[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.
---------------------------------------------------------------------------

    \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 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