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; Interim Final Rule With Request for Comments, 75949-75954 [05-24358]
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Federal Register / Vol. 70, No. 245 / Thursday, December 22, 2005 / Rules and Regulations
benefits must complete Part A of the
Certification of Traumatic Injury
Protection Form and sign the form.
(ii) If a member is unable to do so,
anyone acting on the member’s behalf
may request a Certification of Traumatic
Injury Protection Form from the
uniformed service. However, the
Certification of Traumatic Injury
Protection Form must be signed by the
member, the member’s guardian, or the
member’s attorney-in-fact.
(iii) If a member suffered a scheduled
loss as a direct result of the traumatic
injury, survived seven full days from the
date of the traumatic event, and then
died before the maximum benefit for
which the service member qualifies is
paid the beneficiary or beneficiaries of
the member’s Servicemembers’ Group
Life Insurance policy should complete a
Certification of Traumatic Injury
Protection Form.
(2) If a member seeks traumatic injury
protection benefits for a scheduled loss
occurring after submission of a
completed Certification of Traumatic
Injury Protection Form for a different
scheduled loss, the member must
submit a completed Certification of
Traumatic Injury Protection Form for
the new scheduled loss and for each
scheduled loss that occurs thereafter.
For example, if a member seeks
traumatic injury protection benefits for
a scheduled loss due to coma from
traumatic injury and/or the inability to
carry out activities of daily living due to
traumatic brain injury
(§ 9.20(e)(7)(xxxvii)), or the inability to
carry out activities of daily living due to
loss directly resulting from a traumatic
injury other than an injury to the brain
(§ 9.20(e)(7)(xliv)), a completed
Certification of Traumatic Injury
Protection Form must be submitted for
each increment of time for which TSGLI
is payable. Also, for example, if a
service member suffers a scheduled loss
due to a coma, a completed Certification
of Traumatic Injury Protection Form
should be filed after the 15th
consecutive day that the member is in
the coma, for which $25,000 is payable.
If the member remains in a coma for
another 15 days, another completed
Certification of Traumatic Injury
Protection Form should be submitted
and another $25,000 will be paid.
(h) How does a member or beneficiary
appeal an adverse eligibility
determination? (1) Notice of a decision
regarding a member’s eligibility for
traumatic injury protection benefits will
include an explanation of the procedure
for obtaining review of the decision. An
appeal of an eligibility determination,
such as whether the loss occurred
within 365 days of the traumatic injury,
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whether the injury was self-inflicted or
whether a loss of hearing was total and
permanent, must be in writing. An
appeal must be submitted by a member
or a member’s legal representative or by
the beneficiary or the beneficiary’s legal
representative, within one year of the
date of a denial of eligibility, to the
office of the uniformed service
identified in the decision regarding the
member’s eligibility for the benefit.
(2) An appeal regarding whether a
member was insured under
Servicemembers’ Group Life Insurance
when the traumatic injury was
sustained must be in writing. An appeal
must be submitted by a member or a
member’s legal representative or by the
beneficiary or the beneficiary’s legal
representative within one year of the
date of a denial of eligibility to the
Office of Servicemembers’ Group Life
Insurance.
(3) Nothing in this section precludes
a member from pursuing legal remedies
under 38 U.S.C. 1975 and 38 CFR 9.13.
(i) Who will be paid the traumatic
injury protection benefit? The injured
member who suffered a scheduled loss
will be paid the traumatic injury
protection benefit in accordance with
title 38 U.S.C. 1980A except under the
following circumstances:
(1) If a member is legally
incapacitated, the member’s guardian or
attorney-in-fact will be paid the benefit
on behalf of the member.
(2) If a member dies before payment
is made, the beneficiary or beneficiaries
who will be paid the benefit will be
determined in accordance with 38
U.S.C. 1970(a).
(Authority: 38 U.S.C. 501(a) and 1980A)
[FR Doc. 05–24390 Filed 12–20–05; 10:53
am]
BILLING CODE 8320–01–P
75949
its procedures to consider designating
classes of employees to be added to the
Special Exposure Cohort under the
Energy Employees Occupational Illness
Compensation Program Act of 2000
(‘‘EEOICPA’’), 42 U.S.C. 7384–7385.
HHS must change these procedures to
implement amendments to EEOICPA
enacted on October 28, 2004, as part of
the Ronald W. Reagan National Defense
Authorization Act for Fiscal Year 2005,
Public Law 108–375 (codified as
amended in scattered sections of 42
U.S.C.).
Effective Date: This interim final
rule is effective December 22, 2005.
Comments: The Department invites
written comments on the interim final
rule from interested parties. Comments
on the rule must be received by
February 21, 2006.
DATES:
Address written comments
on the interim final rule to the National
Institute for Occupational Safety and
Health (‘‘NIOSH’’) Docket Officer
electronically by e-mail to
NIOCINDOCKET@cdc.gov. See
SUPPLEMENTARY INFORMATION for file
formats and other information about
electronic filing. Alternatively, submit
printed comments to NIOSH Docket
Office, Robert A. Taft Laboratories, MS–
C34, 4676 Columbia Parkway,
Cincinnati, OH 45226.
ADDRESSES:
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 513–533–6800 (this is
not a toll free number). Information
requests can also be submitted by e-mail
to OCAS@cdc.gov.
SUPPLEMENTARY INFORMATION:
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; Interim Final Rule With
Request for Comments
Department of Health and
Human Services.
ACTION: Interim final rule with request
for comments.
AGENCY:
SUMMARY: The Department of Health and
Human Services (‘‘HHS’’) is amending
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I. Comments Invited
Interested persons or organizations
are invited to participate in this
rulemaking by submitting written views,
arguments, recommendations, and data.
Comments are invited on any topic
related to the changes in the Special
Exposure Cohort (‘‘the Cohort’’) rule (42
CFR part 83) effectuated by this
rulemaking. Comments concerning any
other provisions of the Cohort rule,
unchanged and unaffected by this
rulemaking, will not be considered.
Comments should identify the
author(s), return address, and phone
number, in case clarification is needed.
Comments can be submitted by e-mail
to: NIOCINDOCKET@cdc.gov.
Comments submitted by e-mail may be
provided as e-mail text or as a Word or
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Word Perfect file attachment. Printed
comments can also be submitted to the
address above. All communications
received on or before the closing date
for comments will be fully considered
by the Secretary. An electronic docket
containing all comments submitted will
be available over the Internet on the
Web page of the National Institute for
Occupational Safety and Health
(‘‘NIOSH’’), Office of Compensation
Analysis and Support at https://
www.cdc.gov/niosh/ocas, and comments
will be available in writing by request.
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II. Purpose of Rulemaking
On October 28, 2004, the President
signed the Ronald W. Reagan National
Defense Authorization Act for Fiscal
Year 2005, Public Law 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 (‘‘EEOICPA’’) 42 U.S.C.
7384–7385. Several of these
amendments, under section 3166 (b),
establish new statutory requirements
under 42 U.S.C. 7384q and
7384l(14)(C)(ii), relevant 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 include the
following: (1) Following the receipt by
NIOSH of a petition for designation as
members of the Cohort, 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 it shall be
deemed that the Secretary has submitted
a report to Congress on the 31st day 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 for
Congress to review a report submitted
by the Secretary to designate a class as
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an addition to the Cohort is reduced
from 180 days to 30 days.
To implement these new
requirements, HHS must amend 42 CFR
part 83. As discussed below, some of the
changes to the HHS rule are necessary
legally for compliance with the new
requirements and other changes are
necessary to make implementation of
the requirements feasible.
III. Summary of the Rule Changes
HHS has made changes to four
sections of the Cohort rule to implement
the new statutory requirements
summarized above. These changes are
described below in relation to the
relevant statutory requirement.
A. 180-Day Deadline for NIOSH
Recommendations
HHS has amended §§ 83.5 and 83.11
of the rule to enable NIOSH to meet the
statutory requirement that NIOSH
submit to the Board ‘‘a
recommendation’’ on a petition within
180 days of its receipt (see 42 U.S.C.
7384q(c)(1)). The change to § 83.5
provides a definition of a petition,
which was previously undefined in the
rule, to specify that only submissions by
qualified petitioners that meet the
informational and procedural
requirements of a petition under the
rule will be considered to be ‘‘petitions’’
and hence will be covered by the 180day deadline. This provision is
necessary to clarify that the submission
of a petition by an unqualified
petitioner or the submission of an
incomplete petition does not initiate the
180-day requirement. NIOSH experience
with petitions demonstrates that it may
take months to assist and consult with
petitioners to help make incompletely
submitted petitions as complete and
accurate as possible. Starting the 180day requirement after such preparatory
work of the petitioners will help
support the completion of the NIOSH
evaluation of the petition within 180day deadline. NIOSH will provide
written notification to the submitter
indicating the official date the
submission qualified as a petition, thus
starting the 180-day deadline for
providing a recommendation to the
Board.
The changes to § 83.11 support the
distinction between an incomplete or
non-qualifying submission and a
petition, which is subject to the 180-day
deadline. They include the substitution
of the term ‘‘submission’’ for ‘‘petition’’
where appropriate.
HHS has also amended paragraph (c)
of § 83.11 to reduce, from 30 to 7
calendar days, the time during which a
petitioner can request a review of a
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proposed finding by NIOSH that the
petition fails to meet the specified
requirements. Seven days is sufficient
time for the petitioner to make such a
request and the 21 days potentially
saved by such a change are necessary to
support the completion of the NIOSH
evaluation of the petition within 180
days, should the review determine that
the petition satisfies the requirements of
a petition. Consistent with this change,
HHS has also amended paragraph (e) of
§ 83.11 to reduce, from 31 to 8 calendar
days, the time at which a proposed
finding by NIOSH under paragraph (b)
becomes final if no review is conducted.
B. 30-Day Deadline for Determinations
by HHS
HHS has amended §§ 83.16 and 83.17
and added a new § 83.18 of the rule to
enable HHS to meet the statutory
requirement that the Secretary submit to
Congress determinations as to whether
or not a class meets the statutory criteria
for addition to the Cohort within 30
days of the Secretary receiving a
recommendation by the Board to make
an affirmative determination in this
regard (see 42 U.S.C. 7384q(c)(2)(A)–
(B)). The changes to § 83.16 remove the
opportunity for petitioners to seek an
administrative review of proposed
decisions by the Director of NIOSH.
This change is being made because it
would not be possible for the Director
of NIOSH to issue a proposed decision,
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.
HHS has added provisions under a
new § 83.18 (the existing § 83.18 is
redesignated as § 83.19) to provide
petitioners with the opportunity to seek
administrative reviews of final decisions
by the Secretary, since petitioners will
no longer have the opportunity to seek
administrative reviews of proposed
decisions. This new administrative
review opportunity is essentially
identical to that provided previously
under § 83.16 for proposed decisions.
Under § 83.16(c) and § 83.17(b), HHS
has provided for the Secretary to submit
to Congress within 30 days the
determinations required under the
statutory 30-day deadline.
C. Computation of Time Periods
HHS has added a new paragraph (c)
‘‘Computation of Time Periods’’ under
§ 83.5 to specify how HHS and NIOSH
will count the time periods for the
various deadlines included in the rule.
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IV. Regulatory Procedures
HHS follows the Administrative
Procedure Act (‘‘PA’’) rulemaking
procedures specified in 5 U.S.C. 553 for
the development of its regulations. In
most circumstances, the APA requires a
public notice and comment period and
consideration of the submitted
comments prior to promulgation of a
final rule having the effect of law.
However, the APA provides for
exceptions to its notice-and-comment
procedures when an agency finds that
there is good cause for dispensing with
such procedures on the basis that they
are impracticable, unnecessary, or
contrary to the public interest. In the
case of this interim final rule, HHS has
determined that under 5 U.S.C.
553(b)(B), good cause exists for waiving
the notice and comment procedures. For
these same reasons, HHS has also
determined that good cause exists under
5 U.S.C. 553(d)(3) for these interim rules
to become effective immediately.
A number of courts have considered
the circumstances under which an
agency can conclude that good cause
exists for issuing regulations without
prior notice and comment. In American
Transfer & Storage Co., et al. v.
Interstate Commerce Commission, 719
F.2d 1283, 1295 (5th Cir. 1983), the
Fifth Circuit described the
impracticability test as requiring
‘‘analysis in practical terms of the
particular statutory-agency setting and
the reasons why agency action could not
await notice and comment.’’ Similarly,
the Seventh Circuit noted that the
‘‘legislative history of the
impracticability standard reveals that
Congress intended this exemption to
operate when the regular course of
rulemaking procedure would interfere
with the agency’s ability to perform its
functions with the time constraints
imposed by Congress.’’ United States
Steel Corporation v. United States
Environmental Protection Agency, 605
F.2d 283, 287 (7th Cir. 1979).
Precisely such an ‘‘analysis in
practical terms’’ demonstrates that in
this case, HHS cannot await the process
of notice and comment to implement
the changes to 42 CFR part 83 set forth
here on an interim final basis. As
discussed above, the amendments to
EEOICPA addressed by this rulemaking
directly conflict, legally and practically,
with the existing provisions of the
existing provisions of the HHS rule. The
potential consequences of these
conflicts are that HHS would have to
violate the legal requirements of its rule
to uphold the statutory requirements of
the EEOICPA amendments.
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Specifically, under the new 30-day
statutory deadline for producing HHS
determinations on petitions that the
Board recommends receive affirmative
determinations (42 U.S.C.
7384q(c)(2)(A)), HHS would not be able
to produce a proposed decision, provide
petitioners with the opportunity to
contest the proposed decision, and
provide an administrative review of
such a challenge prior to issuing a final
decision with respect to the
determination, as previously provided
for under § 83.16(a)–(c) of the rule.
Similarly, the reduction in the
statutorily-set congressional review
period for designations by the Secretary
of additions to the Cohort, from 180
days to 30 days (42 U.S.C.
7384l(14)(C)(ii)), conflicts with
§ 83.17(b) of the rule, which mandates a
period of 180 days before a designation
by the Secretary would become
effective.
If HHS were to issue a notice of
proposed rulemaking proposing changes
to the Cohort procedures, HHS would
have to violate either the new statutory
requirements or its Cohort regulations
for each Cohort petition that is
considered, until a final regulation
could be issued. Hence, HHS believes
good cause exists to waive the notice
and comment procedures under the
APA for the promulgation of this
interim final rule.
Although HHS is adopting this rule
on an interim final basis, it requests
public comment on this rule. After full
consideration of public comments, HHS
will publish a final rule with any
necessary changes. HHS expects to issue
a final rule within six months of the
publication of this interim final rule.
V. 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 the Office of
Management and Budget (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
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75951
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 amendment
also includes the provision of the
opportunity for certain affected parties
to obtain administrative reviews of final
agency actions, versus proposed agency
actions. The revisions do not, however,
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 the Executive Order 12866.
As discussed above, it does not 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. 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 (‘‘OL’’) 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 70 FR 33590, June 8, 2005). OMB
has reviewed this rule for consistency
with the President’s priorities and the
principles set forth in Executive Order
12866.
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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. This
rule, 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 rule.
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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
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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.
List of Subjects in 42 CFR Part 83
F. Executive Order 12988 (Civil Justice)
Text of the Rule
This rule has been drafted and
reviewed in accordance with Executive
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.
Government employees, Occupational
safety and health, Nuclear materials,
Radiation protection, Radioactive
materials, Workers’ compensation.
For the reasons discussed in the
preamble, HHS amends 42 CFR part 83
to read as follows:
I
PART 83—[AMENDED]
1–2. 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
3. Amend § 83.5 by redesignating
paragraphs (j) through (n) as (l) through
(p), respectively and by redesignating
paragraphs (c) through (i) as (d) through
(j), respectively, and by adding new
paragraphs (c) and (k) to read as follows:
I
§ 83.5 Definition of terms used in the
procedures in this part.
*
*
*
*
*
(c) Computation of Time Periods: In
this Rule, all prescribed or allowed time
periods will be counted as calendar
days from the business day of receipt by
the submitter(s), the petitioner(s),
NIOSH, or HHS. Receipt by NIOSH, the
submitter(s) or petitioner(s) will be
either the business day of actual receipt
or three (3) business days after initial
proof of mailing, whichever time period
is shorter. Business days are defined as
Monday through Friday, 8 a.m. to 4:30
p.m. est and ‘‘legal holiday’’ will be
used as defined by the FED. R. CIV. P.
6(a).
*
*
*
*
*
(k) Petition means a submission under
§ 83.8 of this part that meets all the
requirements of §§ 83.7–83.9 of this part
and has incorporated any revisions
made by the petitioner under §§ 83.7–
83.9 or § 83.11 of this part.
*
*
*
*
*
Subpart C—Procedures for Adding
Classes of Employees to the Cohort
4. Revise § 83.11 to read as follows:
J. Effective Date
I
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.
§ 83.11 What happens to petition
submissions that do not satisfy all relevant
requirements under §§ 83.7 through 83.9?
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(a) NIOSH will notify the petitioner(s)
of any requirement that is not met by
the submission, assist the petitioner(s)
with guidance in developing relevant
information, and provide 30 calendar
days for the petitioner(s) to revise the
submission accordingly.
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Federal Register / Vol. 70, No. 245 / Thursday, December 22, 2005 / Rules and Regulations
(b) After 30 calendar days from the
date of notification under paragraph (a)
of this section, NIOSH will notify any
petitioner(s) whose submission remains
unsatisfactory of the proposed finding of
NIOSH that the submission fails to meet
the specified requirements and the basis
for this finding.
(c) A petitioner may request in writing
a review of a proposed finding within 7
calendar days of notification under
paragraph (b) of this section. Petitioners
must specify why the proposed finding
should be reversed, based on the
petition requirements and on the
information that the petitioners had
already submitted. The request may not
include any new information or
documentation that was not included in
the completed submission. If the
petitioner obtains new information
within this 7 day period, the petitioner
should provide it to NIOSH. NIOSH will
consider this new information as a
revision of the submission under
paragraph (a) of this section.
(d) Three HHS personnel, appointed
by the Director of NIOSH, who were not
involved in developing the proposed
finding will complete reviews within 30
work days of the request for such a
review. The Director of NIOSH will
consider the results of the review and
then make a final decision as to whether
the submission satisfies the
requirements for a petition.
(e) Proposed findings established by
NIOSH under paragraph (b) of this
section will become final decisions in 8
calendar days if not reviewed under
paragraph (d) of this section.
(f) Based on new information, NIOSH
may, at its discretion, reconsider a
decision that a submission does not
satisfy the requirements for a petition.
I 5. Revise § 83.16 to read as follows:
cprice-sewell on PROD1PC66 with RULES
§ 83.16 How will the Secretary decide the
outcome(s) of a petition?
(a) The Director of NIOSH will
propose a decision to add or deny
adding any class or classes of employees
to the Cohort, including an iteration of
the relevant criteria, as specified under
§ 83.13(c), and a summary of the
information and findings on which the
proposed decision is based. This
proposed decision will take into
consideration the evaluations of NIOSH
and the report and recommendations of
the Board, and may also take into
consideration information presented or
submitted to the Board and the
deliberations of the Board. In the case of
a petition that NIOSH has determined
encompasses more than one class of
employees, the Director of NIOSH will
issue a separate proposed decision for
each separate class of employees.
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15:00 Dec 21, 2005
Jkt 208001
(b) The Secretary will make the final
decision to add or deny adding a class
to the Cohort, including the definition
of the class, after considering
information and recommendations
provided to the Secretary by the
Director of NIOSH and the Board. HHS
will transmit a report of the decision to
the petitioner(s), including an iteration
of the relevant criteria, as specified
under § 83.13(c), and a summary of the
information and findings on which the
decision is based. HHS will also publish
a notice summarizing the decision in
the Federal Register.
(c) If, under § 83.15(e), the Board
recommends that the Secretary
designate a class covered by the petition
as an addition to the Cohort, and if,
under paragraph (b) of § 83.16, the
Secretary decides to deny adding the
class, as defined by the Board, to the
Cohort, then the Secretary will submit
to Congress a determination that the
statutory criteria specified under 42
U.S.C. 7384q(b)(1) and (2) have not been
met for adding the class to the Cohort.
The Secretary will submit this
determination to Congress within 30
calendar days following receipt by the
Secretary of the recommendation of the
Board.
I 6. Amend § 83.17 by redesignating
paragraphs (b), (c), and (d), as (c), (d),
and (e), respectively, and by adding new
paragraph (b), and revising newly
redesignated paragraphs (c) and (e) to
read as follows:
§ 83.17 How will the Secretary report a
final decision to add a class of employees
to the Cohort and any action of Congress
concerning the effect of the final decision?
*
*
*
*
*
(b) If, under § 83.15(e), the Board
recommends that the Secretary
designate a class covered by the petition
as an addition to the Cohort, and if,
under paragraph (b) of § 83.16, the
Secretary decides to add a class to the
Cohort that is inclusive of the class as
defined by the Board, then the Secretary
will transmit to Congress the report
specified in paragraph (a) of this section
within 30 calendar days following
receipt by the Secretary of the
recommendation of the Board.
(c) A designation of the Secretary will
take effect 30 calendar days after the
date on which the report of the
Secretary under paragraph (a) of this
section is submitted to Congress, or is
deemed to have been submitted to
Congress,5 unless Congress takes an
5 Under 42 U.S.C. 7384q(c)(2)(C), if the Secretary
does not submit within 30 days the determination
required under paragraph (a) of § 83.17 of this part,
then on the following day, ‘‘it shall be deemed’’ that
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Fmt 4700
Sfmt 4700
75953
action that reverses or expedites the
designation.
*
*
*
*
*
(e) The report specified under
paragraph (d) of this section will be
published on the Internet at https://
www.cdc.gov/niosh/ocas and in the
Federal Register.
§ 83.18
[Redesignated as § 83.19]
7. Redesignate § 83.18 as § 83.19.
I 8. Add a new § 83.18 to read as
follows:
I
§ 83.18 How can petitioners obtain an
administrative review of a final decision by
the Secretary?
(a) HHS will allow petitioners to
contest only a final decision to deny
adding a class to the Cohort or a health
endangerment determination under
§ 83.13(c)(3)(ii). Such challenges must
be submitted in writing within 30
calendar days and must include
evidence that the final decision relies on
a record of either substantial factual
errors or substantial errors in the
implementation of the procedures of
this part. Challenges may not introduce
new information or documentation
concerning the petition or the NIOSH or
Board evaluation(s) that was not
submitted or presented by the
petitioner(s) or others to NIOSH or to
the Board prior to the Board’s issuing its
recommendations under § 83.15.
(b) A panel of three HHS personnel,
independent of NIOSH and appointed
by the Secretary, will conduct an
administrative review based on a
challenge submitted under paragraph (a)
of this section and provide
recommendations of the panel to the
Secretary concerning the merits of the
challenge and the resolution of issues
contested by the challenge. Reviews by
the panel will consider, in addition to
the views and information submitted by
the petitioner(s) in the challenge, the
NIOSH evaluation report(s), the report
containing the recommendations of the
Board issued under § 83.15, and
recommendations of the Director of
NIOSH to the Secretary. The reviews
may also consider information
presented or submitted to the Board and
the deliberations of the Board prior to
the issuance of the recommendations of
the Board under § 83.15. The panel shall
consider whether HHS substantially
complied with the procedures of this
part, the factual accuracy of the
information supporting the final
decision, and the principal findings and
recommendations of NIOSH and those
of the Board issued under § 83.15.
the Secretary submitted the report specified under
paragraph (b) of § 83.17 of this part.
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Federal Register / Vol. 70, No. 245 / Thursday, December 22, 2005 / Rules and Regulations
(c) The Secretary will decide whether
or not to revise a final decision
contested by the petitioner(s) under this
section after considering information
and recommendations provided to the
Secretary by the Director of NIOSH, the
Board, and from the HHS administrative
review conducted under paragraph (b)
of this section. HHS will transmit a
report of the decision to the
petitioner(s).
(d) If the Secretary decides under
paragraph (c) of this section to change
a designation under § 83.17(a) of this
part or a determination under § 83.16(c)
of this part, the Secretary will transmit
to Congress a report providing such
change to the designation or
determination, including an iteration of
the relevant criteria, as specified under
§ 83.13(c), and a summary of the
information and findings on which the
decision is based. HHS will also publish
a notice summarizing the decision in
the Federal Register.
(e) A new designation of the Secretary
under this section will take effect 30
calendar days after the date on which
the report of the Secretary under
paragraph (d) of this section is
submitted to Congress, unless Congress
takes an action that reverses or
expedites the designation. Such new
designations and related congressional
actions will be further reported by the
Secretary pursuant to paragraphs (d)
and (e) of § 83.17.
Dated: September 13, 2005.
Michael O. Leavitt,
Secretary, Department of Health and Human
Services.
[FR Doc. 05–24358 Filed 12–21–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF THE INTERIOR
Bureau of Land Management
DATES:
Effective date December 22,
2005.
Ted
Hudson, 202–452–5042. Individuals
who use a telecommunications device
for the deaf (TDD) may contact him
individually through the Federal
Information Relay Service at 1–800–
877–8339, 24 hours a day, seven days a
week.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Background
The regulations that are the subject of
this correcting amendment have been in
effect for more than 20 years. They
pertain specifically to onshore oil and
gas operations programs, and
particularly to the penalty provision for
knowingly submitting false, misleading,
or inaccurate reports or other
information required by the regulations,
taking oil or gas from a Federal or
Indian lease without authority, or
receiving such oil or gas knowing or
having reason to know it was stolen or
unlawfully diverted or removed from a
Federal or Indian lease site.
Need for Correction
When a final rule redesignated and
revised the pertinent sections in 1987, at
52 FR 5394, it created an error in a
cross-reference. This error is misleading
and needs clarification. The provision
assigns a criminal penalty for an act for
which a civil penalty is prescribed in
another section, referring to that other
section by number. However, the
section and paragraph number stated,
section 3163.4–1(b)(6), does not exist in
the current regulations, having been
redesignated as section 3163.2(f) in the
1987 rule. The 1987 rule failed to adjust
the cross-reference, which now needs to
be corrected to eliminate confusion.
43 CFR Part 3160
List of Subjects in 43 CFR Part 3160
RIN 1004–AD80
Government contracts; Indians—
lands; Mineral royalties; Oil and gas
exploration; Penalties, Public lands—
mineral resources; Surety bonds.
Onshore Oil and Gas Operations;
Correction
Bureau of Land Management,
Interior.
ACTION: Correcting amendment.
cprice-sewell on PROD1PC66 with RULES
AGENCY:
Accordingly, 43 CFR part 3160 is
corrected by making the following
amendment:
I
SUMMARY: This document contains a
correcting amendment to a final rule
reorganizing regulations of the Bureau
of Land Management (BLM) relating to
onshore oil and gas operations, which
was published in the Federal Register of
Friday, February 20, 1987 (52 FR 5384).
The amendment corrects an error in a
cross-reference.
VerDate Aug<31>2005
15:00 Dec 21, 2005
Jkt 208001
PART 3160—ONSHORE OIL AND GAS
OPERATIONS
1. The authority citation for part 3160
continues to read as follows:
I
Authority: 25 U.S.C. 396d and 2107; 30
U.S.C. 189, 306, 359, and 1751; and 43 U.S.C.
1732(b), 1733, and 1740.
PO 00000
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Fmt 4700
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Subpart 3163—Noncompliance,
Assessments, and Penalties
2. Revise section 3163.3 to read as
follows:
I
§ 3163.3
Criminal penalties.
Any person who commits an act for
which a civil penalty is provided in
§ 3163.2(f) shall, upon conviction, be
punished by a fine of not more than
$50,000, or by imprisonment for not
more than 2 years, or both.
Dated: December 7, 2005.
Chad Calvert,
Acting Assistant Secretary of the Interior.
[FR Doc. 05–24371 Filed 12–21–05; 8:45 am]
BILLING CODE 4310–84–M
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
46 CFR Part 4
[USCG–2001–8773]
RIN 1625–AA27 (Formerly RIN 2115–AG07)
Marine Casualties and Investigations;
Chemical Testing Following Serious
Marine Incidents
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
SUMMARY: This final rule revises Coast
Guard requirements for alcohol testing
after a serious marine incident to ensure
that mariners or their employees
involved in a serious marine incident
are tested for alcohol use within 2 hours
of the occurrence of the incident as
required under the Coast Guard
Authorization Act of 1998. This final
rule also requires that most commercial
vessels have alcohol testing devices on
board, and authorizes the use of saliva
as an acceptable specimen for alcohol
testing. This rule also makes some
minor procedural changes, including a
32-hour time limit for collecting
specimens for drug testing following a
serious marine incident.
DATES: This final rule is effective June
20, 2006.
ADDRESSES: Comments and material
received from the public, as well as
documents mentioned in this preamble
as being available in the docket, are part
of docket USCG–2001–8773 and are
available for inspection or copying at
the Docket Management Facility, U.S.
Department of Transportation, room PL–
401, 400 Seventh Street SW.,
Washington, DC, between 9 a.m. and 5
p.m., Monday through Friday, except
E:\FR\FM\22DER1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 245 (Thursday, December 22, 2005)]
[Rules and Regulations]
[Pages 75949-75954]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-24358]
=======================================================================
-----------------------------------------------------------------------
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; Interim Final Rule With
Request for Comments
AGENCY: Department of Health and Human Services.
ACTION: Interim final rule with request for comments.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (``HHS'') is
amending its procedures to consider designating classes of employees to
be added to the Special Exposure Cohort under the Energy Employees
Occupational Illness Compensation Program Act of 2000 (``EEOICPA''), 42
U.S.C. 7384-7385. HHS must change these procedures to implement
amendments to EEOICPA enacted on October 28, 2004, as part of the
Ronald W. Reagan National Defense Authorization Act for Fiscal Year
2005, Public Law 108-375 (codified as amended in scattered sections of
42 U.S.C.).
DATES: Effective Date: This interim final rule is effective December
22, 2005.
Comments: The Department invites written comments on the interim
final rule from interested parties. Comments on the rule must be
received by February 21, 2006.
ADDRESSES: Address written comments on the interim final rule to the
National Institute for Occupational Safety and Health (``NIOSH'')
Docket Officer electronically by e-mail to NIOCINDOCKET@cdc.gov. See
SUPPLEMENTARY INFORMATION for file formats and other information about
electronic filing. Alternatively, submit printed comments to NIOSH
Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia
Parkway, Cincinnati, OH 45226.
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 513-533-6800 (this is not a toll free number).
Information requests can also be submitted by e-mail to OCAS@cdc.gov.
SUPPLEMENTARY INFORMATION:
I. Comments Invited
Interested persons or organizations are invited to participate in
this rulemaking by submitting written views, arguments,
recommendations, and data. Comments are invited on any topic related to
the changes in the Special Exposure Cohort (``the Cohort'') rule (42
CFR part 83) effectuated by this rulemaking. Comments concerning any
other provisions of the Cohort rule, unchanged and unaffected by this
rulemaking, will not be considered.
Comments should identify the author(s), return address, and phone
number, in case clarification is needed. Comments can be submitted by
e-mail to: NIOCINDOCKET@cdc.gov. Comments submitted by e-mail may be
provided as e-mail text or as a Word or
[[Page 75950]]
Word Perfect file attachment. Printed comments can also be submitted to
the address above. All communications received on or before the closing
date for comments will be fully considered by the Secretary. An
electronic docket containing all comments submitted will be available
over the Internet on the Web page of the National Institute for
Occupational Safety and Health (``NIOSH''), Office of Compensation
Analysis and Support at https://www.cdc.gov/niosh/ocas, and comments
will be available in writing by request.
II. Purpose of Rulemaking
On October 28, 2004, the President signed the Ronald W. Reagan
National Defense Authorization Act for Fiscal Year 2005, Public Law
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 (``EEOICPA'')
42 U.S.C. 7384-7385. Several of these amendments, under section 3166
(b), establish new statutory requirements under 42 U.S.C. 7384q and
7384l(14)(C)(ii), relevant 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 include the
following: (1) Following the receipt by NIOSH of a petition for
designation as members of the Cohort, 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 it shall be deemed that
the Secretary has submitted a report to Congress on the 31st day 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 for Congress 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.
To implement these new requirements, HHS must amend 42 CFR part 83.
As discussed below, some of the changes to the HHS rule are necessary
legally for compliance with the new requirements and other changes are
necessary to make implementation of the requirements feasible.
III. Summary of the Rule Changes
HHS has made changes to four sections of the Cohort rule to
implement the new statutory requirements summarized above. These
changes are described below in relation to the relevant statutory
requirement.
A. 180-Day Deadline for NIOSH Recommendations
HHS has amended Sec. Sec. 83.5 and 83.11 of the rule to enable
NIOSH to meet the statutory requirement that NIOSH submit to the Board
``a recommendation'' on a petition within 180 days of its receipt (see
42 U.S.C. 7384q(c)(1)). The change to Sec. 83.5 provides a definition
of a petition, which was previously undefined in the rule, to specify
that only submissions by qualified petitioners that meet the
informational and procedural requirements of a petition under the rule
will be considered to be ``petitions'' and hence will be covered by the
180-day deadline. This provision is necessary to clarify that the
submission of a petition by an unqualified petitioner or the submission
of an incomplete petition does not initiate the 180-day requirement.
NIOSH experience with petitions demonstrates that it may take months to
assist and consult with petitioners to help make incompletely submitted
petitions as complete and accurate as possible. Starting the 180-day
requirement after such preparatory work of the petitioners will help
support the completion of the NIOSH evaluation of the petition within
180-day deadline. NIOSH will provide written notification to the
submitter indicating the official date the submission qualified as a
petition, thus starting the 180-day deadline for providing a
recommendation to the Board.
The changes to Sec. 83.11 support the distinction between an
incomplete or non-qualifying submission and a petition, which is
subject to the 180-day deadline. They include the substitution of the
term ``submission'' for ``petition'' where appropriate.
HHS has also amended paragraph (c) of Sec. 83.11 to reduce, from
30 to 7 calendar days, the time during which a petitioner can request a
review of a proposed finding by NIOSH that the petition fails to meet
the specified requirements. Seven days is sufficient time for the
petitioner to make such a request and the 21 days potentially saved by
such a change are necessary to support the completion of the NIOSH
evaluation of the petition within 180 days, should the review determine
that the petition satisfies the requirements of a petition. Consistent
with this change, HHS has also amended paragraph (e) of Sec. 83.11 to
reduce, from 31 to 8 calendar days, the time at which a proposed
finding by NIOSH under paragraph (b) becomes final if no review is
conducted.
B. 30-Day Deadline for Determinations by HHS
HHS has amended Sec. Sec. 83.16 and 83.17 and added a new Sec.
83.18 of the rule to enable HHS to meet the statutory requirement that
the Secretary submit to Congress determinations as to whether or not a
class meets the statutory criteria for addition to the Cohort within 30
days of the Secretary receiving a recommendation by the Board to make
an affirmative determination in this regard (see 42 U.S.C.
7384q(c)(2)(A)-(B)). The changes to Sec. 83.16 remove the opportunity
for petitioners to seek an administrative review of proposed decisions
by the Director of NIOSH. This change is being made because it would
not be possible for the Director of NIOSH to issue a proposed decision,
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.
HHS has added provisions under a new Sec. 83.18 (the existing
Sec. 83.18 is redesignated as Sec. 83.19) to provide petitioners with
the opportunity to seek administrative reviews of final decisions by
the Secretary, since petitioners will no longer have the opportunity to
seek administrative reviews of proposed decisions. This new
administrative review opportunity is essentially identical to that
provided previously under Sec. 83.16 for proposed decisions.
Under Sec. 83.16(c) and Sec. 83.17(b), HHS has provided for the
Secretary to submit to Congress within 30 days the determinations
required under the statutory 30-day deadline.
C. Computation of Time Periods
HHS has added a new paragraph (c) ``Computation of Time Periods''
under Sec. 83.5 to specify how HHS and NIOSH will count the time
periods for the various deadlines included in the rule.
[[Page 75951]]
IV. Regulatory Procedures
HHS follows the Administrative Procedure Act (``PA'') rulemaking
procedures specified in 5 U.S.C. 553 for the development of its
regulations. In most circumstances, the APA requires a public notice
and comment period and consideration of the submitted comments prior to
promulgation of a final rule having the effect of law. However, the APA
provides for exceptions to its notice-and-comment procedures when an
agency finds that there is good cause for dispensing with such
procedures on the basis that they are impracticable, unnecessary, or
contrary to the public interest. In the case of this interim final
rule, HHS has determined that under 5 U.S.C. 553(b)(B), good cause
exists for waiving the notice and comment procedures. For these same
reasons, HHS has also determined that good cause exists under 5 U.S.C.
553(d)(3) for these interim rules to become effective immediately.
A number of courts have considered the circumstances under which an
agency can conclude that good cause exists for issuing regulations
without prior notice and comment. In American Transfer & Storage Co.,
et al. v. Interstate Commerce Commission, 719 F.2d 1283, 1295 (5th Cir.
1983), the Fifth Circuit described the impracticability test as
requiring ``analysis in practical terms of the particular statutory-
agency setting and the reasons why agency action could not await notice
and comment.'' Similarly, the Seventh Circuit noted that the
``legislative history of the impracticability standard reveals that
Congress intended this exemption to operate when the regular course of
rulemaking procedure would interfere with the agency's ability to
perform its functions with the time constraints imposed by Congress.''
United States Steel Corporation v. United States Environmental
Protection Agency, 605 F.2d 283, 287 (7th Cir. 1979).
Precisely such an ``analysis in practical terms'' demonstrates that
in this case, HHS cannot await the process of notice and comment to
implement the changes to 42 CFR part 83 set forth here on an interim
final basis. As discussed above, the amendments to EEOICPA addressed by
this rulemaking directly conflict, legally and practically, with the
existing provisions of the existing provisions of the HHS rule. The
potential consequences of these conflicts are that HHS would have to
violate the legal requirements of its rule to uphold the statutory
requirements of the EEOICPA amendments.
Specifically, under the new 30-day statutory deadline for producing
HHS determinations on petitions that the Board recommends receive
affirmative determinations (42 U.S.C. 7384q(c)(2)(A)), HHS would not be
able to produce a proposed decision, provide petitioners with the
opportunity to contest the proposed decision, and provide an
administrative review of such a challenge prior to issuing a final
decision with respect to the determination, as previously provided for
under Sec. 83.16(a)-(c) of the rule. Similarly, the reduction in the
statutorily-set congressional review period for designations by the
Secretary of additions to the Cohort, from 180 days to 30 days (42
U.S.C. 7384l(14)(C)(ii)), conflicts with Sec. 83.17(b) of the rule,
which mandates a period of 180 days before a designation by the
Secretary would become effective.
If HHS were to issue a notice of proposed rulemaking proposing
changes to the Cohort procedures, HHS would have to violate either the
new statutory requirements or its Cohort regulations for each Cohort
petition that is considered, until a final regulation could be issued.
Hence, HHS believes good cause exists to waive the notice and comment
procedures under the APA for the promulgation of this interim final
rule.
Although HHS is adopting this rule on an interim final basis, it
requests public comment on this rule. After full consideration of
public comments, HHS will publish a final rule with any necessary
changes. HHS expects to issue a final rule within six months of the
publication of this interim final rule.
V. 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 the Office of Management and Budget
(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 amendment also includes the provision of the
opportunity for certain affected parties to obtain administrative
reviews of final agency actions, versus proposed agency actions. The
revisions do not, however, 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 the Executive Order 12866. As discussed above, it does
not 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. 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 (``OL'')
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 70 FR 33590, June 8, 2005). OMB has
reviewed this rule for consistency with the President's priorities and
the principles set forth in Executive Order 12866.
[[Page 75952]]
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. This rule, 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 rule.
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 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, HHS amends 42 CFR part 83 to
read as follows:
PART 83--[AMENDED]
0
1-2. 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
0
3. Amend Sec. 83.5 by redesignating paragraphs (j) through (n) as (l)
through (p), respectively and by redesignating paragraphs (c) through
(i) as (d) through (j), respectively, and by adding new paragraphs (c)
and (k) to read as follows:
Sec. 83.5 Definition of terms used in the procedures in this part.
* * * * *
(c) Computation of Time Periods: In this Rule, all prescribed or
allowed time periods will be counted as calendar days from the business
day of receipt by the submitter(s), the petitioner(s), NIOSH, or HHS.
Receipt by NIOSH, the submitter(s) or petitioner(s) will be either the
business day of actual receipt or three (3) business days after initial
proof of mailing, whichever time period is shorter. Business days are
defined as Monday through Friday, 8 a.m. to 4:30 p.m. est and ``legal
holiday'' will be used as defined by the FED. R. CIV. P. 6(a).
* * * * *
(k) Petition means a submission under Sec. 83.8 of this part that
meets all the requirements of Sec. Sec. 83.7-83.9 of this part and has
incorporated any revisions made by the petitioner under Sec. Sec.
83.7-83.9 or Sec. 83.11 of this part.
* * * * *
Subpart C--Procedures for Adding Classes of Employees to the Cohort
0
4. Revise Sec. 83.11 to read as follows:
Sec. 83.11 What happens to petition submissions that do not satisfy
all relevant requirements under Sec. Sec. 83.7 through 83.9?
(a) NIOSH will notify the petitioner(s) of any requirement that is
not met by the submission, assist the petitioner(s) with guidance in
developing relevant information, and provide 30 calendar days for the
petitioner(s) to revise the submission accordingly.
[[Page 75953]]
(b) After 30 calendar days from the date of notification under
paragraph (a) of this section, NIOSH will notify any petitioner(s)
whose submission remains unsatisfactory of the proposed finding of
NIOSH that the submission fails to meet the specified requirements and
the basis for this finding.
(c) A petitioner may request in writing a review of a proposed
finding within 7 calendar days of notification under paragraph (b) of
this section. Petitioners must specify why the proposed finding should
be reversed, based on the petition requirements and on the information
that the petitioners had already submitted. The request may not include
any new information or documentation that was not included in the
completed submission. If the petitioner obtains new information within
this 7 day period, the petitioner should provide it to NIOSH. NIOSH
will consider this new information as a revision of the submission
under paragraph (a) of this section.
(d) Three HHS personnel, appointed by the Director of NIOSH, who
were not involved in developing the proposed finding will complete
reviews within 30 work days of the request for such a review. The
Director of NIOSH will consider the results of the review and then make
a final decision as to whether the submission satisfies the
requirements for a petition.
(e) Proposed findings established by NIOSH under paragraph (b) of
this section will become final decisions in 8 calendar days if not
reviewed under paragraph (d) of this section.
(f) Based on new information, NIOSH may, at its discretion,
reconsider a decision that a submission does not satisfy the
requirements for a petition.
0
5. Revise Sec. 83.16 to read as follows:
Sec. 83.16 How will the Secretary decide the outcome(s) of a
petition?
(a) The Director of NIOSH will propose a decision to add or deny
adding any class or classes of employees to the Cohort, including an
iteration of the relevant criteria, as specified under Sec. 83.13(c),
and a summary of the information and findings on which the proposed
decision is based. This proposed decision will take into consideration
the evaluations of NIOSH and the report and recommendations of the
Board, and may also take into consideration information presented or
submitted to the Board and the deliberations of the Board. In the case
of a petition that NIOSH has determined encompasses more than one class
of employees, the Director of NIOSH will issue a separate proposed
decision for each separate class of employees.
(b) The Secretary will make the final decision to add or deny
adding a class to the Cohort, including the definition of the class,
after considering information and recommendations provided to the
Secretary by the Director of NIOSH and the Board. HHS will transmit a
report of the decision to the petitioner(s), including an iteration of
the relevant criteria, as specified under Sec. 83.13(c), and a summary
of the information and findings on which the decision is based. HHS
will also publish a notice summarizing the decision in the Federal
Register.
(c) If, under Sec. 83.15(e), the Board recommends that the
Secretary designate a class covered by the petition as an addition to
the Cohort, and if, under paragraph (b) of Sec. 83.16, the Secretary
decides to deny adding the class, as defined by the Board, to the
Cohort, then the Secretary will submit to Congress a determination that
the statutory criteria specified under 42 U.S.C. 7384q(b)(1) and (2)
have not been met for adding the class to the Cohort. The Secretary
will submit this determination to Congress within 30 calendar days
following receipt by the Secretary of the recommendation of the Board.
0
6. Amend Sec. 83.17 by redesignating paragraphs (b), (c), and (d), as
(c), (d), and (e), respectively, and by adding new paragraph (b), and
revising newly redesignated paragraphs (c) and (e) to read as follows:
Sec. 83.17 How will the Secretary report a final decision to add a
class of employees to the Cohort and any action of Congress concerning
the effect of the final decision?
* * * * *
(b) If, under Sec. 83.15(e), the Board recommends that the
Secretary designate a class covered by the petition as an addition to
the Cohort, and if, under paragraph (b) of Sec. 83.16, the Secretary
decides to add a class to the Cohort that is inclusive of the class as
defined by the Board, then the Secretary will transmit to Congress the
report specified in paragraph (a) of this section within 30 calendar
days following receipt by the Secretary of the recommendation of the
Board.
(c) A designation of the Secretary will take effect 30 calendar
days after the date on which the report of the Secretary under
paragraph (a) of this section is submitted to Congress, or is deemed to
have been submitted to Congress,\5\ unless Congress takes an action
that reverses or expedites the designation.
---------------------------------------------------------------------------
\5\ Under 42 U.S.C. 7384q(c)(2)(C), if the Secretary does not
submit within 30 days the determination required under paragraph (a)
of Sec. 83.17 of this part, then on the following day, ``it shall
be deemed'' that the Secretary submitted the report specified under
paragraph (b) of Sec. 83.17 of this part.
---------------------------------------------------------------------------
* * * * *
(e) The report specified under paragraph (d) of this section will
be published on the Internet at https://www.cdc.gov/niosh/ocas and in
the Federal Register.
Sec. 83.18 [Redesignated as Sec. 83.19]
0
7. Redesignate Sec. 83.18 as Sec. 83.19.
0
8. Add a new Sec. 83.18 to read as follows:
Sec. 83.18 How can petitioners obtain an administrative review of a
final decision by the Secretary?
(a) HHS will allow petitioners to contest only a final decision to
deny adding a class to the Cohort or a health endangerment
determination under Sec. 83.13(c)(3)(ii). Such challenges must be
submitted in writing within 30 calendar days and must include evidence
that the final decision relies on a record of either substantial
factual errors or substantial errors in the implementation of the
procedures of this part. Challenges may not introduce new information
or documentation concerning the petition or the NIOSH or Board
evaluation(s) that was not submitted or presented by the petitioner(s)
or others to NIOSH or to the Board prior to the Board's issuing its
recommendations under Sec. 83.15.
(b) A panel of three HHS personnel, independent of NIOSH and
appointed by the Secretary, will conduct an administrative review based
on a challenge submitted under paragraph (a) of this section and
provide recommendations of the panel to the Secretary concerning the
merits of the challenge and the resolution of issues contested by the
challenge. Reviews by the panel will consider, in addition to the views
and information submitted by the petitioner(s) in the challenge, the
NIOSH evaluation report(s), the report containing the recommendations
of the Board issued under Sec. 83.15, and recommendations of the
Director of NIOSH to the Secretary. The reviews may also consider
information presented or submitted to the Board and the deliberations
of the Board prior to the issuance of the recommendations of the Board
under Sec. 83.15. The panel shall consider whether HHS substantially
complied with the procedures of this part, the factual accuracy of the
information supporting the final decision, and the principal findings
and recommendations of NIOSH and those of the Board issued under Sec.
83.15.
[[Page 75954]]
(c) The Secretary will decide whether or not to revise a final
decision contested by the petitioner(s) under this section after
considering information and recommendations provided to the Secretary
by the Director of NIOSH, the Board, and from the HHS administrative
review conducted under paragraph (b) of this section. HHS will transmit
a report of the decision to the petitioner(s).
(d) If the Secretary decides under paragraph (c) of this section to
change a designation under Sec. 83.17(a) of this part or a
determination under Sec. 83.16(c) of this part, the Secretary will
transmit to Congress a report providing such change to the designation
or determination, including an iteration of the relevant criteria, as
specified under Sec. 83.13(c), and a summary of the information and
findings on which the decision is based. HHS will also publish a notice
summarizing the decision in the Federal Register.
(e) A new designation of the Secretary under this section will take
effect 30 calendar days after the date on which the report of the
Secretary under paragraph (d) of this section is submitted to Congress,
unless Congress takes an action that reverses or expedites the
designation. Such new designations and related congressional actions
will be further reported by the Secretary pursuant to paragraphs (d)
and (e) of Sec. 83.17.
Dated: September 13, 2005.
Michael O. Leavitt,
Secretary, Department of Health and Human Services.
[FR Doc. 05-24358 Filed 12-21-05; 8:45 am]
BILLING CODE 4163-18-P
