80_FR_12148 80 FR 12104 - Determination That an Individual Shall Not Be Deemed an Employee of the Public Health Service

80 FR 12104 - Determination That an Individual Shall Not Be Deemed an Employee of the Public Health Service

DEPARTMENT OF JUSTICE

Federal Register Volume 80, Issue 44 (March 6, 2015)

Page Range12104-12109
FR Document2015-05027

The proposed rule proposes criteria and a process by which the Attorney General or designee may determine that an individual shall not be deemed an employee of the Public Health Service for purposes of coverage under the Federal Tort Claims Act.

Federal Register, Volume 80 Issue 44 (Friday, March 6, 2015)
[Federal Register Volume 80, Number 44 (Friday, March 6, 2015)]
[Proposed Rules]
[Pages 12104-12109]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-05027]


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DEPARTMENT OF JUSTICE

28 CFR Part 15

[Docket No. CIV 150; AG Order No. 3504-2015]
RIN 1105-AB37


Determination That an Individual Shall Not Be Deemed an Employee 
of the Public Health Service

AGENCY: Department of Justice.

ACTION: Proposed rule.

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SUMMARY: The proposed rule proposes criteria and a process by which the 
Attorney General or designee may determine that an individual shall not 
be deemed an employee of the Public Health Service for purposes of 
coverage under the Federal Tort Claims Act.

DATES: Written comments must be postmarked on or before May 5, 2015, 
and electronic comments must be sent on or before midnight Eastern time 
May 5, 2015.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. CIV 150'' on all written and electronic correspondence. 
Written comments being sent via regular or express mail should be sent 
to James G. Touhey, Jr., Director, Torts Branch, Civil Division, 
Department of Justice, Room 8098N National Place Building, 1331 
Pennsylvania Avenue NW., Washington, DC 20530. Comments may also be 
sent electronically through http://www.regulations.gov using the 
electronic comment form provided on that site. An electronic copy of 
this document is also available at the http://www.regulations.gov Web 
site. The Department will accept attachments to electronic comments in 
Microsoft Word, WordPerfect, Adobe PDF, or Excel file formats only. The 
Department will not accept any file formats other than those 
specifically listed here.
    Please note that the Department is requesting that electronic 
comments be submitted before midnight Eastern Time on the day the 
comment period closes because http://www.regulations.gov terminates the 
public's ability to submit comments at midnight Eastern Time on the day 
the comment period closes. Commenters in time zones other than Eastern 
Time may want to consider this so that their electronic comments are 
received. All comments sent via regular or express mail will be 
considered timely if postmarked on the day the comment period closes.

FOR FURTHER INFORMATION CONTACT: James G. Touhey, Jr., Director, Torts 
Branch, Civil Division, Department of Justice, Washington, DC 20530, 
(202) 616-4400.

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 http://www.regulations.gov and in the Department's 
public docket. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter.
    You are not required to submit personal identifying information in 
order to comment on this rule. Nevertheless, 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 or made 
available in the public docket, you must include the phrase ``PERSONAL 
IDENTIFYING INFORMATION'' in the first paragraph of your comment. You 
must also place all the personal identifying information you do not 
want posted online or made available in the public docket 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 or made available 
in the public docket, 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

[[Page 12105]]

within the comment. If a comment has so much confidential business 
information that it cannot be effectively redacted, all or part of that 
comment may not be posted online or made available in the public 
docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be posted online and placed in 
the Department's public docket file. Please note that the Freedom of 
Information Act applies to all comments received. If you wish to 
inspect the agency's public docket file in person by appointment, 
please see the ``For Further Information'' paragraph.
Discussion
    The Federally Supported Health Centers Assistance Acts of 1992 
(Pub. L. 102-501) and 1995 (Pub. L. 104-73) amended section 224 of the 
Public Health Service Act (42 U.S.C. 233) to make the Federal Tort 
Claims Act (FTCA) (28 U.S.C. 1346(b), 2671-2680) the exclusive remedy 
for personal injury or death resulting from the performance of medical, 
surgical, dental or related functions by federally supported health 
centers and their employees, to the extent the centers and employees 
have been deemed by the Public Health Service, Department of Health and 
Human Services, to be eligible for FTCA coverage. Section 233(i) of 
title 42 provides that the Attorney General, in consultation with the 
Secretary of Health and Human Services (Secretary), may on the record 
determine, after notice and an opportunity for a full and fair hearing, 
that an individual physician or other licensed or certified health care 
practitioner who is an officer, employee, or contractor of an entity 
described in 42 U.S.C. 233(g)(4) shall not be deemed to be an employee 
of the Public Health Service for purposes of 42 U.S.C. 233 if 
``treating such individual as such an employee would expose the 
Government to an unreasonably high degree of risk of loss'' based on 
certain prescribed circumstances. This proposed rule proposes that the 
determination may be made based on one or more of the following 
statutory criteria: (1) The individual does not comply with the 
policies and procedures that the entity has implemented pursuant to 42 
U.S.C. 233(h)(1); (2) the individual has a history of claims filed 
against him or her as provided for under 42 U.S.C. 233 that is outside 
the norm for licensed or certified health care practitioners within the 
same specialty; (3) the individual refused to reasonably cooperate with 
the Attorney General in defending against any such claim; (4) the 
individual provided false information relevant to the individual's 
performance of his or her duties to the Secretary, the Attorney 
General, or an applicant for or recipient of funds under title 42 
chapter 6A; or (5) the individual was the subject of disciplinary 
action taken by a state medical licensing authority or a state or 
national professional society.
    The proposed rule proposes a process for making such a 
determination. The first step, pursuant to Sec.  15.13(a), is a 
determination by the ``initiating official,'' who is a Deputy Assistant 
Attorney General of the Department of Justice's Civil Division, that 
treating an individual as an employee of the Public Health Service may 
expose the Government to an unreasonably high degree of risk of loss. 
Section 15.13(a) requires the initiating official, after consultation 
with the Secretary of the Department of Health and Human Services, to 
provide notice to the individual in question that an administrative 
hearing will be held to determine whether treating the individual as an 
employee of the Public Health Service for purposes of 42 U.S.C. 233(g) 
would expose the United States to an unreasonably high degree of risk 
of loss. Following a period for discovery and depositions, to the 
extent determined appropriate by an administrative law judge under 
Sec.  15.15, the hearing is then conducted by the administrative law 
judge in the manner prescribed in Sec.  15.14. After the hearing is 
conducted and the record is closed, Sec.  15.16 requires the 
administrative law judge to submit written findings of fact, 
conclusions of law, and a recommended decision to the ``adjudicating 
official,'' who is the Assistant Attorney General for the Department of 
Justice's Civil Division. Section 15.17(b) then gives the parties 30 
days to submit certain additional materials, including exceptions to 
the administrative law judge's recommended decision, to the 
adjudicating official, who then must make a final agency determination 
of whether treating the individual as an employee of the Public Health 
Service for purposes of 42 U.S.C. 233(g) would expose the United States 
to an unreasonably high degree of risk of loss. Section 15.18 provides 
that an individual who is dissatisfied with the determination may seek 
rehearing within 30 days after notice of the determination is sent, and 
Sec.  15.20 allows individuals who have been determined to expose the 
United States to an unreasonably high degree of risk of loss to apply 
for reinstatement after a period of time. Consistent with 42 U.S.C. 
1320a-7e(a) and 45 CFR 60.3, 60.5(h) and 60.16, the rule also provides 
for the Department to notify the National Practitioner Data Bank 
(NPDB), a confidential information clearinghouse created by Congress 
with primary goals of improving health care quality and protecting the 
public, of the issuance of a final order deeming an individual not to 
be an employee of the Public Health Service under this rule.
    This proposed rule would add a new subpart B in part 15 of title 
28, Code of Federal Regulations, containing the regulations of the 
Department of Justice governing such a determination.
    The Department invites comments on any issues relating to the 
proposed rule.

Regulatory Flexibility Act

    The Attorney General, in accordance with the Regulatory Flexibility 
Act, 5 U.S.C. 605(b), has reviewed this proposed rule and, by approving 
it, certifies that it would not have a significant economic impact on a 
substantial number of small entities because it pertains to personnel 
and administrative matters affecting the Department.

Executive Orders 12866 and 13563: Regulatory Planning and Review

    This proposed rule has been drafted and reviewed in accordance with 
Executive Order 12866, ``Regulatory Planning and Review,'' and in 
accordance with Executive Order 13563, ``Improving Regulation and 
Regulatory Review.''
    The Department of Justice has determined that this proposed rule is 
a ``significant regulatory action'' under Executive Order 12866, 
section 3(f), and accordingly this proposed rule has been reviewed by 
the Office of Management and Budget.
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. The Department has assessed the costs and benefits of this 
proposed rule and believes that its benefits would justify its costs. 
As an initial matter, the Department does not expect that the proposed 
rule would have systemic or large-scale costs, because it is only the

[[Page 12106]]

exceptional provider who would be subject to a de-deeming proceeding or 
determination; proceedings under this proposed rule would be rare and 
would not affect the overwhelming majority of patients, providers, or 
health centers. The costs associated with the proposed rule, then, 
would come in the individual instances of its application. A de-deeming 
administrative process would impose certain limited litigation-like 
costs, but Sec. Sec.  15.14 and 15.15 provide flexibility that will 
enable the parties and administrative law judge to avoid unduly 
burdensome costs when those costs are unnecessary. In the event that an 
individual is ultimately determined to expose the United States to an 
unreasonably high degree of risk of loss, there will be certain costs 
and benefits to patients, providers, and health centers. A provider who 
is deemed not to be a member of the Public Health Service may be 
required to obtain his or her own medical malpractice insurance (as may 
the health center, for matters involving the provider that are 
determined not to be covered by the FTCA) or leave the practice. If the 
individual leaves the practice, the employing center may incur costs of 
replacing him or her with a new provider. The Department expects that 
substantial benefits will arise from such replacements, as any 
individual who is replaced will be one who has been determined to 
create an unreasonably high degree of risk of loss. It is thus likely 
that the individual's replacement will provide reduced risks of loss 
for the United States and better care for patients. While there may be 
instances in which an individual who presented such a risk of loss 
cannot be replaced, possibly resulting in impaired access to care for 
medically underserved health center patients, the Department believes 
that these costs are substantially outweighed by the benefits of 
implementing this authority.
    The Department is unable to quantify these costs at this time, as 
the authority to deem a provider not a member of the Public Health 
Service has not previously been used. However, based on the expectation 
that the authority will be used sparingly and only for providers who 
expose the United States to an unreasonably high degree of risk of 
loss, the Department has concluded that the net benefits of improved 
patient care and reduced costs of malpractice will outweigh these 
possible costs.

Executive Order 13132: Federalism

    This proposed rule would not have substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Therefore, in accordance with Executive 
Order 13132, the Department of Justice has determined that this 
proposed rule would not have sufficient federalism implications to 
warrant the preparation of a federalism summary impact statement.

Executive Order 12988: Civil Justice Reform

    This proposed rule meets the applicable standards provided in 
sections 3(a) and 3(b)(2) of Executive Order 12988.

Unfunded Mandates Reform Act of 1995

    This proposed rule would not result in the expenditure by state, 
local, and tribal governments, in the aggregate, or by the private 
sector, of $100 million 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, 2 U.S.C. 1501 et seq.

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 rule would not result in an annual effect on 
the economy of $100 million or more; a major increase in cost or 
prices; significant adverse effects on competition, employment, 
investment, productivity, or innovation; or the ability of United 
States-based enterprises to compete with foreign-based enterprises in 
domestic and export markets.

List of Subjects in 28 CFR Part 15

    Claims, Government contracts, Government employees, Health care, 
Immunization, Nuclear energy.

    For the reasons set forth in the preamble, the Attorney General 
proposes to amend part 15 of title 28 of the Code of Federal 
Regulations as follows:

PART 15--CERTIFICATIONS, DECERTIFICATIONS, AND NON-DEEMING 
DETERMINATIONS FOR PURPOSES OF THE FEDERAL TORT CLAIMS ACT

0
1. The authority citation for part 15 is revised to read as follows:

    Authority:  5 U.S.C. 301, 554, 556, 557, and 8477(e)(4); 10 
U.S.C. 1054, 1089; 22 U.S.C. 2702, 28 U.S.C. 509, 510, and 2679; 38 
U.S.C. 7316; 42 U.S.C. 233, 2212, 2458a, and 5055(f); and sec. 2, 
Pub. L. 94-380, 90 Stat. 1113 (1976).


0
2. The heading for part 15 is revised to read as set forth above.

0
3. Add a heading for subpart A to read as follows:

Subpart A--Certification and Decertification in Connection With 
Certain Suits Based Upon Acts or Omissions of Federal Employees and 
Other Persons

    Sec. Sec.  15.1, 15.2, 15.3, and 15.4 [Designated as Subpart A]

0
4. Designate Sec. Sec.  15.1 through 15.4 as subpart A.
    Sec. Sec.  15.5, 15.6, 15.7, 15.8, 15.9, and 15.10 [Added and 
Reserved]

0
5. Add reserved Sec. Sec.  15.5 through 15.10 to newly designated 
subpart A.

0
6. Add subpart B to read as follows:

Subpart B--Determination of Individuals Deemed Not To Be Employees 
of the Public Health Service

Sec.
15.11 Purpose.
15.12 Definitions.
15.13 Notice of hearing.
15.14 Conduct of hearing.
15.15 Discovery.
15.16 Recommended decision.
15.17 Final agency determination.
15.18 Rehearing.
15.19 Effective date of a final agency determination.
15.20 Reinstatement.


Sec.  15.11  Purpose.

    (a) The purpose of this regulation is to implement the notice and 
hearing procedures applicable to a determination by the Attorney 
General or his designee under 42 U.S.C. 233(i) that an individual shall 
not be deemed an employee of the Public Health Service for purposes of 
42 U.S.C. 233(g).
    (b) Section 233(i) of title 42 provides that the Attorney General, 
in consultation with the Secretary of Health and Human Services, may on 
the record determine, after notice and an opportunity for a full and 
fair hearing, that an individual physician or other licensed or 
certified health care practitioner who is an officer, employee, or 
contractor of an entity described in 42 U.S.C. 233(g)(4) shall not be 
deemed to be an employee of the Public Health Service for purposes of 
42 U.S.C. 233 if treating such individual as such an employee would 
expose the Government to an unreasonably high degree of risk of loss.


Sec.  15.12  Definitions.

    As used in this regulation:

[[Page 12107]]

    (a) Attorney General means the Attorney General of the United 
States or any designee of the Attorney General to whom authority has 
been delegated to conduct a hearing and to make a determination 
pursuant to section 233(i) of title 42, United States Code.
    (b) Adjudicating official means the Assistant Attorney General for 
the Civil Division.
    (c) Entity means an entity described in 42 U.S.C. 233(g)(4).
    (d) Health and Human Services means the Department of Health and 
Human Services or a division or component of the Department of Health 
and Human Services.
    (e) Individual means an individual physician or other licensed or 
certified health care practitioner who is or was an officer, employee, 
or contractor of an entity described in 42 U.S.C. 233(g)(4).
    (f) Initiating official means a Deputy Assistant Attorney General 
of the Civil Division of the Department of Justice or, except for 
responsibilities that the initiating official must perform personally, 
his or her designee.
    (g) Parties means an Individual, as defined in paragraph (e) of 
this section, and the Initiating official, as defined in paragraph (f) 
of this section.
    (h) Public Health Service means the Public Health Service or a 
division or component of the Public Health Service.
    (i) Secretary means the Secretary of the Department of Health and 
Human Services or the Secretary's designee.
    (j) Unreasonably high degree of risk of loss is a determination 
based on consideration of one or more of the following criteria--
    (1) The individual does not comply with the policies and procedures 
that the entity has implemented pursuant to 42 U.S.C. 233(h)(1);
    (2) The individual has a history of claims filed against him or her 
as provided for under 42 U.S.C. 233 that is outside the norm for 
licensed or certified health care practitioners within the same 
specialty;
    (3) The individual refused to reasonably cooperate with the 
Attorney General in defending against any such claim;
    (4) The individual provided false information relevant to the 
individual's performance of his or her duties to the Secretary, the 
Attorney General, or an applicant for or recipient of funds under title 
42, chapter 6A, United States Code; or
    (5) The individual was the subject of disciplinary action taken by 
a state medical licensing authority or a state or national professional 
society.


Sec.  15.13  Notice of hearing.

    (a) Whenever the initiating official personally concludes that 
treating an individual as an employee of the Public Health Service may 
expose the Government to an unreasonably high degree of risk of loss, 
the initiating official, after consultation with the Secretary, shall 
notify the individual that an administrative hearing will be conducted 
for the purpose of determining whether treating the individual as an 
employee of the Public Health Service for purposes of 42 U.S.C. 233(g) 
would expose the United States to an unreasonably high degree of risk 
of loss.
    (b) The notice of hearing shall be in writing and shall be sent by 
registered or certified mail to the individual at the individual's last 
known address, or to the individual's attorney in the event the 
Attorney General has received written notice that the individual has 
retained counsel.
    (c) The notice shall contain:
    (1) A statement of the nature and purpose of the hearing;
    (2) The name of the administrative law judge;
    (3) A statement of the nature of the action proposed to be taken; 
and
    (4) A statement of the time, date, and location of the hearing.
    (d) The hearing shall be initiated not sooner than 60 days of the 
date on the written notice of hearing.


Sec.  15.14  Conduct of hearing.

    (a) An administrative law judge appointed in accordance with 5 
U.S.C. 3105 shall preside over the hearing.
    (b) If the administrative law judge appointed is unacceptable to 
the individual, the individual shall inform the Attorney General within 
14 days of the notification of the reasons for his or her position. The 
Attorney General may select another administrative law judge, or affirm 
the initial selection. In either case, the official shall inform the 
individual of the reasons for the decision.
    (c) The administrative law judge shall have the following powers:
    (1) Administer oaths and affirmations;
    (2) Issue subpoenas authorized by law;
    (3) Rule on offers of proof and receive relevant evidence;
    (4) Take depositions or have depositions taken when the ends of 
justice would be served;
    (5) Regulate the course of the hearing;
    (6) Hold conferences for the settlement or simplification of the 
issues by consent of the parties or by the use of alternative means of 
dispute resolution;
    (7) Inform the parties as to the availability of one or more 
alternative means of dispute resolution, and encourage use of such 
methods;
    (8) Dispose of procedural requests or similar matters;
    (9) Make or recommend decisions;
    (10) Require and, in the discretion of the administrative law 
judge, adopt proposed findings of fact, conclusions of law, and orders.
    (11) Take other action authorized by agency rule consistent with 
this subchapter;
    (12) All powers and duties reasonably necessary to perform the 
functions enumerated in paragraphs (c)(1) through (11) of this section.
    (d) The administrative law judge may call upon the parties to 
consider:
    (1) Simplification or clarification of the issues;
    (2) Stipulations, admissions, agreements on documents, or other 
understandings that will expedite conduct of the hearing;
    (3) Limitation of the number of witnesses and of cumulative 
evidence;
    (4) Such other matters as may aid in the disposition of the case.
    (e) At the discretion of the administrative law judge, parties or 
witnesses may participate in hearings by video conference.
    (f) All hearings under this part shall be public unless otherwise 
ordered by the administrative law judge.
    (g) The hearing shall be conducted in conformity with 5 U.S.C. 554-
557 (sections 5-8 of the Administrative Procedure Act).
    (h) The initiating official shall have the burden of going forward 
with the evidence and shall generally present the government's evidence 
first.
    (i) Technical rules of evidence shall not apply to hearings 
conducted pursuant to this part, but rules designed to assure 
production of the most credible evidence available and to subject 
testimony to cross-examination shall be applied where reasonably 
necessary by the administrative law judge. The administrative law judge 
may exclude irrelevant, immaterial, or unduly repetitious evidence. All 
documents and other evidence offered or taken for the record shall be 
open to examination by the parties, and opportunity shall be given to 
refute facts and arguments advanced on either side of the issues. A 
transcript shall be made of the oral evidence except to the extent the 
substance thereof is stipulated for the record.
    (j) During the time a proceeding is before an administrative law 
judge, all motions shall be addressed to the administrative law judge 
and, if within

[[Page 12108]]

his or her delegated authority, shall be ruled upon. Any motion upon 
which the administrative law judge has no authority to rule shall be 
certified to the adjudicating official with a recommendation. The 
opposing party may answer within such time as may be designated by the 
administrative law judge. The administrative law judge may permit 
further replies by both parties.


Sec.  15.15  Discovery.

    (a) At any time after the initiation of the proceeding, the 
administrative law judge may order, by subpoena if necessary, the 
taking of a deposition and the production of relevant documents by the 
deponent. Such order may be entered upon a showing that the deposition 
is necessary for discovery purposes, and that such discovery could not 
be accomplished by voluntary methods. Such an order may also be entered 
in extraordinary circumstances to preserve relevant evidence upon a 
showing that there is substantial reason to believe that such evidence 
could not be presented through a witness at the hearing. The decisive 
factors for a determination under this subsection, however, shall be 
fairness to all parties and the requirements of due process. A 
deposition may be taken orally or upon written questions before any 
person who has the power to administer oaths and shall not exceed one 
day of seven hours.
    (b) Each deponent shall be duly sworn, and any adverse party shall 
have the right to cross-examine. Objections to questions or documents 
shall be in short form, stating the grounds upon which objections are 
made. The questions propounded and the answers thereto, together with 
all objections made (but not including argument or debate), shall be 
reduced to writing and certified by the person before whom the 
deposition was taken. Thereafter, the person taking the deposition 
shall forward the deposition and one (1) copy thereof to the party at 
whose instance the deposition was taken and shall forward one (1) copy 
to the representative of the other party.
    (c) A deposition may be admitted into evidence as against any party 
who was present or represented at the taking of the deposition, or who 
had due notice thereof, if the administrative law judge finds that 
there are sufficient reasons for admission and that the admission of 
the evidence would be fair to all parties and comport with the 
requirements of due process.


Sec.  15.16  Recommended decision.

    Within a reasonable time after the close of the record of the 
hearings conducted under Sec.  15.14, the administrative law judge 
shall submit written findings of fact, conclusions of law, and a 
recommended decision to the adjudicating official. The administrative 
law judge shall promptly make copies of these documents available to 
the parties and the Secretary.


Sec.  15.17  Final agency determination.

    (a) In hearings conducted under Sec.  15.14, the adjudicating 
official shall make the final agency determination, on the basis of the 
record, findings, conclusions, and recommendations presented by the 
administrative law judge.
    (b) Prior to making a final agency determination, the adjudicating 
official shall give the parties an opportunity to submit the following, 
within thirty (30) days after the submission of the administrative law 
judge's recommendations:
    (1) Proposed findings and determinations;
    (2) Exceptions to the recommendations of the administrative law 
judge;
    (3) Supporting reasons for the exceptions or proposed findings or 
determinations; and
    (4) Final briefs summarizing the arguments presented at the 
hearing.
    (c) All determinations made by the adjudicating official under this 
rule shall constitute final agency actions. After a final agency 
determination under this rule that an individual shall not be deemed to 
be an employee of the Public Health Service, such individual will be 
deemed not to be an employee of the Public Health Service except 
pursuant to Sec.  15.20.


Sec.  15.18  Rehearing.

    (a) An individual dissatisfied with a final agency determination 
under Sec.  15.17 may, within 30 days after the notice of the final 
agency determination is sent, request the adjudicating official to re-
review the record, and may present additional evidence that is 
appropriate and pertinent to support a different decision.
    (b) The adjudicating official may require that another oral hearing 
be held on one or more of the issues in controversy, or permit the 
dissatisfied party to present further evidence or argument in writing, 
if the adjudicating official finds that the individual has:
    (1) Presented evidence or argument that is sufficiently significant 
to require the conduct of further proceedings; or
    (2) Shown some defect in the conduct of the adjudication under this 
subpart sufficient to cause substantial unfairness or an erroneous 
finding in that adjudication.
    (c) Any rehearing ordered by the adjudicating official shall be 
conducted pursuant to Sec. Sec.  15.13 through 15.16.
    (d) A determination that an individual may be deemed to be an 
employee of the Public Health Service for purposes of 42 U.S.C. 233 
pursuant to this section shall be distributed in the same manner as 
provided in Sec.  15.19.


Sec.  15.19  Effective date of a final agency determination.

    (a) A final agency determination under Sec.  15.17 that an 
individual shall not be deemed to be an employee of the Public Health 
Service for purposes of 42 U.S.C. 233 shall be provided to the 
Department of Health and Human Services and sent by certified or 
registered mail to the individual and to the entity employing such 
individual if the individual is currently an officer, employee, or 
contractor of an entity described in 42 U.S.C. 233(g)(4). In the event 
the individual is no longer an officer, employee, or contractor of such 
an entity, the determination shall be sent by certified or registered 
mail to the individual and to the last entity described in 42 U.S.C. 
233(g)(4) at which such individual was an officer, employee, or 
contractor.
    (b) A final agency determination shall be effective upon the date 
the written determination is received by such entity.
    (c) An adverse final agency determination shall apply to all acts 
or omissions of the individual occurring after the date the adverse 
final determination is received by such entity.
    (d) The Attorney General will inform the National Practitioner Data 
Bank of any final agency determination under Sec.  15.17 that an 
individual shall not be deemed to be an employee of the Public Health 
Service for purposes of 42 U.S.C. 233.


Sec.  15.20  Reinstatement.

    (a) No less than five years after the time for rehearing has 
expired, and no more often than every five years, an individual who has 
been the subject of a final agency determination under Sec.  15.17 may 
petition the Attorney General for reconsideration of that determination 
and reinstatement. The individual bears the burden of proof and 
persuasion.
    (b) In support of the petition for reinstatement, the individual 
shall submit relevant evidence relating to the period since the 
original proceedings under this subpart and a statement

[[Page 12109]]

demonstrating that treating the individual as an employee of the Public 
Health Service for purposes of 42 U.S.C. 233(g) would no longer expose 
the United States to an unreasonably high degree of risk of loss.
    (c) Upon receiving a petition for reinstatement, the initiating 
official shall determine, in the initiating official's unreviewable 
discretion, whether the petition makes a prima facie case that no 
longer would expose the United States to an unreasonably high degree of 
risk of loss. The initiating official's determination that a petition 
does not make a prima facie case is not subject to further review.
    (d) Upon a prima facie case having been made, an administrative law 
judge shall be appointed in accordance with 5 U.S.C. 3105 and shall 
conduct such proceedings pursuant to Sec. Sec.  15.13 through 15.16 as 
the administrative law judge deems necessary, in his or her sole 
discretion, to determine whether the individual has established that 
treating the individual as an employee of the Public Health Service for 
purposes of 42 U.S.C. 233(g) would no longer expose the United States 
to an unreasonably high degree of risk of loss, and shall submit 
written findings of fact, conclusions of law, and a recommended 
decision to the adjudicating official pursuant to Sec.  15.16.
    (e) On a petition for reinstatement, the adjudicating official 
shall make the final agency determination, on the basis of the record, 
findings, conclusions, and recommendations presented by the 
administrative law judge, which shall include the record from the 
original determination and any petition for rehearing. All 
determinations made by the adjudicating official under this rule shall 
constitute final agency actions.
    (f) A determination that an individual is reinstated pursuant to 
this section shall be distributed in the same manner as provided in 
Sec.  15.19.

    Dated: February 25, 2015.
Eric H. Holder, Jr.,
Attorney General.
[FR Doc. 2015-05027 Filed 3-5-15; 8:45 am]
BILLING CODE 4410-12-P



                                                 12104                     Federal Register / Vol. 80, No. 44 / Friday, March 6, 2015 / Proposed Rules

                                                 S was a member of the P group. Under                    extraordinary item (see paragraph                     electronic comment form provided on
                                                 § 1.1502–32(b)(2)(i), P’s basis in its S stock is       (b)(2)(ii)(C)(9) of this section) that becomes        that site. An electronic copy of this
                                                 increased to reflect S’s $40 gain immediately           deductible on July 1 simultaneously with the          document is also available at the
                                                 before the redemption of S’s stock.                     event that terminates S’s election as an S
                                                                                                                                                               http://www.regulations.gov Web site.
                                                    (c) Partial redemption. The facts are the            corporation. Under paragraph (b)(1)(ii)(B)(2)
                                                 same as in paragraph (a) of this Example 9,             of this section, S’s obligation to pay the fee        The Department will accept attachments
                                                 except that S distributes the land to P in              is treated as becoming deductible on June 30          to electronic comments in Microsoft
                                                 redemption of 20 shares of P’s stock in S.              under the previous day rule.                          Word, WordPerfect, Adobe PDF, or
                                                 Thus, immediately after the redemption, P                                                                     Excel file formats only. The Department
                                                 owns 75% (60 shares/80 shares) of S’s                      (6) Effective/applicability date.                  will not accept any file formats other
                                                 outstanding stock, and S’s minority                     Paragraphs (b)(2)(i) and (b)(4) of this               than those specifically listed here.
                                                 shareholder owns 25% (20 shares/80 shares).             section apply to consolidated return                     Please note that the Department is
                                                 The redemption does not satisfy the                     years beginning on or after the date                  requesting that electronic comments be
                                                 requirements of section 302(b) and is treated           these regulations are published as final
                                                 under section 302(d) as a distribution to                                                                     submitted before midnight Eastern Time
                                                                                                         regulations in the Federal Register.                  on the day the comment period closes
                                                 which section 301 applies. The end of the               Otherwise, this paragraph (b) applies to
                                                 day rule does not apply for purposes of                                                                       because http://www.regulations.gov
                                                 determining whether P and S are members of
                                                                                                         corporations becoming or ceasing to be                terminates the public’s ability to submit
                                                 the same consolidated group immediately                 members of consolidated groups on or                  comments at midnight Eastern Time on
                                                 after the redemption. Because P owns only               after the date these regulations are                  the day the comment period closes.
                                                 75% of S’s stock immediately after the                  published as final regulations in the                 Commenters in time zones other than
                                                 redemption, the distribution is not an                  Federal Register.                                     Eastern Time may want to consider this
                                                 intercompany distribution described in                  *      *     *    *     *
                                                 § 1.1502–13(f)(2)(i). Thus, P may not exclude
                                                                                                                                                               so that their electronic comments are
                                                 any amount of the distribution that is a                John Dalrymple,                                       received. All comments sent via regular
                                                 dividend, and P’s basis in S’s stock is not             Deputy Commissioner for Services and
                                                                                                                                                               or express mail will be considered
                                                 reduced under § 1.1502–32(b)(2)(iv). P may              Enforcement.                                          timely if postmarked on the day the
                                                 be entitled to a dividends received deduction
                                                                                                         [FR Doc. 2015–05123 Filed 3–5–15; 8:45 am]
                                                                                                                                                               comment period closes.
                                                 under section 243(c) (but see section                                                                         FOR FURTHER INFORMATION CONTACT:
                                                 1059(e)). For the reasons discussed in                  BILLING CODE 4830–01–P
                                                                                                                                                               James G. Touhey, Jr., Director, Torts
                                                 paragraph (b) of this Example 9, S’s gain
                                                                                                                                                               Branch, Civil Division, Department of
                                                 under section 311(b) must be reported under
                                                 the end of the day rule in S’s taxable year                                                                   Justice, Washington, DC 20530, (202)
                                                                                                         DEPARTMENT OF JUSTICE                                 616–4400.
                                                 ending June 30, during which S was a
                                                 member of the P group.                                  28 CFR Part 15                                        SUPPLEMENTARY INFORMATION:
                                                    (d) Distribution of loss property. The facts                                                                  Posting of Public Comments. Please
                                                 are the same as in paragraph (a) of this                [Docket No. CIV 150; AG Order No. 3504–               note that all comments received are
                                                 Example 9, except that the land distributed             2015]                                                 considered part of the public record and
                                                 by S to P has a fair market value of $60 rather                                                               made available for public inspection
                                                 than $140. The end of the day rule applies              RIN 1105–AB37
                                                 for purposes of determining the taxable year
                                                                                                                                                               online at http://www.regulations.gov
                                                 in which S must take into account its                   Determination That an Individual Shall                and in the Department’s public docket.
                                                 realized loss on the distribution of the land.          Not Be Deemed an Employee of the                      Such information includes personal
                                                 Thus, under the end of the day rule, S’s loss           Public Health Service                                 identifying information (such as your
                                                 on the distribution of the land, which occurs                                                                 name, address, etc.) voluntarily
                                                 simultaneously with S’s ceasing to be a                 AGENCY:    Department of Justice.                     submitted by the commenter.
                                                 member, is taken into account in S’s taxable            ACTION:   Proposed rule.                                 You are not required to submit
                                                 year that ends as a result of the redemption.                                                                 personal identifying information in
                                                 However, the end of the day rule does not               SUMMARY:   The proposed rule proposes                 order to comment on this rule.
                                                 apply for other purposes; for example, the              criteria and a process by which the                   Nevertheless, if you want to submit
                                                 rule does not apply in determining whether              Attorney General or designee may
                                                 the transaction is an intercompany                                                                            personal identifying information (such
                                                                                                         determine that an individual shall not                as your name, address, etc.) as part of
                                                 distribution or in determining the attributes           be deemed an employee of the Public
                                                 (as defined in § 1.1502–13(b)(6)) of the loss.                                                                your comment, but do not want it to be
                                                                                                         Health Service for purposes of coverage               posted online or made available in the
                                                 Therefore, because S is not a member
                                                 immediately after the distribution, S’s loss on         under the Federal Tort Claims Act.                    public docket, you must include the
                                                 the distribution is not recognized under                DATES: Written comments must be                       phrase ‘‘PERSONAL IDENTIFYING
                                                 section 311(a). Under the end of the day rule,          postmarked on or before May 5, 2015,                  INFORMATION’’ in the first paragraph
                                                 the loss is taken into account as a noncapital,         and electronic comments must be sent                  of your comment. You must also place
                                                 nondeductible expense on the P group’s                  on or before midnight Eastern time May                all the personal identifying information
                                                 consolidated return, and under § 1.1502–                5, 2015.
                                                 32(b)(1)(i), P’s basis in its S stock is                                                                      you do not want posted online or made
                                                 decreased by $40 immediately before S                   ADDRESSES: To ensure proper handling                  available in the public docket in the first
                                                 leaves the group.                                       of comments, please reference ‘‘Docket                paragraph of your comment and identify
                                                    Example 10. Extraordinary item of S                  No. CIV 150’’ on all written and                      what information you want redacted.
                                                 corporation—(a) Facts. On July 1, P                     electronic correspondence. Written                       If you want to submit confidential
                                                 purchases all the stock of S, an accrual-basis          comments being sent via regular or                    business information as part of your
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                                                 corporation with an election in effect under            express mail should be sent to James G.               comment, but do not want it to be
                                                 section 1362(a). Prior to the sale, S had               Touhey, Jr., Director, Torts Branch, Civil            posted online or made available in the
                                                 engaged a consulting firm to find a buyer for
                                                                                                         Division, Department of Justice, Room                 public docket, you must include the
                                                 S’s stock, and the consulting firm’s fee was
                                                 contingent upon the successful closing of the           8098N National Place Building, 1331                   phrase ‘‘CONFIDENTIAL BUSINESS
                                                 sale of S’s stock.                                      Pennsylvania Avenue NW., Washington,                  INFORMATION’’ in the first paragraph
                                                    (b) Analysis. To the extent S’s payment of           DC 20530. Comments may also be sent                   of your comment. You must also
                                                 the success-based fee to its consultants is             electronically through http://                        prominently identify confidential
                                                 otherwise deductible, this item is an                   www.regulations.gov using the                         business information to be redacted


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                                                                           Federal Register / Vol. 80, No. 44 / Friday, March 6, 2015 / Proposed Rules                                          12105

                                                 within the comment. If a comment has                    Attorney General in defending against                 a period of time. Consistent with 42
                                                 so much confidential business                           any such claim; (4) the individual                    U.S.C. 1320a–7e(a) and 45 CFR 60.3,
                                                 information that it cannot be effectively               provided false information relevant to                60.5(h) and 60.16, the rule also provides
                                                 redacted, all or part of that comment                   the individual’s performance of his or                for the Department to notify the
                                                 may not be posted online or made                        her duties to the Secretary, the Attorney             National Practitioner Data Bank (NPDB),
                                                 available in the public docket.                         General, or an applicant for or recipient             a confidential information
                                                   Personal identifying information and                  of funds under title 42 chapter 6A; or (5)            clearinghouse created by Congress with
                                                 confidential business information                       the individual was the subject of                     primary goals of improving health care
                                                 identified and located as set forth above               disciplinary action taken by a state                  quality and protecting the public, of the
                                                 will be redacted and the comment, in                    medical licensing authority or a state or             issuance of a final order deeming an
                                                 redacted form, will be posted online and                national professional society.                        individual not to be an employee of the
                                                 placed in the Department’s public                          The proposed rule proposes a process               Public Health Service under this rule.
                                                 docket file. Please note that the Freedom               for making such a determination. The                     This proposed rule would add a new
                                                 of Information Act applies to all                       first step, pursuant to § 15.13(a), is a              subpart B in part 15 of title 28, Code of
                                                 comments received. If you wish to                       determination by the ‘‘initiating                     Federal Regulations, containing the
                                                 inspect the agency’s public docket file                 official,’’ who is a Deputy Assistant                 regulations of the Department of Justice
                                                 in person by appointment, please see                    Attorney General of the Department of                 governing such a determination.
                                                 the ‘‘For Further Information’’                         Justice’s Civil Division, that treating an               The Department invites comments on
                                                 paragraph.                                              individual as an employee of the Public               any issues relating to the proposed rule.
                                                 Discussion                                              Health Service may expose the                         Regulatory Flexibility Act
                                                    The Federally Supported Health                       Government to an unreasonably high                      The Attorney General, in accordance
                                                 Centers Assistance Acts of 1992 (Pub. L.                degree of risk of loss. Section 15.13(a)              with the Regulatory Flexibility Act, 5
                                                 102–501) and 1995 (Pub. L. 104–73)                      requires the initiating official, after               U.S.C. 605(b), has reviewed this
                                                 amended section 224 of the Public                       consultation with the Secretary of the                proposed rule and, by approving it,
                                                 Health Service Act (42 U.S.C. 233) to                   Department of Health and Human                        certifies that it would not have a
                                                 make the Federal Tort Claims Act                        Services, to provide notice to the                    significant economic impact on a
                                                 (FTCA) (28 U.S.C. 1346(b), 2671–2680)                   individual in question that an                        substantial number of small entities
                                                 the exclusive remedy for personal injury                administrative hearing will be held to                because it pertains to personnel and
                                                 or death resulting from the performance                 determine whether treating the                        administrative matters affecting the
                                                 of medical, surgical, dental or related                 individual as an employee of the Public               Department.
                                                 functions by federally supported health                 Health Service for purposes of 42 U.S.C.
                                                 centers and their employees, to the                     233(g) would expose the United States                 Executive Orders 12866 and 13563:
                                                 extent the centers and employees have                   to an unreasonably high degree of risk                Regulatory Planning and Review
                                                 been deemed by the Public Health                        of loss. Following a period for discovery                This proposed rule has been drafted
                                                 Service, Department of Health and                       and depositions, to the extent                        and reviewed in accordance with
                                                 Human Services, to be eligible for FTCA                 determined appropriate by an                          Executive Order 12866, ‘‘Regulatory
                                                 coverage. Section 233(i) of title 42                    administrative law judge under § 15.15,               Planning and Review,’’ and in
                                                 provides that the Attorney General, in                  the hearing is then conducted by the                  accordance with Executive Order 13563,
                                                 consultation with the Secretary of                      administrative law judge in the manner                ‘‘Improving Regulation and Regulatory
                                                 Health and Human Services (Secretary),                  prescribed in § 15.14. After the hearing              Review.’’
                                                 may on the record determine, after                      is conducted and the record is closed,                   The Department of Justice has
                                                 notice and an opportunity for a full and                § 15.16 requires the administrative law               determined that this proposed rule is a
                                                 fair hearing, that an individual                        judge to submit written findings of fact,             ‘‘significant regulatory action’’ under
                                                 physician or other licensed or certified                conclusions of law, and a recommended                 Executive Order 12866, section 3(f), and
                                                 health care practitioner who is an                      decision to the ‘‘adjudicating official,’’            accordingly this proposed rule has been
                                                 officer, employee, or contractor of an                  who is the Assistant Attorney General                 reviewed by the Office of Management
                                                 entity described in 42 U.S.C. 233(g)(4)                 for the Department of Justice’s Civil                 and Budget.
                                                 shall not be deemed to be an employee                   Division. Section 15.17(b) then gives the                Executive Orders 12866 and 13563
                                                 of the Public Health Service for                        parties 30 days to submit certain                     direct agencies to assess all costs and
                                                 purposes of 42 U.S.C. 233 if ‘‘treating                 additional materials, including                       benefits of available regulatory
                                                 such individual as such an employee                     exceptions to the administrative law                  alternatives and, if regulation is
                                                 would expose the Government to an                       judge’s recommended decision, to the                  necessary, to select regulatory
                                                 unreasonably high degree of risk of                     adjudicating official, who then must                  approaches that maximize net benefits
                                                 loss’’ based on certain prescribed                      make a final agency determination of                  (including potential economic,
                                                 circumstances. This proposed rule                       whether treating the individual as an                 environmental, public health and safety
                                                 proposes that the determination may be                  employee of the Public Health Service                 effects, distributive impacts, and
                                                 made based on one or more of the                        for purposes of 42 U.S.C. 233(g) would                equity). Executive Order 13563
                                                 following statutory criteria: (1) The                   expose the United States to an                        emphasizes the importance of
                                                 individual does not comply with the                     unreasonably high degree of risk of loss.             quantifying both costs and benefits, of
                                                 policies and procedures that the entity                 Section 15.18 provides that an                        reducing costs, of harmonizing rules,
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                                                 has implemented pursuant to 42 U.S.C.                   individual who is dissatisfied with the               and of promoting flexibility. The
                                                 233(h)(1); (2) the individual has a                     determination may seek rehearing                      Department has assessed the costs and
                                                 history of claims filed against him or her              within 30 days after notice of the                    benefits of this proposed rule and
                                                 as provided for under 42 U.S.C. 233 that                determination is sent, and § 15.20                    believes that its benefits would justify
                                                 is outside the norm for licensed or                     allows individuals who have been                      its costs. As an initial matter, the
                                                 certified health care practitioners within              determined to expose the United States                Department does not expect that the
                                                 the same specialty; (3) the individual                  to an unreasonably high degree of risk                proposed rule would have systemic or
                                                 refused to reasonably cooperate with the                of loss to apply for reinstatement after              large-scale costs, because it is only the


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                                                 12106                     Federal Register / Vol. 80, No. 44 / Friday, March 6, 2015 / Proposed Rules

                                                 exceptional provider who would be                       distribution of power and                             7316; 42 U.S.C. 233, 2212, 2458a, and
                                                 subject to a de-deeming proceeding or                   responsibilities among the various                    5055(f); and sec. 2, Pub. L. 94–380, 90 Stat.
                                                 determination; proceedings under this                   levels of government. Therefore, in                   1113 (1976).
                                                 proposed rule would be rare and would                   accordance with Executive Order 13132,                ■ 2. The heading for part 15 is revised
                                                 not affect the overwhelming majority of                 the Department of Justice has                         to read as set forth above.
                                                 patients, providers, or health centers.                 determined that this proposed rule                    ■ 3. Add a heading for subpart A to read
                                                 The costs associated with the proposed                  would not have sufficient federalism                  as follows:
                                                 rule, then, would come in the                           implications to warrant the preparation
                                                 individual instances of its application.                of a federalism summary impact                        Subpart A—Certification and
                                                 A de-deeming administrative process                     statement.                                            Decertification in Connection With
                                                 would impose certain limited litigation-                                                                      Certain Suits Based Upon Acts or
                                                 like costs, but §§ 15.14 and 15.15                      Executive Order 12988: Civil Justice                  Omissions of Federal Employees and
                                                 provide flexibility that will enable the                Reform                                                Other Persons
                                                 parties and administrative law judge to                   This proposed rule meets the
                                                 avoid unduly burdensome costs when                      applicable standards provided in                        §§ 15.1, 15.2, 15.3, and 15.4
                                                 those costs are unnecessary. In the event               sections 3(a) and 3(b)(2) of Executive                [Designated as Subpart A]
                                                                                                                                                               ■ 4. Designate §§ 15.1 through 15.4 as
                                                 that an individual is ultimately                        Order 12988.
                                                 determined to expose the United States                                                                        subpart A.
                                                                                                         Unfunded Mandates Reform Act of                         §§ 15.5, 15.6, 15.7, 15.8, 15.9, and
                                                 to an unreasonably high degree of risk
                                                                                                         1995                                                  15.10 [Added and Reserved]
                                                 of loss, there will be certain costs and
                                                                                                            This proposed rule would not result                ■ 5. Add reserved §§ 15.5 through 15.10
                                                 benefits to patients, providers, and
                                                 health centers. A provider who is                       in the expenditure by state, local, and               to newly designated subpart A.
                                                                                                         tribal governments, in the aggregate, or              ■ 6. Add subpart B to read as follows:
                                                 deemed not to be a member of the
                                                 Public Health Service may be required                   by the private sector, of $100 million or
                                                                                                                                                               Subpart B—Determination of
                                                 to obtain his or her own medical                        more in any one year, and it will not
                                                                                                                                                               Individuals Deemed Not To Be
                                                 malpractice insurance (as may the                       significantly or uniquely affect small
                                                                                                                                                               Employees of the Public Health
                                                 health center, for matters involving the                governments. Therefore, no actions were
                                                                                                                                                               Service
                                                 provider that are determined not to be                  deemed necessary under the provisions
                                                 covered by the FTCA) or leave the                       of the Unfunded Mandates Reform Act                   Sec.
                                                 practice. If the individual leaves the                  of 1995, 2 U.S.C. 1501 et seq.                        15.11 Purpose.
                                                 practice, the employing center may                                                                            15.12 Definitions.
                                                                                                         Small Business Regulatory Enforcement                 15.13 Notice of hearing.
                                                 incur costs of replacing him or her with
                                                                                                         Fairness Act of 1996                                  15.14 Conduct of hearing.
                                                 a new provider. The Department expects
                                                                                                           This proposed rule is not a major rule              15.15 Discovery.
                                                 that substantial benefits will arise from
                                                                                                         as defined by section 251 of the Small                15.16 Recommended decision.
                                                 such replacements, as any individual                                                                          15.17 Final agency determination.
                                                 who is replaced will be one who has                     Business Regulatory Enforcement                       15.18 Rehearing.
                                                 been determined to create an                            Fairness Act of 1996, 5 U.S.C. 804. This              15.19 Effective date of a final agency
                                                 unreasonably high degree of risk of loss.               proposed rule would not result in an                       determination.
                                                 It is thus likely that the individual’s                 annual effect on the economy of $100                  15.20 Reinstatement.
                                                 replacement will provide reduced risks                  million or more; a major increase in cost
                                                 of loss for the United States and better                or prices; significant adverse effects on             § 15.11    Purpose.
                                                 care for patients. While there may be                   competition, employment, investment,                     (a) The purpose of this regulation is
                                                 instances in which an individual who                    productivity, or innovation; or the                   to implement the notice and hearing
                                                 presented such a risk of loss cannot be                 ability of United States-based                        procedures applicable to a
                                                 replaced, possibly resulting in impaired                enterprises to compete with foreign-                  determination by the Attorney General
                                                 access to care for medically underserved                based enterprises in domestic and                     or his designee under 42 U.S.C. 233(i)
                                                 health center patients, the Department                  export markets.                                       that an individual shall not be deemed
                                                 believes that these costs are                                                                                 an employee of the Public Health
                                                                                                         List of Subjects in 28 CFR Part 15                    Service for purposes of 42 U.S.C. 233(g).
                                                 substantially outweighed by the benefits
                                                 of implementing this authority.                           Claims, Government contracts,                          (b) Section 233(i) of title 42 provides
                                                    The Department is unable to quantify                 Government employees, Health care,                    that the Attorney General, in
                                                 these costs at this time, as the authority              Immunization, Nuclear energy.                         consultation with the Secretary of
                                                 to deem a provider not a member of the                    For the reasons set forth in the                    Health and Human Services, may on the
                                                 Public Health Service has not                           preamble, the Attorney General                        record determine, after notice and an
                                                 previously been used. However, based                    proposes to amend part 15 of title 28 of              opportunity for a full and fair hearing,
                                                 on the expectation that the authority                   the Code of Federal Regulations as                    that an individual physician or other
                                                 will be used sparingly and only for                     follows:                                              licensed or certified health care
                                                 providers who expose the United States                                                                        practitioner who is an officer, employee,
                                                 to an unreasonably high degree of risk                  PART 15—CERTIFICATIONS,                               or contractor of an entity described in
                                                 of loss, the Department has concluded                   DECERTIFICATIONS, AND NON–                            42 U.S.C. 233(g)(4) shall not be deemed
                                                 that the net benefits of improved patient               DEEMING DETERMINATIONS FOR                            to be an employee of the Public Health
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                                                 care and reduced costs of malpractice                   PURPOSES OF THE FEDERAL TORT                          Service for purposes of 42 U.S.C. 233 if
                                                 will outweigh these possible costs.                     CLAIMS ACT                                            treating such individual as such an
                                                                                                                                                               employee would expose the
                                                 Executive Order 13132: Federalism                       ■ 1. The authority citation for part 15 is            Government to an unreasonably high
                                                   This proposed rule would not have                     revised to read as follows:                           degree of risk of loss.
                                                 substantial direct effects on the States,                 Authority: 5 U.S.C. 301, 554, 556, 557, and
                                                 on the relationship between the national                8477(e)(4); 10 U.S.C. 1054, 1089; 22 U.S.C.           § 15.12    Definitions.
                                                 government and the States, or on the                    2702, 28 U.S.C. 509, 510, and 2679; 38 U.S.C.             As used in this regulation:


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                                                                           Federal Register / Vol. 80, No. 44 / Friday, March 6, 2015 / Proposed Rules                                           12107

                                                    (a) Attorney General means the                       § 15.13   Notice of hearing.                            (7) Inform the parties as to the
                                                 Attorney General of the United States or                  (a) Whenever the initiating official                availability of one or more alternative
                                                 any designee of the Attorney General to                 personally concludes that treating an                 means of dispute resolution, and
                                                 whom authority has been delegated to                    individual as an employee of the Public               encourage use of such methods;
                                                 conduct a hearing and to make a                         Health Service may expose the                           (8) Dispose of procedural requests or
                                                 determination pursuant to section 233(i)                Government to an unreasonably high                    similar matters;
                                                 of title 42, United States Code.                        degree of risk of loss, the initiating                  (9) Make or recommend decisions;
                                                    (b) Adjudicating official means the                  official, after consultation with the                   (10) Require and, in the discretion of
                                                 Assistant Attorney General for the Civil                Secretary, shall notify the individual                the administrative law judge, adopt
                                                 Division.                                               that an administrative hearing will be                proposed findings of fact, conclusions of
                                                    (c) Entity means an entity described in              conducted for the purpose of                          law, and orders.
                                                 42 U.S.C. 233(g)(4).                                    determining whether treating the                        (11) Take other action authorized by
                                                                                                         individual as an employee of the Public               agency rule consistent with this
                                                    (d) Health and Human Services
                                                                                                         Health Service for purposes of 42 U.S.C.              subchapter;
                                                 means the Department of Health and
                                                                                                         233(g) would expose the United States                   (12) All powers and duties reasonably
                                                 Human Services or a division or
                                                                                                         to an unreasonably high degree of risk                necessary to perform the functions
                                                 component of the Department of Health
                                                                                                         of loss.                                              enumerated in paragraphs (c)(1) through
                                                 and Human Services.
                                                                                                           (b) The notice of hearing shall be in               (11) of this section.
                                                    (e) Individual means an individual                                                                           (d) The administrative law judge may
                                                 physician or other licensed or certified                writing and shall be sent by registered
                                                                                                         or certified mail to the individual at the            call upon the parties to consider:
                                                 health care practitioner who is or was                                                                          (1) Simplification or clarification of
                                                 an officer, employee, or contractor of an               individual’s last known address, or to
                                                                                                         the individual’s attorney in the event                the issues;
                                                 entity described in 42 U.S.C. 233(g)(4).                                                                        (2) Stipulations, admissions,
                                                    (f) Initiating official means a Deputy               the Attorney General has received
                                                                                                         written notice that the individual has                agreements on documents, or other
                                                 Assistant Attorney General of the Civil                                                                       understandings that will expedite
                                                 Division of the Department of Justice or,               retained counsel.
                                                                                                           (c) The notice shall contain:                       conduct of the hearing;
                                                 except for responsibilities that the                                                                            (3) Limitation of the number of
                                                                                                           (1) A statement of the nature and
                                                 initiating official must perform                                                                              witnesses and of cumulative evidence;
                                                                                                         purpose of the hearing;
                                                 personally, his or her designee.                          (2) The name of the administrative                    (4) Such other matters as may aid in
                                                    (g) Parties means an Individual, as                  law judge;                                            the disposition of the case.
                                                 defined in paragraph (e) of this section,                 (3) A statement of the nature of the                  (e) At the discretion of the
                                                 and the Initiating official, as defined in              action proposed to be taken; and                      administrative law judge, parties or
                                                 paragraph (f) of this section.                            (4) A statement of the time, date, and              witnesses may participate in hearings by
                                                    (h) Public Health Service means the                  location of the hearing.                              video conference.
                                                 Public Health Service or a division or                    (d) The hearing shall be initiated not                (f) All hearings under this part shall
                                                 component of the Public Health Service.                 sooner than 60 days of the date on the                be public unless otherwise ordered by
                                                    (i) Secretary means the Secretary of                 written notice of hearing.                            the administrative law judge.
                                                 the Department of Health and Human                                                                              (g) The hearing shall be conducted in
                                                 Services or the Secretary’s designee.                   § 15.14   Conduct of hearing.                         conformity with 5 U.S.C. 554–557
                                                    (j) Unreasonably high degree of risk of                (a) An administrative law judge                     (sections 5–8 of the Administrative
                                                 loss is a determination based on                        appointed in accordance with 5 U.S.C.                 Procedure Act).
                                                                                                         3105 shall preside over the hearing.                    (h) The initiating official shall have
                                                 consideration of one or more of the
                                                                                                           (b) If the administrative law judge                 the burden of going forward with the
                                                 following criteria—
                                                                                                         appointed is unacceptable to the                      evidence and shall generally present the
                                                    (1) The individual does not comply                                                                         government’s evidence first.
                                                 with the policies and procedures that                   individual, the individual shall inform
                                                                                                         the Attorney General within 14 days of                  (i) Technical rules of evidence shall
                                                 the entity has implemented pursuant to                                                                        not apply to hearings conducted
                                                 42 U.S.C. 233(h)(1);                                    the notification of the reasons for his or
                                                                                                         her position. The Attorney General may                pursuant to this part, but rules designed
                                                    (2) The individual has a history of                                                                        to assure production of the most
                                                                                                         select another administrative law judge,
                                                 claims filed against him or her as                                                                            credible evidence available and to
                                                                                                         or affirm the initial selection. In either
                                                 provided for under 42 U.S.C. 233 that is                                                                      subject testimony to cross-examination
                                                                                                         case, the official shall inform the
                                                 outside the norm for licensed or                                                                              shall be applied where reasonably
                                                                                                         individual of the reasons for the
                                                 certified health care practitioners within                                                                    necessary by the administrative law
                                                                                                         decision.
                                                 the same specialty;                                                                                           judge. The administrative law judge
                                                                                                           (c) The administrative law judge shall
                                                    (3) The individual refused to                        have the following powers:                            may exclude irrelevant, immaterial, or
                                                 reasonably cooperate with the Attorney                    (1) Administer oaths and affirmations;              unduly repetitious evidence. All
                                                 General in defending against any such                     (2) Issue subpoenas authorized by                   documents and other evidence offered
                                                 claim;                                                  law;                                                  or taken for the record shall be open to
                                                    (4) The individual provided false                      (3) Rule on offers of proof and receive             examination by the parties, and
                                                 information relevant to the individual’s                relevant evidence;                                    opportunity shall be given to refute facts
                                                 performance of his or her duties to the                   (4) Take depositions or have                        and arguments advanced on either side
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                                                 Secretary, the Attorney General, or an                  depositions taken when the ends of                    of the issues. A transcript shall be made
                                                 applicant for or recipient of funds under               justice would be served;                              of the oral evidence except to the extent
                                                 title 42, chapter 6A, United States Code;                 (5) Regulate the course of the hearing;             the substance thereof is stipulated for
                                                 or                                                        (6) Hold conferences for the                        the record.
                                                    (5) The individual was the subject of                settlement or simplification of the issues              (j) During the time a proceeding is
                                                 disciplinary action taken by a state                    by consent of the parties or by the use               before an administrative law judge, all
                                                 medical licensing authority or a state or               of alternative means of dispute                       motions shall be addressed to the
                                                 national professional society.                          resolution;                                           administrative law judge and, if within


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                                                 12108                     Federal Register / Vol. 80, No. 44 / Friday, March 6, 2015 / Proposed Rules

                                                 his or her delegated authority, shall be                § 15.16   Recommended decision.                       sufficient to cause substantial unfairness
                                                 ruled upon. Any motion upon which                         Within a reasonable time after the                  or an erroneous finding in that
                                                 the administrative law judge has no                     close of the record of the hearings                   adjudication.
                                                 authority to rule shall be certified to the             conducted under § 15.14, the                            (c) Any rehearing ordered by the
                                                 adjudicating official with a                            administrative law judge shall submit                 adjudicating official shall be conducted
                                                 recommendation. The opposing party                      written findings of fact, conclusions of              pursuant to §§ 15.13 through 15.16.
                                                 may answer within such time as may be                   law, and a recommended decision to the                  (d) A determination that an individual
                                                 designated by the administrative law                    adjudicating official. The administrative             may be deemed to be an employee of the
                                                 judge. The administrative law judge                     law judge shall promptly make copies of               Public Health Service for purposes of 42
                                                 may permit further replies by both                      these documents available to the parties              U.S.C. 233 pursuant to this section shall
                                                 parties.                                                and the Secretary.                                    be distributed in the same manner as
                                                                                                                                                               provided in § 15.19.
                                                                                                         § 15.17   Final agency determination.
                                                 § 15.15   Discovery.
                                                                                                           (a) In hearings conducted under                     § 15.19 Effective date of a final agency
                                                    (a) At any time after the initiation of              § 15.14, the adjudicating official shall              determination.
                                                 the proceeding, the administrative law                  make the final agency determination, on                  (a) A final agency determination
                                                 judge may order, by subpoena if                         the basis of the record, findings,                    under § 15.17 that an individual shall
                                                 necessary, the taking of a deposition and               conclusions, and recommendations                      not be deemed to be an employee of the
                                                 the production of relevant documents                    presented by the administrative law                   Public Health Service for purposes of 42
                                                 by the deponent. Such order may be                      judge.                                                U.S.C. 233 shall be provided to the
                                                 entered upon a showing that the                           (b) Prior to making a final agency                  Department of Health and Human
                                                 deposition is necessary for discovery                   determination, the adjudicating official              Services and sent by certified or
                                                 purposes, and that such discovery could                 shall give the parties an opportunity to              registered mail to the individual and to
                                                 not be accomplished by voluntary                        submit the following, within thirty (30)              the entity employing such individual if
                                                 methods. Such an order may also be                      days after the submission of the                      the individual is currently an officer,
                                                 entered in extraordinary circumstances                  administrative law judge’s                            employee, or contractor of an entity
                                                 to preserve relevant evidence upon a                    recommendations:                                      described in 42 U.S.C. 233(g)(4). In the
                                                                                                           (1) Proposed findings and                           event the individual is no longer an
                                                 showing that there is substantial reason
                                                                                                         determinations;                                       officer, employee, or contractor of such
                                                 to believe that such evidence could not                   (2) Exceptions to the
                                                 be presented through a witness at the                                                                         an entity, the determination shall be
                                                                                                         recommendations of the administrative                 sent by certified or registered mail to the
                                                 hearing. The decisive factors for a                     law judge;
                                                 determination under this subsection,                                                                          individual and to the last entity
                                                                                                           (3) Supporting reasons for the                      described in 42 U.S.C. 233(g)(4) at
                                                 however, shall be fairness to all parties               exceptions or proposed findings or
                                                 and the requirements of due process. A                                                                        which such individual was an officer,
                                                                                                         determinations; and                                   employee, or contractor.
                                                 deposition may be taken orally or upon                    (4) Final briefs summarizing the
                                                 written questions before any person                                                                              (b) A final agency determination shall
                                                                                                         arguments presented at the hearing.
                                                                                                           (c) All determinations made by the                  be effective upon the date the written
                                                 who has the power to administer oaths
                                                                                                         adjudicating official under this rule                 determination is received by such
                                                 and shall not exceed one day of seven
                                                                                                         shall constitute final agency actions.                entity.
                                                 hours.
                                                                                                         After a final agency determination                       (c) An adverse final agency
                                                    (b) Each deponent shall be duly                                                                            determination shall apply to all acts or
                                                 sworn, and any adverse party shall have                 under this rule that an individual shall
                                                                                                         not be deemed to be an employee of the                omissions of the individual occurring
                                                 the right to cross-examine. Objections to                                                                     after the date the adverse final
                                                                                                         Public Health Service, such individual
                                                 questions or documents shall be in short                                                                      determination is received by such
                                                                                                         will be deemed not to be an employee
                                                 form, stating the grounds upon which                                                                          entity.
                                                                                                         of the Public Health Service except
                                                 objections are made. The questions                      pursuant to § 15.20.                                     (d) The Attorney General will inform
                                                 propounded and the answers thereto,                                                                           the National Practitioner Data Bank of
                                                 together with all objections made (but                  § 15.18   Rehearing.                                  any final agency determination under
                                                 not including argument or debate), shall                   (a) An individual dissatisfied with a              § 15.17 that an individual shall not be
                                                 be reduced to writing and certified by                  final agency determination under                      deemed to be an employee of the Public
                                                 the person before whom the deposition                   § 15.17 may, within 30 days after the                 Health Service for purposes of 42 U.S.C.
                                                 was taken. Thereafter, the person taking                notice of the final agency determination              233.
                                                 the deposition shall forward the                        is sent, request the adjudicating official
                                                                                                                                                               § 15.20    Reinstatement.
                                                 deposition and one (1) copy thereof to                  to re-review the record, and may present
                                                 the party at whose instance the                         additional evidence that is appropriate                  (a) No less than five years after the
                                                 deposition was taken and shall forward                  and pertinent to support a different                  time for rehearing has expired, and no
                                                 one (1) copy to the representative of the               decision.                                             more often than every five years, an
                                                                                                            (b) The adjudicating official may                  individual who has been the subject of
                                                 other party.
                                                                                                         require that another oral hearing be held             a final agency determination under
                                                    (c) A deposition may be admitted into                on one or more of the issues in                       § 15.17 may petition the Attorney
                                                 evidence as against any party who was                   controversy, or permit the dissatisfied               General for reconsideration of that
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                                                 present or represented at the taking of                 party to present further evidence or                  determination and reinstatement. The
                                                 the deposition, or who had due notice                   argument in writing, if the adjudicating              individual bears the burden of proof and
                                                 thereof, if the administrative law judge                official finds that the individual has:               persuasion.
                                                 finds that there are sufficient reasons for                (1) Presented evidence or argument                    (b) In support of the petition for
                                                 admission and that the admission of the                 that is sufficiently significant to require           reinstatement, the individual shall
                                                 evidence would be fair to all parties and               the conduct of further proceedings; or                submit relevant evidence relating to the
                                                 comport with the requirements of due                       (2) Shown some defect in the conduct               period since the original proceedings
                                                 process.                                                of the adjudication under this subpart                under this subpart and a statement


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                                                                           Federal Register / Vol. 80, No. 44 / Friday, March 6, 2015 / Proposed Rules                                             12109

                                                 demonstrating that treating the                         ENVIRONMENTAL PROTECTION                              the comment includes information
                                                 individual as an employee of the Public                 AGENCY                                                claimed to be Confidential Business
                                                 Health Service for purposes of 42 U.S.C.                                                                      Information (CBI) or other information
                                                 233(g) would no longer expose the                       40 CFR Part 52                                        whose disclosure is restricted by statute.
                                                 United States to an unreasonably high                   [EPA–R07–OAR–2014–0528; FRL–9924–04-                  Do not submit through http://
                                                 degree of risk of loss.                                 Region 7]                                             www.regulations.gov or email
                                                                                                                                                               information that you consider to be CBI
                                                    (c) Upon receiving a petition for                                                                          or otherwise protected. The http://
                                                                                                         Approval and Promulgation of
                                                 reinstatement, the initiating official                                                                        www.regulations.gov Web site is an
                                                                                                         Implementation Plans; State of
                                                 shall determine, in the initiating                      Kansas; Infrastructure SIP                            ‘‘anonymous access’’ system, which
                                                 official’s unreviewable discretion,                     Requirements for the 2010 Sulfur                      means EPA will not know your identity
                                                 whether the petition makes a prima                      Dioxide National Ambient Air Quality                  or contact information unless you
                                                 facie case that no longer would expose                  Standard                                              provide it in the body of your comment.
                                                 the United States to an unreasonably                                                                          If you send an email comment directly
                                                 high degree of risk of loss. The initiating             AGENCY:  Environmental Protection                     to EPA without going through http://
                                                 official’s determination that a petition                Agency.                                               www.regulations.gov, your email
                                                 does not make a prima facie case is not                 ACTION: Proposed rule.                                address will be automatically captured
                                                 subject to further review.                                                                                    and included as part of the comment
                                                                                                         SUMMARY:    The Environmental Protection
                                                    (d) Upon a prima facie case having                                                                         that is placed in the public docket and
                                                                                                         Agency (EPA) is proposing to approve
                                                 been made, an administrative law judge                                                                        made available on the Internet. If you
                                                                                                         elements of a State Implementation Plan
                                                                                                                                                               submit an electronic comment, EPA
                                                 shall be appointed in accordance with 5                 (SIP) submission from the State of
                                                                                                                                                               recommends that you include your
                                                 U.S.C. 3105 and shall conduct such                      Kansas addressing the applicable
                                                                                                                                                               name and other contact information in
                                                 proceedings pursuant to §§ 15.13                        requirements of Clean Air Act (CAA)
                                                                                                                                                               the body of your comment and with any
                                                 through 15.16 as the administrative law                 section 110 for the 2010 National
                                                                                                                                                               disk or CD–ROM you submit. If EPA
                                                 judge deems necessary, in his or her                    Ambient Air Quality Standards
                                                                                                                                                               cannot read your comment due to
                                                 sole discretion, to determine whether                   (NAAQS) for Sulfur Dioxide (SO2),
                                                                                                                                                               technical difficulties and cannot contact
                                                 the individual has established that                     which requires that each state adopt and
                                                                                                                                                               you for clarification, EPA may not be
                                                 treating the individual as an employee                  submit a SIP to support implementation,
                                                                                                                                                               able to consider your comment.
                                                 of the Public Health Service for                        maintenance, and enforcement of each
                                                                                                                                                               Electronic files should avoid the use of
                                                 purposes of 42 U.S.C. 233(g) would no                   new or revised NAAQS promulgated by
                                                                                                                                                               special characters, any form of
                                                 longer expose the United States to an                   EPA. These SIPs are commonly referred
                                                                                                                                                               encryption, and should be free of any
                                                 unreasonably high degree of risk of loss,               to as ‘‘infrastructure’’ SIPs. The
                                                                                                                                                               defects or viruses.
                                                                                                         infrastructure requirements are designed                 Docket: All documents in the
                                                 and shall submit written findings of
                                                                                                         to ensure that the structural components              electronic docket are listed in the http://
                                                 fact, conclusions of law, and a
                                                                                                         of each state’s air quality management                www.regulations.gov index. Although
                                                 recommended decision to the                             program are adequate to meet the state’s
                                                 adjudicating official pursuant to § 15.16.                                                                    listed in the index, some information is
                                                                                                         responsibilities under the CAA.                       not publicly available, i.e., CBI or other
                                                    (e) On a petition for reinstatement, the             DATES: Comments must be received on                   information whose disclosure is
                                                 adjudicating official shall make the final              or before April 6, 2015.                              restricted by statute. Certain other
                                                 agency determination, on the basis of                   ADDRESSES: Submit your comments,                      material, such as copyrighted material,
                                                 the record, findings, conclusions, and                  identified by Docket ID No. EPA–R07–                  will be publicly available only in hard
                                                 recommendations presented by the                        OAR–2014–0528, by one of the                          copy. Publicly available docket
                                                 administrative law judge, which shall                   following methods:                                    materials are available either
                                                 include the record from the original                      1. http://www.regulations.gov. Follow               electronically at http://
                                                 determination and any petition for                      the on-line instructions for submitting               www.regulations.gov or in hard copy at
                                                 rehearing. All determinations made by                   comments.                                             U.S. Environmental Protection Agency,
                                                 the adjudicating official under this rule                 2. Email: kemp.lachala@epa.gov.                     Region 7, 11201 Renner Boulevard,
                                                 shall constitute final agency actions.                    3. Mail: Ms. Lachala Kemp, Air                      Lenexa, Kansas 66219 from 8:00 a.m. to
                                                                                                         Planning and Development Branch, U.S.                 4:30 p.m., Monday through Friday,
                                                    (f) A determination that an individual               Environmental Protection Agency,
                                                 is reinstated pursuant to this section                                                                        excluding legal holidays. The interested
                                                                                                         Region 7, Air and Waste Management                    persons wanting to examine these
                                                 shall be distributed in the same manner                 Division, 11201 Renner Boulevard,
                                                 as provided in § 15.19.                                                                                       documents should make an
                                                                                                         Lenexa, Kansas 66219.                                 appointment with the office at least 24
                                                   Dated: February 25, 2015.                               4. Hand Delivery or Courier: Deliver
                                                                                                                                                               hours in advance.
                                                 Eric H. Holder, Jr.,                                    your comments to Ms. Lachala Kemp,
                                                                                                                                                               FOR FURTHER INFORMATION CONTACT: Ms.
                                                                                                         Air Planning and Development Branch,
                                                 Attorney General.
                                                                                                         U.S. Environmental Protection Agency,                 Lachala Kemp, Air Planning and
                                                 [FR Doc. 2015–05027 Filed 3–5–15; 8:45 am]              Region 7, Air and Waste Management                    Development Branch, U.S.
                                                 BILLING CODE 4410–12–P                                  Division, 11201 Renner Boulevard,                     Environmental Protection Agency,
                                                                                                         Lenexa, Kansas 66219.                                 Region 7, 11201 Renner Boulevard,
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                                                                                                           Instructions: Direct your comments to               Lenexa, KS 66219; telephone number:
                                                                                                         Docket ID No. EPA–R07–OAR–2014–                       (913) 551–7214; fax number: (913) 551–
                                                                                                         0528. EPA’s policy is that all comments               7065; email address: kemp.lachala@
                                                                                                         received will be included in the public               epa.gov.
                                                                                                         docket without change and may be                      SUPPLEMENTARY INFORMATION:
                                                                                                         made available online at http://                      Throughout this document whenever
                                                                                                         www.regulations.gov, including any                    ‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we refer
                                                                                                         personal information provided, unless                 to EPA. This section provides additional


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Document Created: 2018-02-21 09:33:05
Document Modified: 2018-02-21 09:33:05
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesWritten comments must be postmarked on or before May 5, 2015, and electronic comments must be sent on or before midnight Eastern time May 5, 2015.
ContactJames G. Touhey, Jr., Director, Torts Branch, Civil Division, Department of Justice, Washington, DC 20530, (202) 616-4400.
FR Citation80 FR 12104 
RIN Number1105-AB37
CFR AssociatedClaims; Government Contracts; Government Employees; Health Care; Immunization and Nuclear Energy

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