result in an annual
effect on the economy of $100,000,000 or more; a major increase in
costs or prices; or significant adverse effects on competition,
employment, investment, productivity, innovation, or on the ability of
United States-based companies to compete with foreign-based companies
in domestic and export markets.
List of Subjects in 28 CFR Part 571
Prisoners.
Charles E. Samuels, Jr.,
Director, Bureau of Prisons.
Under rulemaking authority vested in the Attorney General in 5
U.S.C. 301; 28 U.S.C. 509, 510 and delegated to the Director, Bureau of
Prisons in 28 CFR 0.96, we proposed to amend 28 CFR part 549 as
follows.
SUBCHAPTER C--INSTITUTIONAL MANAGEMENT
PART 549--MEDICAL SERVICES
0
1. The authority citation for 28 CFR part 549 continues to read as
follows:
Authority: 5 U.S.C. 301; 10 U.S.C. 876b; 18 U.S.C. 3621, 3622,
3524, 4001, 4005, 4042, 4045, 4081, 4082 (Repealed in part as to
offenses committed on or after November 1, 1987), Chapter 313, 5006-
5024 (Repealed October 12, 1984 as to offenses committed after that
date), 5039; 28 U.S.C. 509, 510.
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2. Amend Sec. 549.12 by revising paragraphs (a) and (b)(4) to read as
follows:
Sec. 549.12 Testing.
(a) Human Immunodeficiency Virus (HIV)--(1) Testing. All inmates
who have sentences of six months or more will be informed upon
admission either orally or in writing that HIV testing will be
performed unless they refuse testing. If the inmate refuses testing and
the inmate has risk factors for HIV infection as defined by the Centers
for Disease Control and Prevention, staff will provide pre-test
counseling, and if the inmate continues to refuse testing, staff may
initiate an incident report for refusing to obey an order. Any inmate
may request HIV testing during the pre-release process.
(2) Exposure incidents. The Bureau tests an inmate, regardless of
the length of sentence or pretrial status, when there is a well-founded
reason to believe that the inmate has been the source of a percutaneous
or mucous membrane blood exposure, via an altercation or accident or
other means to Bureau employees, other non-inmates who are lawfully
present in a Bureau institution, or other inmates, regardless of
whether the exposure was intentional or unintentional. Exposure
incident testing does not require the inmate's consent.
(3) Surveillance testing. The Bureau conducts HIV testing for
surveillance purposes as needed. If the inmate refuses testing, staff
will offer pre-test counseling, and if the inmate continues to refuse
testing, staff may initiate an incident report for refusing to obey an
order.
(4) Inmate request. An inmate may request to be tested. The Bureau
limits such testing to no more than one per 12-month period unless the
Bureau determines that additional testing is warranted.
(5) Counseling. Inmates testing positive for HIV will receive post-
test counseling.
(b) * * *
* * * * *
(4) An inmate who refuses TB screening may be subject to an
incident report for refusing to obey an order. If an inmate refuses
testing for TB infection, and there is no contraindication to testing,
then, institution medical staff will test the inmate involuntarily.
[FR Doc. 2015-29790 Filed 11-23-15; 8:45 am]
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