Procedures for Designating Classes of Employees as Members of the Special Exposure Cohort Under the Energy Employees Occupational Illness Compensation Program Act of 2000; Amendments, 37455-37459 [E7-13233]
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Federal Register / Vol. 72, No. 131 / Tuesday, July 10, 2007 / Rules and Regulations
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[FR Doc. 07–3332 Filed 7–9–07; 8:45 am]
BILLING CODE 7710–12–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 83
RIN 0920–AA13
Procedures for Designating Classes of
Employees as Members of the Special
Exposure Cohort Under the Energy
Employees Occupational Illness
Compensation Program Act of 2000;
Amendments
Department of Health and
Human Services.
ACTION: Final Rule.
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AGENCY:
SUMMARY: The Department of Health and
Human Services is amending its
procedures for designating classes of
employees to be added to the Special
Exposure Cohort under the Energy
Employees Occupational Illness
Compensation Program Act of 2000
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(EEOICPA). The final rule adds and
revises deadlines for evaluating
petitions for cohort status, clarifies
when time periods commence and how
they toll, and provides information
relevant to these deadlines on the
content of petition evaluation reports.
DATES: This Final Rule is effective July
10, 2007.
FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, 4676 Columbia
Parkway, MS–C–46, Cincinnati, OH
45226, Telephone 513–533–6825 (this is
not a toll free number). Information
requests can also be submitted by e-mail
to OCAS@CDC.GOV.
SUPPLEMENTARY INFORMATION:
I. Purpose of Rulemaking
On October 28, 2004, the President
signed the Ronald W. Reagan National
Defense Authorization Act for Fiscal
Year 2005, Pub. L. 108–375 (codified as
amended in scattered sections of 42
U.S.C.). Division C, Subtitle E, of this
Act includes amendments to the Energy
Employees Occupational Illness
Compensation Program Act of 2000
(‘‘EEOICPA’’), 42 U.S.C. 7384–7385.
Several of these amendments, under
§ 3166(b), established new statutory
requirements under 42 U.S.C. 7384q and
7384l(14)(C)(ii) that pertain to the
Department of Health and Human
Services (‘‘HHS’’) procedures
established under 42 CFR part 83:
‘‘Procedures for Designating Classes of
Employees as Members of the Special
Exposure Cohort under the Energy
Employees Occupational Illness
Compensation Program Act of 2000.’’
These new requirements included the
following: (1) Following the receipt of a
petition for designation as members of
the Special Exposure Cohort (‘‘the
Cohort’’), the National Institute for
Occupational Safety and Health
(NIOSH) must submit ‘‘a
recommendation’’ on that petition,
including all documentation, to the
Advisory Board on Radiation and
Worker Health (‘‘the Board’’) within 180
days; (2) following the receipt by the
Secretary of HHS (‘‘the Secretary’’) of a
recommendation by the Board that the
Secretary determine in the affirmative
that a class meets the statutory criteria
for addition to the Cohort, the Secretary
must submit to Congress a
determination as to whether or not the
class meets these statutory criteria
within 30 days; (3) if the Secretary does
not submit this determination to
Congress within 30 days, then on the
31st day it shall be deemed that the
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37455
Secretary has submitted a report to
Congress that designates, as an addition
to the Cohort, the class recommended
by the Board for addition to the Cohort
and that provides the criteria used to
support the designation; and (4) the
period Congress shall have to review a
report submitted by the Secretary to
designate a class as an addition to the
Cohort is reduced from 180 days to 30
days.
The purpose of the new requirements
was to expedite the evaluation and
decision process for adding classes of
employees to the Cohort.
On December 22, 2005, HHS issued
an Interim Final Rule (IFR)
incorporating changes to ensure the new
statutory requirements are met and
requesting public comment (70 FR
75950). The public comment period for
this rulemaking was initially to close on
February 21, 2006. Upon a request from
the Board for additional time to
comment, the comment period was
extended for 30 days and closed on
March 23, 2006, after a total of 90 days.
As discussed below, HHS has
incorporated additional changes in this
Final Rule in response to comments
from the Board and from the public.
These changes also bring the Final Rule
into alignment with the Congressional
recommendations specified in the
Conference Report associated with the
new statutory deadlines (H. Rep. 108–
767).
II. Summary of Public Comments
The public comment period for the
IFR extended from December 22, 2005
through March 23, 2006. HHS received
comments from seven parties in
addition to the consensus comments of
the Board. These include four
individuals, one U.S. Senator, one labor
organization, and one advocacy group.
The comments are summarized and
responded to below, together with
explanations of changes HHS has
incorporated into this Final Rule.
A. 180-Day Deadline for NIOSH
Recommendations
Several commenters, including the
Board, recommended that HHS reiterate
in the final rule NIOSH’s 180-day
statutory deadline to evaluate a petition
and submit recommendations to the
Board. One commenter also wanted the
rule to specify what actions HHS would
take if NIOSH failed to meet that
deadline. In contrast, another
commenter recommended against
including any of the statutory deadlines
in the rule because of concern that
hastening the evaluation and
recommendation process could prevent
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the full and fair consideration of
petitions.
Commenters also raised concerns
about various aspects of the IFR’s
petition qualification and review
process. Several commenters were
concerned that the rule did not include
within the 180-day statutory deadline
NIOSH’s process for identifying
deficiencies in petitions. They said the
FY05 Defense Act Conference Report
(H.Rep. 108–767) indicated that
Congress intended for the qualification
process to be included within the 180day period, citing the following from the
Report:
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During the 180 day period when NIOSH is
preparing the petition for review by the
Advisory Board, NIOSH should identify all
deficiencies in the petition * * *
Most commenters, including the
Board, also recommended that HHS
reinstate the 30-day period for
petitioners to request a review of
NIOSH’s proposed finding that a
petition is deficient and does not qualify
for consideration. Finally, one
commenter recommended that HHS
clarify in the rule that NIOSH will
provide a recommendation for each
class of employees the petition covers.
In response to those comments, HHS
has made several changes in the final
rule. First, HHS has added a reference
to the 180-day deadline for NIOSH to
evaluate petitions and submit
recommendations to the Board (§ 83.13
(e)). The provisions in the IFR were
designed to ensure that NIOSH would
meet the deadline. Referencing the 180day deadline in the final rule identifies
the goal that the earlier changes are
intended to achieve.
Second, HHS has revised the rule so
the process of determining whether
petitions are qualified is included in the
180-day period (§§ 83.5(k) and 83.11).
HHS agrees with the commenters that
Congress intended to include that
process in the 180-day period, and the
change brings the final rule into
alignment with the Conference Report.
As the commenters pointed out, the
IFR did not include this process in the
180-day period. In the preamble to the
IFR, HHS said it was necessary to
exclude the process from the deadline to
ensure that NIOSH had adequate time to
evaluate petitions and make
recommendations within the deadline.
According to NIOSH, sometimes it can
take months to assist and consult with
petitioners to help them remedy petition
deficiencies, which could significantly
impact NIOSH’s ability to do a
comprehensive evaluation before the
deadline ended. Thus, in the IFR HHS
distinguished between ‘‘submissions’’
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(i.e., petitions that were not yet
determined to meet the requirements of
§§ 83.7–83.9) and ‘‘petitions’’ (i.e.,
petitions that have been determined to
meet the requirements) (§ 83.5(k)). The
180-day period started tolling only
when NIOSH received a ‘‘petition’’
(§ 83.5(k)). In the final rule, HHS has
deleted § 83.5(k) and removed the
distinction between submissions and
petitions in § 83.11.
Third, HHS has reinstated the 30-day
period for petitioners to request a
review of NIOSH’s proposed finding
that a petition is deficient (§ 83.11). In
the IFR, HHS had reduced the request
period to 7 days to increase the
feasibility of NIOSH meeting the 180day deadline. To ensure that the
additional time for requesting review
does not prevent NIOSH from meeting
the deadline, HHS is adopting the
recommendation of one commenter that
the clock on the 180 days start when
petitioners seek and are granted a
review on whether their petition
satisfies all requirements. Accordingly,
HHS has added new paragraph (e) to
§ 83.13 specifying that the 180-day
period shall not include any days
during which (1) the petitioner is
revising the petition to remedy
deficiencies NIOSH identified, (2) the
petitioner requests a review of NIOSH’s
proposed finding that the petition does
not meet all relevant requirements, or
(3) the three-person HHS panel (as
authorized by § 83.11(d)) is reviewing
the petitioner’s request.
Finally, HHS has revised § 83.13(d)(4)
to clarify that NIOSH evaluation report
findings to the Board must specify
whether it is ‘‘feasible’’ to estimate
radiation doses with sufficient accuracy
‘‘for each class defined in the report.’’
HHS is adding this specification
because NIOSH sometimes finds a
Cohort petition covers more than one
class of employees even though it is
submitted on behalf of a single class.
For example, in some cases, NIOSH will
find differences in radiation exposures
and record availability for different
employee groups at the same facility.
Consequently, NIOSH evaluation
reports may need to define more than
one class of employees in the petition
and provide separate findings
concerning each class. In light of
NIOSH’s 180-day deadline, HHS has
also added language to paragraph (d)(4)
indicating that NIOSH’s evaluation
report must include a feasibility finding
about whether radiation doses for each
class of employees can be estimated
with sufficient accuracy.
HHS did not adopt every
recommendation commenters made.
HHS has not incorporated
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recommendations that NIOSH inform
petitioners of all deficiencies within the
first 30 days (H. Rep. 108–767). HHS
believes the recommendation is not
necessary. The changes in the final rule
specifying that the 180-day period
begins when NIOSH receives a petition
gives the Agency more than adequate
incentive to identify very quickly
whether the petition qualifies for
consideration or has deficiencies.
Also, HHS has not adopted the
recommendation to add requirements to
the final rule specifying the actions HHS
would take if NIOSH failed to meet the
180-day deadline. HHS fully
understands the EEOICPA statutory
amendments stressing the importance of
evaluating petitions in a timely manner.
Although there may be complex
circumstances of radiation exposure or
records availability or exceptional
instances when it may be challenging to
complete a comprehensive evaluation
covering all of the classes of employees
included in petition within 180 days,
HHS will make every effort to meet the
deadline. The NIOSH Web page at
http:www.cdc.gov/NIOSH/ocas will
continuously track the progress of each
active petition for the interested public.
B. Resubmission of Petitions Based on
New Information
Two commenters indicated confusion
concerning whether a petitioner could
submit a petition on behalf of a class of
employees subsequent to NIOSH finding
that a prior petition covering the class
did not meet the petition requirements.
The commenters believed that § 83.11(f)
only permitted NIOSH, upon its own
discretion, to consider a petition for a
class of employees for which a prior
petition had already been found to not
meet petition requirements.
Nothing in the rule would prevent a
petitioner from submitting a subsequent
petition based on new information.
Such a petition would be evaluated by
NIOSH as a new petition. HHS has
amended § 83.11, adding paragraph (g),
to clarify that petitioners may submit an
additional petition for a class of
employees, based on new information,
subsequent to NIOSH finding that a
petition does not meet the petition
requirements specified in §§ 83.7—83.9.
The existing paragraph (f) of § 83.11
has a different purpose. It is intended to
allow NIOSH to reconsider a petition
that it found to not meet petition
requirements, based on new information
NIOSH might obtain from any source,
irrespective of any further action of the
petitioner.
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C. Deadline for the Chair of the Board
To Submit the Cohort Petition
Recommendations of the Board
One commenter recommended that
HHS regulate the current policy of the
Board that requires the Chair to submit
recommendations of the Board on the
outcome of Cohort petitions to the
Secretary within 21 days of the Board’s
consensus formulation and approval of
the recommendations.
HHS has not incorporated this Board
policy into the rule. Doing so would
violate the Administrative Procedure
Act (‘‘APA’’) rulemaking procedures
specified in 5 U.S.C. 553 for the
development of regulations. The APA
requires that the regulating agency both
provide the public with the opportunity
for notice and comment and consider
submitted comments prior to
promulgation of a final rule. The change
proposed by the commenter is not a
reasonably foreseeable outcome of the
changes discussed in the IFR and
making such a change would not offer
the public adequate notice of the
change.
Furthermore, HHS does not consider
it necessary or appropriate to regulate
this currently self-imposed policy of the
Board. It is within the Board’s
prerogative, with the guidance of the
Designated Federal Official, to set and
manage its own deadlines.
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D. Review of Proposed and Final
Decisions of HHS on the Outcome of
Cohort Petitions
One commenter recommended HHS
reinstate the opportunity for petitioners
to seek reviews of the proposed
decisions on the outcome of petitions,
issued by the Director of NIOSH under
§ 83.16(a), prior to the issuance of final
decisions by the Secretary of HHS.
As discussed in the preamble of the
IFR (70 FR 75950, December 22, 2005),
it is not possible for petitioners to seek
and HHS to provide an administrative
review of the proposed decision, and for
the Secretary to issue a final decision,
all within the 30-day Congressional
report deadline. For this reason, the
administrative review opportunity of
petitioners was preserved but moved in
the sequence of HHS actions to follow,
rather than precede, the Secretary’s final
decision.
Another commenter questioned
whether the Secretary has discretion in
responding to an HHS administrative
review of a final decision and whether
petitioners must seek such an
administrative review as a prerequisite
to obtaining a judicial review of a final
decision of the Secretary issued under
§ 83.17.
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Under § 83.18(c), the Secretary retains
the discretion to decide the outcome of
a petition, after obtaining and
considering the information provided by
the HHS administrative review. The
authority to decide the outcome of
petitions was statutorily assigned to the
President (42 U.S.C. 7384q) and
delegated to the Secretary by Executive
Order 13179.
The Secretary’s decision to add or
deny adding a class to the Cohort is
final unless he revises the decision
pursuant to an administrative review
under § 83.18 or Congress takes other
action. This administrative review is
optional; neither EEOICPA nor this
regulation requires it as a prerequisite to
judicial review.
E. Protection of the Personal
Information of the Petitioner
One commenter recommended
requiring that NIOSH disclose the
identities and contact information of
petitioners. The commenter reasoned
that since the petitioner is acting on
behalf of a class of employees, the
petitioner should not have the right to
privacy.
The IFR did not propose imposing
such a requirement on NIOSH or
petitioners in this Final Rule. Instead,
HHS would first have to provide public
notice, the opportunity for public
comment, and consideration of
comments submitted, as required for
rulemaking under the APA.
Moreover, the recommendation to
require petitioners or NIOSH to disclose
the identity and contact information of
the petitioners is contrary to the
customary protection afforded by the
Federal government to members of the
public under the Privacy Act (5 U.S.C.
552a). In particular, 5 U.S.C. 552a(b)
bars agencies (subject to certain
exceptions not applicable here) from
disclosing records such as those at issue
in the recommendation, where
petitioner information is ‘‘contained in
a system of records’’ that allows
retrieval of such records by unique
person-specific identifiers, ‘‘to any
person, or to another agency’’ without
the individual’s written request or prior
written consent.
In addition, there does not appear to
be a substantial justification or benefit
to requiring the disclosure of the
identity and contact information of the
petitioner. A petitioner should not have
to choose between acting on his or her
own behalf, as a member or a survivor
of a member of the class of employees
represented in the petition, and his or
her right to privacy. It is true that the
class of employees includes other
individuals who would also benefit
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37457
from an affirmative decision on the
petition by the Secretary, but any other
member of the class of employees
covered by the petition can obtain the
same rights as the petitioner by
submitting a valid petition, meeting the
requirements specified under §§ 83.7–
83.9, on behalf of the same class of
employees.
F. Authority and Deadline for the
Secretary To Decide on Petitions
Two commenters appeared to have
misunderstood the statutory
requirement that the President render a
decision regarding the addition of a
class of employees to the Cohort within
30 days of the Board having
recommended its addition (see 42
U.S.C. 7384q(c)(2)(A)–(B)) to newly
authorize the President’s involvement in
these decisions. One commenter
recommended that the President not be
given the role of making such decisions,
and the second commenter
recommended that the President not be
provided 30 days to make such
decisions, as the commenter believed
this would prolong the decision-making
process.
Since EEOICPA was originally
enacted in 2000, the President has been
solely authorized in the statute to
decide whether or not to designate
classes of employees for addition to the
Cohort. The President delegated this
authority to the Secretary, who has
implemented this authority ever since.
The only change made by the statutory
requirement discussed above is to
impose a 30-day deadline on the
President to make such decisions in
certain cases. As discussed in the IFR,
this 30-day deadline applies to the
Secretary’s decisions, since the
President delegated this decisionmaking authority to the Secretary. The
deadline does not prolong the decisionmaking process since, prior to this
statutory requirement, the Secretary was
not under any deadline to make such
decisions.
G. Non-Regulatory Comments
HHS received several comments that
do not pertain to the IFR. These
included a comment to add a class of
employees from the Hanford facility to
the Cohort, a personal perspective on
the history of the management of the
U.S. nuclear weapons program,
concerns about the involvement of the
Office of Management and Budget
(‘‘OMB’’) in the program, and a
speculation that adding classes of
employees to the Cohort would be costsaving compared to the conduct of dose
reconstructions.
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The Board recommended NIOSH
provide petitioners with guidance in the
form of a timeline for the petition
process, to ensure petitioners
understand the expected duration of the
entire process and its elements, from the
submission of a petition to the point at
which final decisions on a petition
become effective. NIOSH will provide
each petitioner with such guidance,
together with other introductory
materials provided to petitioners upon
the receipt by NIOSH of a petition.
One commenter suggested all cancers
be added to the list of 22 ‘‘specified
cancers’’ covered for members of the
Cohort. The list of specified cancers
covered for members of the Cohort is
established statutorily under EEOICPA
and not governed by this rulemaking.
EEOICPA states:
The term ‘‘specified cancer’’ means
any of the following:
(A) A specified disease, as that term
is defined in section 4(b)(2) of the
Radiation Exposure Compensation Act
(42 U.S.C. 2210 note).
(B) Bone cancer.
(C) Renal cancers.
(D) Leukemia (other than chronic
lymphocytic leukemia), if initial
occupational exposure occurred before
21 years of age and onset occurred more
than two years after initial occupational
exposure. 42 U.S.C. 7384l(17)
III. Regulatory Assessment
Requirements
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A. Executive Order 12866
Under Executive Order 12866 (58 FR
51735, October 4, 1993), the agency
must determine whether a regulatory
action is ‘‘significant’’ and therefore
subject to review by OMB and the
requirements of the Executive Order.
Under section 3(f), the order defines a
‘‘significant regulatory action’’ as an
action that is likely to result in a rule
(1) having an annual effect on the
economy of $100 million or more, or
adversely and materially affecting a
sector of the economy, productivity,
competition, jobs, the environment,
public health or safety, or State, local,
or tribal governments or communities
(also referred to as ‘‘economically
significant’’); (2) creating serious
inconsistency or otherwise interfering
with an action taken or planned by
another agency; (3) materially altering
the budgetary impacts of entitlements,
grants, user fees, or loan programs or the
rights and obligations of recipients
thereof; or (4) raising novel legal or
policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in the executive
order.
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This rule is being treated as a
‘‘significant regulatory action’’ within
the meaning of the executive order
because it meets the criterion of Section
3(f)(4) in that it raises novel or legal
policy issues arising out of the legal
mandate established by EEOICPA. It
amends current procedures by which
the Secretary considers petitions to add
classes of employees to the Cohort to
comport with new statutory deadlines
(see 42 U.S.C. 7384q(c)(2)(A) and 42
U.S.C. 7384l(14)(C)(ii)). The revisions,
however, neither affect the financial
cost to the federal government of
responding to these petitions nor the
scientific and policy bases for making
decisions on such petitions.
The rule carefully explains the
manner in which the procedures are
consistent with the mandates of 42
U.S.C. 7384q and 7384l(14)(C)(ii) and
implements the detailed requirements of
these sections. The rule does not
interfere with State, local, and tribal
governments in the exercise of their
governmental functions.
The rule is not considered
economically significant, as defined in
§ 3(f)(1) of Executive Order 12866. As
discussed above, it does not affect the
financial cost to the federal government
of responding to these petitions nor
does it affect the scientific and policy
bases for making decisions on such
petitions. Furthermore, it has a
subordinate role in the adjudication of
claims under EEOICPA, serving as one
element of an adjudication process
administered by the Department of
Labor (‘‘DOL’’) under 20 CFR parts 1
and 30. DOL has determined that its
rule fulfills the requirements of
Executive Order 12866 and provides
estimates of the aggregate cost of
benefits and administrative expenses of
implementing EEOICPA under its rule
(see 71 FR 78520, December 29, 2006).
OMB has reviewed this rule for
consistency with the President’s
priorities and the principles set forth in
Executive Order 12866.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act
(‘‘RFA’’), 5 U.S.C. 601 et. seq., requires
each agency to consider the potential
impact of its regulations on small
entities, including small businesses,
small governmental units, and small
not-for-profit organizations. HHS
certifies that this rule will not have a
significant economic impact on a
substantial number of small entities
within the meaning of the RFA. The rule
affects only HHS, DOL, the Department
of Energy, and certain individuals
covered by EEOICPA. Therefore, a
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regulatory flexibility analysis as
provided for under RFA is not required.
C. What Are the Paperwork and Other
Information Collection Requirements
(Subject to the Paperwork Reduction
Act) Imposed Under This Rule?
The Paperwork Reduction Act
(‘‘PRA’’) 44 U.S.C. 3501 et seq., requires
an agency to invite public comment on
and to obtain OMB approval of any
regulation that requires ten or more
people to report information to the
agency or to keep certain records. The
Special Exposure Cohort rule, 42 CFR
part 83, which requires the collection of
information from petitioners, is covered
by the PRA and has received OMB
clearance (OMB control #0920–0639).
However, this rulemaking, which makes
limited changes to 42 CFR part 83, does
not contain any information collection
requirements. Thus, HHS has
determined that the PRA does not apply
to this rulemaking.
D. Small Business Regulatory
Enforcement Fairness Act
As required by Congress under the
Small Business Regulatory Enforcement
Fairness Act of 1996 (5 U.S.C. 801 et
seq.), HHS will report to Congress
promulgation of this rule prior to its
taking effect. The report will state that
HHS has concluded that this rule is not
a ‘‘major rule’’ because it is not likely
to result in an annual effect on the
economy of $100 million or more.
However, this rule has a subordinate
role in the adjudication of claims under
EEOICPA, serving as one element of an
adjudication process administered by
DOL under 20 CFR parts 1 and 30. DOL
has determined that its rule is a ‘‘major
rule’’ because it will likely result in an
annual effect on the economy of $100
million or more.
E. Unfunded Mandates Reform Act of
1995
Title II of the Unfunded Mandates
Reform Act of 1995 (2 U.S.C. 1531 et
seq.) directs agencies to assess the
effects of federal regulatory actions on
State, local, and tribal governments and
the private sector ‘‘other than to the
extent that such regulations incorporate
requirements specifically set forth in
law.’’ For purposes of the Unfunded
Mandates Reform Act, this rule does not
include any federal mandate that may
result in increased annual expenditures
in excess of $100 million by state, local
or tribal governments in the aggregate,
or by the private sector.
F. Executive Order 12988 (Civil Justice)
This rule has been drafted and
reviewed in accordance with Executive
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Federal Register / Vol. 72, No. 131 / Tuesday, July 10, 2007 / Rules and Regulations
Order 12988 on Civil Justice Reform and
will not unduly burden the federal court
system. HHS adverse decisions may be
reviewed in United States District
Courts pursuant to the APA. HHS has
attempted to minimize that burden by
providing petitioners an opportunity to
seek administrative review of adverse
decisions. HHS has provided a clear
legal standard it will apply in
considering petitions. This rule has
been reviewed carefully to eliminate
drafting errors and ambiguities.
G. Executive Order 13132 (Federalism)
HHS has reviewed this rule in
accordance with Executive Order 13132
regarding federalism, and has
determined that it does not have
‘‘federalism implications.’’ The rule
does 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.’’
H. Executive Order 13045 (Protection of
Children From Environmental, Health
Risks and Safety Risks)
In accordance with Executive Order
13045, HHS has evaluated the
environmental health and safety effects
of this rule on children. HHS has
determined that the rule would have no
effect on children.
I. Executive Order 13211 (Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use)
In accordance with Executive Order
13211, HHS has evaluated the effects of
this rule on energy supply, distribution
or use, and has determined that the rule
will not have a significant adverse effect
on them.
rmajette on PROD1PC64 with RULES
J. Effective Date
The Secretary has determined,
pursuant to 5 U.S.C. 553(d)(3), that there
is good cause for this rule to be effective
immediately to eliminate legal
inconsistencies between new statutory
requirements under 42 U.S.C. 7384l and
7384q and regulatory requirements
under 42 CFR part 83 and to make the
implementation of the new statutory
requirements feasible.
List of Subjects in 42 CFR Part 83
Government employees, Occupational
safety and health, Nuclear materials,
Radiation protection, Radioactive
materials, Workers’ compensation.
Text of the Rule
For the reasons discussed in the
preamble, the interim rule amending 42
I
VerDate Aug<31>2005
15:13 Jul 09, 2007
Jkt 211001
CFR part 83, published on December 22,
2005 (70 FR 75950), is confirmed as
final with the folling changes:
PART 83—[AMENDED]
1. The authority citation for part 83
continues to read as follows:
I
Authority: 42 U.S.C. 7384q; E.O. 13179, 65
FR 77487, 3 CFR, 2000 Comp., p. 321.
Subpart B—Definitions
§ 83.5
[Amended]
2. Amend § 83.5 by removing
paragraph (k) and redesignating
paragraphs (l) through (p) as paragraphs
(k) through (o), respectively.
I
Subpart C—Procedures for Adding
Classes of Employees to the Cohort
3. Amend § 83.11 as follows:
A. By revising the section heading.
B. By replacing the term ‘‘submission’’
with the term ‘‘petition’’ in paragraphs
(a) through (d) and (f).
I C. By replacing the phrases ‘‘7
calendar days’’ and ‘‘7 day period’’ with
‘‘30 calendar days’’ and ‘‘30-day
period’’, respectively, in paragraph (c).
I D. By replacing ‘‘8 calendar days’’
with ‘‘31 calendar days’’ in paragraph
(e).
I E. By adding a new paragraph (g) to
read as follows:
I
I
I
§ 83.11 What happens to petitions that do
not satisfy all relevant requirements under
§§ 83.7 through 83.9?
*
*
*
*
*
(g) A petitioner whose petition has
been found not to satisfy the
requirements for a petition under either
paragraph (d) or (e) of this section may
submit to NIOSH a new petition for the
identical class of employees at any time
thereafter on the basis of new
information not provided to NIOSH in
the original petition. In such a case, the
petitioner is required to fully re-address
all the requirements of §§ 83.7–83.9 in
the petition.
I 4. Amend § 83.13 by revising
paragraph (d)(4) and adding paragraph
(e) to read as follows:
§ 83.13 How will NIOSH evaluate petitions,
other than petitions by claimants covered
under § 83.14?
*
*
*
*
*
(d)(4) A summary of the findings
concerning the adequacy of existing
records and information for
reconstructing doses for individual
members of the class under the methods
of 42 CFR part 82 specifying, for each
class defined in the report, whether
NIOSH finds that it is feasible to
estimate the radiation doses of members
PO 00000
Frm 00037
Fmt 4700
Sfmt 4700
37459
of the class with sufficient accuracy,
and a description of the evaluation
methods and information upon which
these findings are based; and
*
*
*
*
*
(e) The NIOSH report under
paragraph (d) of this section shall be
completed within 180 calendar days of
the receipt of the petition by NIOSH.
The procedure for computing this time
period is specified in § 83.5(c). In
addition, the computing of 180 calendar
days shall not include any days during
which the petitioner may be revising the
petition to remedy deficiencies
identified by NIOSH under § 83.11(a) or
(b), nor shall it include any days during
which the petitioner may request a
review of a proposed finding under
§ 83.11(c) or during the conduct of such
a review under § 83.11(d).
Dated: March 16, 2007.
Michael O. Leavitt,
Secretary, Department of Health and Human
Services.
Editorial Note: This document was
received in the Office of the Federal Register
on July 3, 2007.
[FR Doc. E7–13233 Filed 7–9–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 16
RIN 1018–AT29
Injurious Wildlife Species; Silver Carp
(Hypophthalmichthys molitrix) and
Largescale Silver Carp
(Hypophthalmichthys harmandi)
Fish and Wildlife Service,
Interior.
ACTION: Final rule.
AGENCY:
SUMMARY: The U.S. Fish and Wildlife
Service (Service or we) adds all forms of
live silver carp (Hypophthalmichthys
molitrix), gametes, viable eggs, and
hybrids; and all forms of live largescale
silver carp (Hypophthalmichthys
harmandi), gametes, viable eggs, and
hybrids to the list of injurious fish,
mollusks, and crustaceans under the
Lacey Act. The best available
information indicates that this action is
necessary to protect the interests of
human beings, and wildlife and wildlife
resources, from the purposeful or
accidental introduction, and subsequent
establishment, of silver carp and
largescale silver carp populations in
ecosystems of the United States. Live
silver carp and largescale silver carp,
gametes, viable eggs, and hybrids can be
E:\FR\FM\10JYR1.SGM
10JYR1
Agencies
[Federal Register Volume 72, Number 131 (Tuesday, July 10, 2007)]
[Rules and Regulations]
[Pages 37455-37459]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13233]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 83
RIN 0920-AA13
Procedures for Designating Classes of Employees as Members of the
Special Exposure Cohort Under the Energy Employees Occupational Illness
Compensation Program Act of 2000; Amendments
AGENCY: Department of Health and Human Services.
ACTION: Final Rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services is amending its
procedures for designating classes of employees to be added to the
Special Exposure Cohort under the Energy Employees Occupational Illness
Compensation Program Act of 2000 (EEOICPA). The final rule adds and
revises deadlines for evaluating petitions for cohort status, clarifies
when time periods commence and how they toll, and provides information
relevant to these deadlines on the content of petition evaluation
reports.
DATES: This Final Rule is effective July 10, 2007.
FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of
Compensation Analysis and Support, National Institute for Occupational
Safety and Health, 4676 Columbia Parkway, MS-C-46, Cincinnati, OH
45226, Telephone 513-533-6825 (this is not a toll free number).
Information requests can also be submitted by e-mail to OCAS@CDC.GOV.
SUPPLEMENTARY INFORMATION:
I. Purpose of Rulemaking
On October 28, 2004, the President signed the Ronald W. Reagan
National Defense Authorization Act for Fiscal Year 2005, Pub. L. 108-
375 (codified as amended in scattered sections of 42 U.S.C.). Division
C, Subtitle E, of this Act includes amendments to the Energy Employees
Occupational Illness Compensation Program Act of 2000 (``EEOICPA''), 42
U.S.C. 7384-7385. Several of these amendments, under Sec. 3166(b),
established new statutory requirements under 42 U.S.C. 7384q and
7384l(14)(C)(ii) that pertain to the Department of Health and Human
Services (``HHS'') procedures established under 42 CFR part 83:
``Procedures for Designating Classes of Employees as Members of the
Special Exposure Cohort under the Energy Employees Occupational Illness
Compensation Program Act of 2000.'' These new requirements included the
following: (1) Following the receipt of a petition for designation as
members of the Special Exposure Cohort (``the Cohort''), the National
Institute for Occupational Safety and Health (NIOSH) must submit ``a
recommendation'' on that petition, including all documentation, to the
Advisory Board on Radiation and Worker Health (``the Board'') within
180 days; (2) following the receipt by the Secretary of HHS (``the
Secretary'') of a recommendation by the Board that the Secretary
determine in the affirmative that a class meets the statutory criteria
for addition to the Cohort, the Secretary must submit to Congress a
determination as to whether or not the class meets these statutory
criteria within 30 days; (3) if the Secretary does not submit this
determination to Congress within 30 days, then on the 31st day it shall
be deemed that the Secretary has submitted a report to Congress that
designates, as an addition to the Cohort, the class recommended by the
Board for addition to the Cohort and that provides the criteria used to
support the designation; and (4) the period Congress shall have to
review a report submitted by the Secretary to designate a class as an
addition to the Cohort is reduced from 180 days to 30 days.
The purpose of the new requirements was to expedite the evaluation
and decision process for adding classes of employees to the Cohort.
On December 22, 2005, HHS issued an Interim Final Rule (IFR)
incorporating changes to ensure the new statutory requirements are met
and requesting public comment (70 FR 75950). The public comment period
for this rulemaking was initially to close on February 21, 2006. Upon a
request from the Board for additional time to comment, the comment
period was extended for 30 days and closed on March 23, 2006, after a
total of 90 days.
As discussed below, HHS has incorporated additional changes in this
Final Rule in response to comments from the Board and from the public.
These changes also bring the Final Rule into alignment with the
Congressional recommendations specified in the Conference Report
associated with the new statutory deadlines (H. Rep. 108-767).
II. Summary of Public Comments
The public comment period for the IFR extended from December 22,
2005 through March 23, 2006. HHS received comments from seven parties
in addition to the consensus comments of the Board. These include four
individuals, one U.S. Senator, one labor organization, and one advocacy
group. The comments are summarized and responded to below, together
with explanations of changes HHS has incorporated into this Final Rule.
A. 180-Day Deadline for NIOSH Recommendations
Several commenters, including the Board, recommended that HHS
reiterate in the final rule NIOSH's 180-day statutory deadline to
evaluate a petition and submit recommendations to the Board. One
commenter also wanted the rule to specify what actions HHS would take
if NIOSH failed to meet that deadline. In contrast, another commenter
recommended against including any of the statutory deadlines in the
rule because of concern that hastening the evaluation and
recommendation process could prevent
[[Page 37456]]
the full and fair consideration of petitions.
Commenters also raised concerns about various aspects of the IFR's
petition qualification and review process. Several commenters were
concerned that the rule did not include within the 180-day statutory
deadline NIOSH's process for identifying deficiencies in petitions.
They said the FY05 Defense Act Conference Report (H.Rep. 108-767)
indicated that Congress intended for the qualification process to be
included within the 180-day period, citing the following from the
Report:
During the 180 day period when NIOSH is preparing the petition
for review by the Advisory Board, NIOSH should identify all
deficiencies in the petition * * *
Most commenters, including the Board, also recommended that HHS
reinstate the 30-day period for petitioners to request a review of
NIOSH's proposed finding that a petition is deficient and does not
qualify for consideration. Finally, one commenter recommended that HHS
clarify in the rule that NIOSH will provide a recommendation for each
class of employees the petition covers.
In response to those comments, HHS has made several changes in the
final rule. First, HHS has added a reference to the 180-day deadline
for NIOSH to evaluate petitions and submit recommendations to the Board
(Sec. 83.13 (e)). The provisions in the IFR were designed to ensure
that NIOSH would meet the deadline. Referencing the 180-day deadline in
the final rule identifies the goal that the earlier changes are
intended to achieve.
Second, HHS has revised the rule so the process of determining
whether petitions are qualified is included in the 180-day period
(Sec. Sec. 83.5(k) and 83.11). HHS agrees with the commenters that
Congress intended to include that process in the 180-day period, and
the change brings the final rule into alignment with the Conference
Report.
As the commenters pointed out, the IFR did not include this process
in the 180-day period. In the preamble to the IFR, HHS said it was
necessary to exclude the process from the deadline to ensure that NIOSH
had adequate time to evaluate petitions and make recommendations within
the deadline. According to NIOSH, sometimes it can take months to
assist and consult with petitioners to help them remedy petition
deficiencies, which could significantly impact NIOSH's ability to do a
comprehensive evaluation before the deadline ended. Thus, in the IFR
HHS distinguished between ``submissions'' (i.e., petitions that were
not yet determined to meet the requirements of Sec. Sec. 83.7-83.9)
and ``petitions'' (i.e., petitions that have been determined to meet
the requirements) (Sec. 83.5(k)). The 180-day period started tolling
only when NIOSH received a ``petition'' (Sec. 83.5(k)). In the final
rule, HHS has deleted Sec. 83.5(k) and removed the distinction between
submissions and petitions in Sec. 83.11.
Third, HHS has reinstated the 30-day period for petitioners to
request a review of NIOSH's proposed finding that a petition is
deficient (Sec. 83.11). In the IFR, HHS had reduced the request period
to 7 days to increase the feasibility of NIOSH meeting the 180-day
deadline. To ensure that the additional time for requesting review does
not prevent NIOSH from meeting the deadline, HHS is adopting the
recommendation of one commenter that the clock on the 180 days start
when petitioners seek and are granted a review on whether their
petition satisfies all requirements. Accordingly, HHS has added new
paragraph (e) to Sec. 83.13 specifying that the 180-day period shall
not include any days during which (1) the petitioner is revising the
petition to remedy deficiencies NIOSH identified, (2) the petitioner
requests a review of NIOSH's proposed finding that the petition does
not meet all relevant requirements, or (3) the three-person HHS panel
(as authorized by Sec. 83.11(d)) is reviewing the petitioner's
request.
Finally, HHS has revised Sec. 83.13(d)(4) to clarify that NIOSH
evaluation report findings to the Board must specify whether it is
``feasible'' to estimate radiation doses with sufficient accuracy ``for
each class defined in the report.'' HHS is adding this specification
because NIOSH sometimes finds a Cohort petition covers more than one
class of employees even though it is submitted on behalf of a single
class. For example, in some cases, NIOSH will find differences in
radiation exposures and record availability for different employee
groups at the same facility. Consequently, NIOSH evaluation reports may
need to define more than one class of employees in the petition and
provide separate findings concerning each class. In light of NIOSH's
180-day deadline, HHS has also added language to paragraph (d)(4)
indicating that NIOSH's evaluation report must include a feasibility
finding about whether radiation doses for each class of employees can
be estimated with sufficient accuracy.
HHS did not adopt every recommendation commenters made. HHS has not
incorporated recommendations that NIOSH inform petitioners of all
deficiencies within the first 30 days (H. Rep. 108-767). HHS believes
the recommendation is not necessary. The changes in the final rule
specifying that the 180-day period begins when NIOSH receives a
petition gives the Agency more than adequate incentive to identify very
quickly whether the petition qualifies for consideration or has
deficiencies.
Also, HHS has not adopted the recommendation to add requirements to
the final rule specifying the actions HHS would take if NIOSH failed to
meet the 180-day deadline. HHS fully understands the EEOICPA statutory
amendments stressing the importance of evaluating petitions in a timely
manner. Although there may be complex circumstances of radiation
exposure or records availability or exceptional instances when it may
be challenging to complete a comprehensive evaluation covering all of
the classes of employees included in petition within 180 days, HHS will
make every effort to meet the deadline. The NIOSH Web page at
http:www.cdc.gov/NIOSH/ocas will continuously track the progress of
each active petition for the interested public.
B. Resubmission of Petitions Based on New Information
Two commenters indicated confusion concerning whether a petitioner
could submit a petition on behalf of a class of employees subsequent to
NIOSH finding that a prior petition covering the class did not meet the
petition requirements. The commenters believed that Sec. 83.11(f) only
permitted NIOSH, upon its own discretion, to consider a petition for a
class of employees for which a prior petition had already been found to
not meet petition requirements.
Nothing in the rule would prevent a petitioner from submitting a
subsequent petition based on new information. Such a petition would be
evaluated by NIOSH as a new petition. HHS has amended Sec. 83.11,
adding paragraph (g), to clarify that petitioners may submit an
additional petition for a class of employees, based on new information,
subsequent to NIOSH finding that a petition does not meet the petition
requirements specified in Sec. Sec. 83.7--83.9.
The existing paragraph (f) of Sec. 83.11 has a different purpose.
It is intended to allow NIOSH to reconsider a petition that it found to
not meet petition requirements, based on new information NIOSH might
obtain from any source, irrespective of any further action of the
petitioner.
[[Page 37457]]
C. Deadline for the Chair of the Board To Submit the Cohort Petition
Recommendations of the Board
One commenter recommended that HHS regulate the current policy of
the Board that requires the Chair to submit recommendations of the
Board on the outcome of Cohort petitions to the Secretary within 21
days of the Board's consensus formulation and approval of the
recommendations.
HHS has not incorporated this Board policy into the rule. Doing so
would violate the Administrative Procedure Act (``APA'') rulemaking
procedures specified in 5 U.S.C. 553 for the development of
regulations. The APA requires that the regulating agency both provide
the public with the opportunity for notice and comment and consider
submitted comments prior to promulgation of a final rule. The change
proposed by the commenter is not a reasonably foreseeable outcome of
the changes discussed in the IFR and making such a change would not
offer the public adequate notice of the change.
Furthermore, HHS does not consider it necessary or appropriate to
regulate this currently self-imposed policy of the Board. It is within
the Board's prerogative, with the guidance of the Designated Federal
Official, to set and manage its own deadlines.
D. Review of Proposed and Final Decisions of HHS on the Outcome of
Cohort Petitions
One commenter recommended HHS reinstate the opportunity for
petitioners to seek reviews of the proposed decisions on the outcome of
petitions, issued by the Director of NIOSH under Sec. 83.16(a), prior
to the issuance of final decisions by the Secretary of HHS.
As discussed in the preamble of the IFR (70 FR 75950, December 22,
2005), it is not possible for petitioners to seek and HHS to provide an
administrative review of the proposed decision, and for the Secretary
to issue a final decision, all within the 30-day Congressional report
deadline. For this reason, the administrative review opportunity of
petitioners was preserved but moved in the sequence of HHS actions to
follow, rather than precede, the Secretary's final decision.
Another commenter questioned whether the Secretary has discretion
in responding to an HHS administrative review of a final decision and
whether petitioners must seek such an administrative review as a
prerequisite to obtaining a judicial review of a final decision of the
Secretary issued under Sec. 83.17.
Under Sec. 83.18(c), the Secretary retains the discretion to
decide the outcome of a petition, after obtaining and considering the
information provided by the HHS administrative review. The authority to
decide the outcome of petitions was statutorily assigned to the
President (42 U.S.C. 7384q) and delegated to the Secretary by Executive
Order 13179.
The Secretary's decision to add or deny adding a class to the
Cohort is final unless he revises the decision pursuant to an
administrative review under Sec. 83.18 or Congress takes other action.
This administrative review is optional; neither EEOICPA nor this
regulation requires it as a prerequisite to judicial review.
E. Protection of the Personal Information of the Petitioner
One commenter recommended requiring that NIOSH disclose the
identities and contact information of petitioners. The commenter
reasoned that since the petitioner is acting on behalf of a class of
employees, the petitioner should not have the right to privacy.
The IFR did not propose imposing such a requirement on NIOSH or
petitioners in this Final Rule. Instead, HHS would first have to
provide public notice, the opportunity for public comment, and
consideration of comments submitted, as required for rulemaking under
the APA.
Moreover, the recommendation to require petitioners or NIOSH to
disclose the identity and contact information of the petitioners is
contrary to the customary protection afforded by the Federal government
to members of the public under the Privacy Act (5 U.S.C. 552a). In
particular, 5 U.S.C. 552a(b) bars agencies (subject to certain
exceptions not applicable here) from disclosing records such as those
at issue in the recommendation, where petitioner information is
``contained in a system of records'' that allows retrieval of such
records by unique person-specific identifiers, ``to any person, or to
another agency'' without the individual's written request or prior
written consent.
In addition, there does not appear to be a substantial
justification or benefit to requiring the disclosure of the identity
and contact information of the petitioner. A petitioner should not have
to choose between acting on his or her own behalf, as a member or a
survivor of a member of the class of employees represented in the
petition, and his or her right to privacy. It is true that the class of
employees includes other individuals who would also benefit from an
affirmative decision on the petition by the Secretary, but any other
member of the class of employees covered by the petition can obtain the
same rights as the petitioner by submitting a valid petition, meeting
the requirements specified under Sec. Sec. 83.7-83.9, on behalf of the
same class of employees.
F. Authority and Deadline for the Secretary To Decide on Petitions
Two commenters appeared to have misunderstood the statutory
requirement that the President render a decision regarding the addition
of a class of employees to the Cohort within 30 days of the Board
having recommended its addition (see 42 U.S.C. 7384q(c)(2)(A)-(B)) to
newly authorize the President's involvement in these decisions. One
commenter recommended that the President not be given the role of
making such decisions, and the second commenter recommended that the
President not be provided 30 days to make such decisions, as the
commenter believed this would prolong the decision-making process.
Since EEOICPA was originally enacted in 2000, the President has
been solely authorized in the statute to decide whether or not to
designate classes of employees for addition to the Cohort. The
President delegated this authority to the Secretary, who has
implemented this authority ever since. The only change made by the
statutory requirement discussed above is to impose a 30-day deadline on
the President to make such decisions in certain cases. As discussed in
the IFR, this 30-day deadline applies to the Secretary's decisions,
since the President delegated this decision-making authority to the
Secretary. The deadline does not prolong the decision-making process
since, prior to this statutory requirement, the Secretary was not under
any deadline to make such decisions.
G. Non-Regulatory Comments
HHS received several comments that do not pertain to the IFR. These
included a comment to add a class of employees from the Hanford
facility to the Cohort, a personal perspective on the history of the
management of the U.S. nuclear weapons program, concerns about the
involvement of the Office of Management and Budget (``OMB'') in the
program, and a speculation that adding classes of employees to the
Cohort would be cost-saving compared to the conduct of dose
reconstructions.
[[Page 37458]]
The Board recommended NIOSH provide petitioners with guidance in
the form of a timeline for the petition process, to ensure petitioners
understand the expected duration of the entire process and its
elements, from the submission of a petition to the point at which final
decisions on a petition become effective. NIOSH will provide each
petitioner with such guidance, together with other introductory
materials provided to petitioners upon the receipt by NIOSH of a
petition.
One commenter suggested all cancers be added to the list of 22
``specified cancers'' covered for members of the Cohort. The list of
specified cancers covered for members of the Cohort is established
statutorily under EEOICPA and not governed by this rulemaking. EEOICPA
states:
The term ``specified cancer'' means any of the following:
(A) A specified disease, as that term is defined in section 4(b)(2)
of the Radiation Exposure Compensation Act (42 U.S.C. 2210 note).
(B) Bone cancer.
(C) Renal cancers.
(D) Leukemia (other than chronic lymphocytic leukemia), if initial
occupational exposure occurred before 21 years of age and onset
occurred more than two years after initial occupational exposure. 42
U.S.C. 7384l(17)
III. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
agency must determine whether a regulatory action is ``significant''
and therefore subject to review by OMB and the requirements of the
Executive Order. Under section 3(f), the order defines a ``significant
regulatory action'' as an action that is likely to result in a rule (1)
having an annual effect on the economy of $100 million or more, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, or tribal governments or communities (also
referred to as ``economically significant''); (2) creating serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlements, grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the executive order.
This rule is being treated as a ``significant regulatory action''
within the meaning of the executive order because it meets the
criterion of Section 3(f)(4) in that it raises novel or legal policy
issues arising out of the legal mandate established by EEOICPA. It
amends current procedures by which the Secretary considers petitions to
add classes of employees to the Cohort to comport with new statutory
deadlines (see 42 U.S.C. 7384q(c)(2)(A) and 42 U.S.C.
7384l(14)(C)(ii)). The revisions, however, neither affect the financial
cost to the federal government of responding to these petitions nor the
scientific and policy bases for making decisions on such petitions.
The rule carefully explains the manner in which the procedures are
consistent with the mandates of 42 U.S.C. 7384q and 7384l(14)(C)(ii)
and implements the detailed requirements of these sections. The rule
does not interfere with State, local, and tribal governments in the
exercise of their governmental functions.
The rule is not considered economically significant, as defined in
Sec. 3(f)(1) of Executive Order 12866. As discussed above, it does not
affect the financial cost to the federal government of responding to
these petitions nor does it affect the scientific and policy bases for
making decisions on such petitions. Furthermore, it has a subordinate
role in the adjudication of claims under EEOICPA, serving as one
element of an adjudication process administered by the Department of
Labor (``DOL'') under 20 CFR parts 1 and 30. DOL has determined that
its rule fulfills the requirements of Executive Order 12866 and
provides estimates of the aggregate cost of benefits and administrative
expenses of implementing EEOICPA under its rule (see 71 FR 78520,
December 29, 2006). OMB has reviewed this rule for consistency with the
President's priorities and the principles set forth in Executive Order
12866.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (``RFA''), 5 U.S.C. 601 et. seq.,
requires each agency to consider the potential impact of its
regulations on small entities, including small businesses, small
governmental units, and small not-for-profit organizations. HHS
certifies that this rule will not have a significant economic impact on
a substantial number of small entities within the meaning of the RFA.
The rule affects only HHS, DOL, the Department of Energy, and certain
individuals covered by EEOICPA. Therefore, a regulatory flexibility
analysis as provided for under RFA is not required.
C. What Are the Paperwork and Other Information Collection Requirements
(Subject to the Paperwork Reduction Act) Imposed Under This Rule?
The Paperwork Reduction Act (``PRA'') 44 U.S.C. 3501 et seq.,
requires an agency to invite public comment on and to obtain OMB
approval of any regulation that requires ten or more people to report
information to the agency or to keep certain records. The Special
Exposure Cohort rule, 42 CFR part 83, which requires the collection of
information from petitioners, is covered by the PRA and has received
OMB clearance (OMB control 0920-0639). However, this
rulemaking, which makes limited changes to 42 CFR part 83, does not
contain any information collection requirements. Thus, HHS has
determined that the PRA does not apply to this rulemaking.
D. Small Business Regulatory Enforcement Fairness Act
As required by Congress under the Small Business Regulatory
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), HHS will
report to Congress promulgation of this rule prior to its taking
effect. The report will state that HHS has concluded that this rule is
not a ``major rule'' because it is not likely to result in an annual
effect on the economy of $100 million or more. However, this rule has a
subordinate role in the adjudication of claims under EEOICPA, serving
as one element of an adjudication process administered by DOL under 20
CFR parts 1 and 30. DOL has determined that its rule is a ``major
rule'' because it will likely result in an annual effect on the economy
of $100 million or more.
E. Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531
et seq.) directs agencies to assess the effects of federal regulatory
actions on State, local, and tribal governments and the private sector
``other than to the extent that such regulations incorporate
requirements specifically set forth in law.'' For purposes of the
Unfunded Mandates Reform Act, this rule does not include any federal
mandate that may result in increased annual expenditures in excess of
$100 million by state, local or tribal governments in the aggregate, or
by the private sector.
F. Executive Order 12988 (Civil Justice)
This rule has been drafted and reviewed in accordance with
Executive
[[Page 37459]]
Order 12988 on Civil Justice Reform and will not unduly burden the
federal court system. HHS adverse decisions may be reviewed in United
States District Courts pursuant to the APA. HHS has attempted to
minimize that burden by providing petitioners an opportunity to seek
administrative review of adverse decisions. HHS has provided a clear
legal standard it will apply in considering petitions. This rule has
been reviewed carefully to eliminate drafting errors and ambiguities.
G. Executive Order 13132 (Federalism)
HHS has reviewed this rule in accordance with Executive Order 13132
regarding federalism, and has determined that it does not have
``federalism implications.'' The rule does 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.''
H. Executive Order 13045 (Protection of Children From Environmental,
Health Risks and Safety Risks)
In accordance with Executive Order 13045, HHS has evaluated the
environmental health and safety effects of this rule on children. HHS
has determined that the rule would have no effect on children.
I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)
In accordance with Executive Order 13211, HHS has evaluated the
effects of this rule on energy supply, distribution or use, and has
determined that the rule will not have a significant adverse effect on
them.
J. Effective Date
The Secretary has determined, pursuant to 5 U.S.C. 553(d)(3), that
there is good cause for this rule to be effective immediately to
eliminate legal inconsistencies between new statutory requirements
under 42 U.S.C. 7384l and 7384q and regulatory requirements under 42
CFR part 83 and to make the implementation of the new statutory
requirements feasible.
List of Subjects in 42 CFR Part 83
Government employees, Occupational safety and health, Nuclear
materials, Radiation protection, Radioactive materials, Workers'
compensation.
Text of the Rule
0
For the reasons discussed in the preamble, the interim rule amending 42
CFR part 83, published on December 22, 2005 (70 FR 75950), is confirmed
as final with the folling changes:
PART 83--[AMENDED]
0
1. The authority citation for part 83 continues to read as follows:
Authority: 42 U.S.C. 7384q; E.O. 13179, 65 FR 77487, 3 CFR, 2000
Comp., p. 321.
Subpart B--Definitions
Sec. 83.5 [Amended]
0
2. Amend Sec. 83.5 by removing paragraph (k) and redesignating
paragraphs (l) through (p) as paragraphs (k) through (o), respectively.
Subpart C--Procedures for Adding Classes of Employees to the Cohort
0
3. Amend Sec. 83.11 as follows:
0
A. By revising the section heading.
0
B. By replacing the term ``submission'' with the term ``petition'' in
paragraphs (a) through (d) and (f).
0
C. By replacing the phrases ``7 calendar days'' and ``7 day period''
with ``30 calendar days'' and ``30-day period'', respectively, in
paragraph (c).
0
D. By replacing ``8 calendar days'' with ``31 calendar days'' in
paragraph (e).
0
E. By adding a new paragraph (g) to read as follows:
Sec. 83.11 What happens to petitions that do not satisfy all relevant
requirements under Sec. Sec. 83.7 through 83.9?
* * * * *
(g) A petitioner whose petition has been found not to satisfy the
requirements for a petition under either paragraph (d) or (e) of this
section may submit to NIOSH a new petition for the identical class of
employees at any time thereafter on the basis of new information not
provided to NIOSH in the original petition. In such a case, the
petitioner is required to fully re-address all the requirements of
Sec. Sec. 83.7-83.9 in the petition.
0
4. Amend Sec. 83.13 by revising paragraph (d)(4) and adding paragraph
(e) to read as follows:
Sec. 83.13 How will NIOSH evaluate petitions, other than petitions by
claimants covered under Sec. 83.14?
* * * * *
(d)(4) A summary of the findings concerning the adequacy of
existing records and information for reconstructing doses for
individual members of the class under the methods of 42 CFR part 82
specifying, for each class defined in the report, whether NIOSH finds
that it is feasible to estimate the radiation doses of members of the
class with sufficient accuracy, and a description of the evaluation
methods and information upon which these findings are based; and
* * * * *
(e) The NIOSH report under paragraph (d) of this section shall be
completed within 180 calendar days of the receipt of the petition by
NIOSH. The procedure for computing this time period is specified in
Sec. 83.5(c). In addition, the computing of 180 calendar days shall
not include any days during which the petitioner may be revising the
petition to remedy deficiencies identified by NIOSH under Sec.
83.11(a) or (b), nor shall it include any days during which the
petitioner may request a review of a proposed finding under Sec.
83.11(c) or during the conduct of such a review under Sec. 83.11(d).
Dated: March 16, 2007.
Michael O. Leavitt,
Secretary, Department of Health and Human Services.
Editorial Note: This document was received in the Office of the
Federal Register on July 3, 2007.
[FR Doc. E7-13233 Filed 7-9-07; 8:45 am]
BILLING CODE 4163-18-P