[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); http://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); 
http://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; 
http://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.


[[Page 73156]]


0
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]
 BILLING CODE 4410-05-P