[Federal Register Volume 70, Number 245 (Thursday, December 22, 2005)]
[Rules and Regulations]
[Pages 75949-75954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-24358]
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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.
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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 [email protected]. 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 [email protected].
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: [email protected]. 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 http://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.
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\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.
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* * * * *
(e) The report specified under paragraph (d) of this section will
be published on the Internet at http://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