Procedures for Designating Classes of Employees as Members of the Special Exposure Cohort Under the Energy Employees Occupational Illness Compensation Program Act of 2000; Amendments, 37455-37459 [E7-13233]

Download as PDF Federal Register / Vol. 72, No. 131 / Tuesday, July 10, 2007 / Rules and Regulations each ICM in view of their commercial sensitivity. We adopt the following changes to the Mailing Standards of the United States Postal Service, International Mail Manual (IMM), incorporated by reference in the Code of Federal Regulations. See 39 CFR 20.1. List of Subjects in 39 CFR Part 20 Foreign relations, International postal services. PART 20—[AMENDED] 1. The authority citation for 39 CFR Part 20 continues to read as follows: I Authority: 5 U.S.C. 552(a); 39 U.S.C. 401, 404, 407, 408. 2. Revise International Mail Manual as follows: * * * * * I 2 Conditions for Mailing * * * * * 290 Commercial Services * * * * * 297 International Customized Mail * * 297.4 * * * Postal Bulletin Notifications [Revise 297.4 as follows] Within 30 days of entering into an ICM service agreement, the Postal Service will publish the name of the customer in the Postal Bulletin. Stanley F. Mires, Chief Counsel, Legislative. [FR Doc. 07–3332 Filed 7–9–07; 8:45 am] BILLING CODE 7710–12–M DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 83 RIN 0920–AA13 Procedures for Designating Classes of Employees as Members of the Special Exposure Cohort Under the Energy Employees Occupational Illness Compensation Program Act of 2000; Amendments Department of Health and Human Services. ACTION: Final Rule. rmajette on PROD1PC64 with RULES AGENCY: SUMMARY: The Department of Health and Human Services is amending its procedures for designating classes of employees to be added to the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000 VerDate Aug<31>2005 15:13 Jul 09, 2007 Jkt 211001 (EEOICPA). The final rule adds and revises deadlines for evaluating petitions for cohort status, clarifies when time periods commence and how they toll, and provides information relevant to these deadlines on the content of petition evaluation reports. DATES: This Final Rule is effective July 10, 2007. FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of Compensation Analysis and Support, National Institute for Occupational Safety and Health, 4676 Columbia Parkway, MS–C–46, Cincinnati, OH 45226, Telephone 513–533–6825 (this is not a toll free number). Information requests can also be submitted by e-mail to OCAS@CDC.GOV. SUPPLEMENTARY INFORMATION: I. Purpose of Rulemaking On October 28, 2004, the President signed the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005, Pub. L. 108–375 (codified as amended in scattered sections of 42 U.S.C.). Division C, Subtitle E, of this Act includes amendments to the Energy Employees Occupational Illness Compensation Program Act of 2000 (‘‘EEOICPA’’), 42 U.S.C. 7384–7385. Several of these amendments, under § 3166(b), established new statutory requirements under 42 U.S.C. 7384q and 7384l(14)(C)(ii) that pertain to the Department of Health and Human Services (‘‘HHS’’) procedures established under 42 CFR part 83: ‘‘Procedures for Designating Classes of Employees as Members of the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.’’ These new requirements included the following: (1) Following the receipt of a petition for designation as members of the Special Exposure Cohort (‘‘the Cohort’’), the National Institute for Occupational Safety and Health (NIOSH) must submit ‘‘a recommendation’’ on that petition, including all documentation, to the Advisory Board on Radiation and Worker Health (‘‘the Board’’) within 180 days; (2) following the receipt by the Secretary of HHS (‘‘the Secretary’’) of a recommendation by the Board that the Secretary determine in the affirmative that a class meets the statutory criteria for addition to the Cohort, the Secretary must submit to Congress a determination as to whether or not the class meets these statutory criteria within 30 days; (3) if the Secretary does not submit this determination to Congress within 30 days, then on the 31st day it shall be deemed that the PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 37455 Secretary has submitted a report to Congress that designates, as an addition to the Cohort, the class recommended by the Board for addition to the Cohort and that provides the criteria used to support the designation; and (4) the period Congress shall have to review a report submitted by the Secretary to designate a class as an addition to the Cohort is reduced from 180 days to 30 days. The purpose of the new requirements was to expedite the evaluation and decision process for adding classes of employees to the Cohort. On December 22, 2005, HHS issued an Interim Final Rule (IFR) incorporating changes to ensure the new statutory requirements are met and requesting public comment (70 FR 75950). The public comment period for this rulemaking was initially to close on February 21, 2006. Upon a request from the Board for additional time to comment, the comment period was extended for 30 days and closed on March 23, 2006, after a total of 90 days. As discussed below, HHS has incorporated additional changes in this Final Rule in response to comments from the Board and from the public. These changes also bring the Final Rule into alignment with the Congressional recommendations specified in the Conference Report associated with the new statutory deadlines (H. Rep. 108– 767). II. Summary of Public Comments The public comment period for the IFR extended from December 22, 2005 through March 23, 2006. HHS received comments from seven parties in addition to the consensus comments of the Board. These include four individuals, one U.S. Senator, one labor organization, and one advocacy group. The comments are summarized and responded to below, together with explanations of changes HHS has incorporated into this Final Rule. A. 180-Day Deadline for NIOSH Recommendations Several commenters, including the Board, recommended that HHS reiterate in the final rule NIOSH’s 180-day statutory deadline to evaluate a petition and submit recommendations to the Board. One commenter also wanted the rule to specify what actions HHS would take if NIOSH failed to meet that deadline. In contrast, another commenter recommended against including any of the statutory deadlines in the rule because of concern that hastening the evaluation and recommendation process could prevent E:\FR\FM\10JYR1.SGM 10JYR1 37456 Federal Register / Vol. 72, No. 131 / Tuesday, July 10, 2007 / Rules and Regulations the full and fair consideration of petitions. Commenters also raised concerns about various aspects of the IFR’s petition qualification and review process. Several commenters were concerned that the rule did not include within the 180-day statutory deadline NIOSH’s process for identifying deficiencies in petitions. They said the FY05 Defense Act Conference Report (H.Rep. 108–767) indicated that Congress intended for the qualification process to be included within the 180day period, citing the following from the Report: rmajette on PROD1PC64 with RULES During the 180 day period when NIOSH is preparing the petition for review by the Advisory Board, NIOSH should identify all deficiencies in the petition * * * Most commenters, including the Board, also recommended that HHS reinstate the 30-day period for petitioners to request a review of NIOSH’s proposed finding that a petition is deficient and does not qualify for consideration. Finally, one commenter recommended that HHS clarify in the rule that NIOSH will provide a recommendation for each class of employees the petition covers. In response to those comments, HHS has made several changes in the final rule. First, HHS has added a reference to the 180-day deadline for NIOSH to evaluate petitions and submit recommendations to the Board (§ 83.13 (e)). The provisions in the IFR were designed to ensure that NIOSH would meet the deadline. Referencing the 180day deadline in the final rule identifies the goal that the earlier changes are intended to achieve. Second, HHS has revised the rule so the process of determining whether petitions are qualified is included in the 180-day period (§§ 83.5(k) and 83.11). HHS agrees with the commenters that Congress intended to include that process in the 180-day period, and the change brings the final rule into alignment with the Conference Report. As the commenters pointed out, the IFR did not include this process in the 180-day period. In the preamble to the IFR, HHS said it was necessary to exclude the process from the deadline to ensure that NIOSH had adequate time to evaluate petitions and make recommendations within the deadline. According to NIOSH, sometimes it can take months to assist and consult with petitioners to help them remedy petition deficiencies, which could significantly impact NIOSH’s ability to do a comprehensive evaluation before the deadline ended. Thus, in the IFR HHS distinguished between ‘‘submissions’’ VerDate Aug<31>2005 15:13 Jul 09, 2007 Jkt 211001 (i.e., petitions that were not yet determined to meet the requirements of §§ 83.7–83.9) and ‘‘petitions’’ (i.e., petitions that have been determined to meet the requirements) (§ 83.5(k)). The 180-day period started tolling only when NIOSH received a ‘‘petition’’ (§ 83.5(k)). In the final rule, HHS has deleted § 83.5(k) and removed the distinction between submissions and petitions in § 83.11. Third, HHS has reinstated the 30-day period for petitioners to request a review of NIOSH’s proposed finding that a petition is deficient (§ 83.11). In the IFR, HHS had reduced the request period to 7 days to increase the feasibility of NIOSH meeting the 180day deadline. To ensure that the additional time for requesting review does not prevent NIOSH from meeting the deadline, HHS is adopting the recommendation of one commenter that the clock on the 180 days start when petitioners seek and are granted a review on whether their petition satisfies all requirements. Accordingly, HHS has added new paragraph (e) to § 83.13 specifying that the 180-day period shall not include any days during which (1) the petitioner is revising the petition to remedy deficiencies NIOSH identified, (2) the petitioner requests a review of NIOSH’s proposed finding that the petition does not meet all relevant requirements, or (3) the three-person HHS panel (as authorized by § 83.11(d)) is reviewing the petitioner’s request. Finally, HHS has revised § 83.13(d)(4) to clarify that NIOSH evaluation report findings to the Board must specify whether it is ‘‘feasible’’ to estimate radiation doses with sufficient accuracy ‘‘for each class defined in the report.’’ HHS is adding this specification because NIOSH sometimes finds a Cohort petition covers more than one class of employees even though it is submitted on behalf of a single class. For example, in some cases, NIOSH will find differences in radiation exposures and record availability for different employee groups at the same facility. Consequently, NIOSH evaluation reports may need to define more than one class of employees in the petition and provide separate findings concerning each class. In light of NIOSH’s 180-day deadline, HHS has also added language to paragraph (d)(4) indicating that NIOSH’s evaluation report must include a feasibility finding about whether radiation doses for each class of employees can be estimated with sufficient accuracy. HHS did not adopt every recommendation commenters made. HHS has not incorporated PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 recommendations that NIOSH inform petitioners of all deficiencies within the first 30 days (H. Rep. 108–767). HHS believes the recommendation is not necessary. The changes in the final rule specifying that the 180-day period begins when NIOSH receives a petition gives the Agency more than adequate incentive to identify very quickly whether the petition qualifies for consideration or has deficiencies. Also, HHS has not adopted the recommendation to add requirements to the final rule specifying the actions HHS would take if NIOSH failed to meet the 180-day deadline. HHS fully understands the EEOICPA statutory amendments stressing the importance of evaluating petitions in a timely manner. Although there may be complex circumstances of radiation exposure or records availability or exceptional instances when it may be challenging to complete a comprehensive evaluation covering all of the classes of employees included in petition within 180 days, HHS will make every effort to meet the deadline. The NIOSH Web page at http:www.cdc.gov/NIOSH/ocas will continuously track the progress of each active petition for the interested public. B. Resubmission of Petitions Based on New Information Two commenters indicated confusion concerning whether a petitioner could submit a petition on behalf of a class of employees subsequent to NIOSH finding that a prior petition covering the class did not meet the petition requirements. The commenters believed that § 83.11(f) only permitted NIOSH, upon its own discretion, to consider a petition for a class of employees for which a prior petition had already been found to not meet petition requirements. Nothing in the rule would prevent a petitioner from submitting a subsequent petition based on new information. Such a petition would be evaluated by NIOSH as a new petition. HHS has amended § 83.11, adding paragraph (g), to clarify that petitioners may submit an additional petition for a class of employees, based on new information, subsequent to NIOSH finding that a petition does not meet the petition requirements specified in §§ 83.7—83.9. The existing paragraph (f) of § 83.11 has a different purpose. It is intended to allow NIOSH to reconsider a petition that it found to not meet petition requirements, based on new information NIOSH might obtain from any source, irrespective of any further action of the petitioner. E:\FR\FM\10JYR1.SGM 10JYR1 Federal Register / Vol. 72, No. 131 / Tuesday, July 10, 2007 / Rules and Regulations C. Deadline for the Chair of the Board To Submit the Cohort Petition Recommendations of the Board One commenter recommended that HHS regulate the current policy of the Board that requires the Chair to submit recommendations of the Board on the outcome of Cohort petitions to the Secretary within 21 days of the Board’s consensus formulation and approval of the recommendations. HHS has not incorporated this Board policy into the rule. Doing so would violate the Administrative Procedure Act (‘‘APA’’) rulemaking procedures specified in 5 U.S.C. 553 for the development of regulations. The APA requires that the regulating agency both provide the public with the opportunity for notice and comment and consider submitted comments prior to promulgation of a final rule. The change proposed by the commenter is not a reasonably foreseeable outcome of the changes discussed in the IFR and making such a change would not offer the public adequate notice of the change. Furthermore, HHS does not consider it necessary or appropriate to regulate this currently self-imposed policy of the Board. It is within the Board’s prerogative, with the guidance of the Designated Federal Official, to set and manage its own deadlines. rmajette on PROD1PC64 with RULES D. Review of Proposed and Final Decisions of HHS on the Outcome of Cohort Petitions One commenter recommended HHS reinstate the opportunity for petitioners to seek reviews of the proposed decisions on the outcome of petitions, issued by the Director of NIOSH under § 83.16(a), prior to the issuance of final decisions by the Secretary of HHS. As discussed in the preamble of the IFR (70 FR 75950, December 22, 2005), it is not possible for petitioners to seek and HHS to provide an administrative review of the proposed decision, and for the Secretary to issue a final decision, all within the 30-day Congressional report deadline. For this reason, the administrative review opportunity of petitioners was preserved but moved in the sequence of HHS actions to follow, rather than precede, the Secretary’s final decision. Another commenter questioned whether the Secretary has discretion in responding to an HHS administrative review of a final decision and whether petitioners must seek such an administrative review as a prerequisite to obtaining a judicial review of a final decision of the Secretary issued under § 83.17. VerDate Aug<31>2005 15:13 Jul 09, 2007 Jkt 211001 Under § 83.18(c), the Secretary retains the discretion to decide the outcome of a petition, after obtaining and considering the information provided by the HHS administrative review. The authority to decide the outcome of petitions was statutorily assigned to the President (42 U.S.C. 7384q) and delegated to the Secretary by Executive Order 13179. The Secretary’s decision to add or deny adding a class to the Cohort is final unless he revises the decision pursuant to an administrative review under § 83.18 or Congress takes other action. This administrative review is optional; neither EEOICPA nor this regulation requires it as a prerequisite to judicial review. E. Protection of the Personal Information of the Petitioner One commenter recommended requiring that NIOSH disclose the identities and contact information of petitioners. The commenter reasoned that since the petitioner is acting on behalf of a class of employees, the petitioner should not have the right to privacy. The IFR did not propose imposing such a requirement on NIOSH or petitioners in this Final Rule. Instead, HHS would first have to provide public notice, the opportunity for public comment, and consideration of comments submitted, as required for rulemaking under the APA. Moreover, the recommendation to require petitioners or NIOSH to disclose the identity and contact information of the petitioners is contrary to the customary protection afforded by the Federal government to members of the public under the Privacy Act (5 U.S.C. 552a). In particular, 5 U.S.C. 552a(b) bars agencies (subject to certain exceptions not applicable here) from disclosing records such as those at issue in the recommendation, where petitioner information is ‘‘contained in a system of records’’ that allows retrieval of such records by unique person-specific identifiers, ‘‘to any person, or to another agency’’ without the individual’s written request or prior written consent. In addition, there does not appear to be a substantial justification or benefit to requiring the disclosure of the identity and contact information of the petitioner. A petitioner should not have to choose between acting on his or her own behalf, as a member or a survivor of a member of the class of employees represented in the petition, and his or her right to privacy. It is true that the class of employees includes other individuals who would also benefit PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 37457 from an affirmative decision on the petition by the Secretary, but any other member of the class of employees covered by the petition can obtain the same rights as the petitioner by submitting a valid petition, meeting the requirements specified under §§ 83.7– 83.9, on behalf of the same class of employees. F. Authority and Deadline for the Secretary To Decide on Petitions Two commenters appeared to have misunderstood the statutory requirement that the President render a decision regarding the addition of a class of employees to the Cohort within 30 days of the Board having recommended its addition (see 42 U.S.C. 7384q(c)(2)(A)–(B)) to newly authorize the President’s involvement in these decisions. One commenter recommended that the President not be given the role of making such decisions, and the second commenter recommended that the President not be provided 30 days to make such decisions, as the commenter believed this would prolong the decision-making process. Since EEOICPA was originally enacted in 2000, the President has been solely authorized in the statute to decide whether or not to designate classes of employees for addition to the Cohort. The President delegated this authority to the Secretary, who has implemented this authority ever since. The only change made by the statutory requirement discussed above is to impose a 30-day deadline on the President to make such decisions in certain cases. As discussed in the IFR, this 30-day deadline applies to the Secretary’s decisions, since the President delegated this decisionmaking authority to the Secretary. The deadline does not prolong the decisionmaking process since, prior to this statutory requirement, the Secretary was not under any deadline to make such decisions. G. Non-Regulatory Comments HHS received several comments that do not pertain to the IFR. These included a comment to add a class of employees from the Hanford facility to the Cohort, a personal perspective on the history of the management of the U.S. nuclear weapons program, concerns about the involvement of the Office of Management and Budget (‘‘OMB’’) in the program, and a speculation that adding classes of employees to the Cohort would be costsaving compared to the conduct of dose reconstructions. E:\FR\FM\10JYR1.SGM 10JYR1 37458 Federal Register / Vol. 72, No. 131 / Tuesday, July 10, 2007 / Rules and Regulations The Board recommended NIOSH provide petitioners with guidance in the form of a timeline for the petition process, to ensure petitioners understand the expected duration of the entire process and its elements, from the submission of a petition to the point at which final decisions on a petition become effective. NIOSH will provide each petitioner with such guidance, together with other introductory materials provided to petitioners upon the receipt by NIOSH of a petition. One commenter suggested all cancers be added to the list of 22 ‘‘specified cancers’’ covered for members of the Cohort. The list of specified cancers covered for members of the Cohort is established statutorily under EEOICPA and not governed by this rulemaking. EEOICPA states: The term ‘‘specified cancer’’ means any of the following: (A) A specified disease, as that term is defined in section 4(b)(2) of the Radiation Exposure Compensation Act (42 U.S.C. 2210 note). (B) Bone cancer. (C) Renal cancers. (D) Leukemia (other than chronic lymphocytic leukemia), if initial occupational exposure occurred before 21 years of age and onset occurred more than two years after initial occupational exposure. 42 U.S.C. 7384l(17) III. Regulatory Assessment Requirements rmajette on PROD1PC64 with RULES A. Executive Order 12866 Under Executive Order 12866 (58 FR 51735, October 4, 1993), the agency must determine whether a regulatory action is ‘‘significant’’ and therefore subject to review by OMB and the requirements of the Executive Order. Under section 3(f), the order defines a ‘‘significant regulatory action’’ as an action that is likely to result in a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities (also referred to as ‘‘economically significant’’); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in the executive order. VerDate Aug<31>2005 15:13 Jul 09, 2007 Jkt 211001 This rule is being treated as a ‘‘significant regulatory action’’ within the meaning of the executive order because it meets the criterion of Section 3(f)(4) in that it raises novel or legal policy issues arising out of the legal mandate established by EEOICPA. It amends current procedures by which the Secretary considers petitions to add classes of employees to the Cohort to comport with new statutory deadlines (see 42 U.S.C. 7384q(c)(2)(A) and 42 U.S.C. 7384l(14)(C)(ii)). The revisions, however, neither affect the financial cost to the federal government of responding to these petitions nor the scientific and policy bases for making decisions on such petitions. The rule carefully explains the manner in which the procedures are consistent with the mandates of 42 U.S.C. 7384q and 7384l(14)(C)(ii) and implements the detailed requirements of these sections. The rule does not interfere with State, local, and tribal governments in the exercise of their governmental functions. The rule is not considered economically significant, as defined in § 3(f)(1) of Executive Order 12866. As discussed above, it does not affect the financial cost to the federal government of responding to these petitions nor does it affect the scientific and policy bases for making decisions on such petitions. Furthermore, it has a subordinate role in the adjudication of claims under EEOICPA, serving as one element of an adjudication process administered by the Department of Labor (‘‘DOL’’) under 20 CFR parts 1 and 30. DOL has determined that its rule fulfills the requirements of Executive Order 12866 and provides estimates of the aggregate cost of benefits and administrative expenses of implementing EEOICPA under its rule (see 71 FR 78520, December 29, 2006). OMB has reviewed this rule for consistency with the President’s priorities and the principles set forth in Executive Order 12866. B. Regulatory Flexibility Act The Regulatory Flexibility Act (‘‘RFA’’), 5 U.S.C. 601 et. seq., requires each agency to consider the potential impact of its regulations on small entities, including small businesses, small governmental units, and small not-for-profit organizations. HHS certifies that this rule will not have a significant economic impact on a substantial number of small entities within the meaning of the RFA. The rule affects only HHS, DOL, the Department of Energy, and certain individuals covered by EEOICPA. Therefore, a PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 regulatory flexibility analysis as provided for under RFA is not required. C. What Are the Paperwork and Other Information Collection Requirements (Subject to the Paperwork Reduction Act) Imposed Under This Rule? The Paperwork Reduction Act (‘‘PRA’’) 44 U.S.C. 3501 et seq., requires an agency to invite public comment on and to obtain OMB approval of any regulation that requires ten or more people to report information to the agency or to keep certain records. The Special Exposure Cohort rule, 42 CFR part 83, which requires the collection of information from petitioners, is covered by the PRA and has received OMB clearance (OMB control #0920–0639). However, this rulemaking, which makes limited changes to 42 CFR part 83, does not contain any information collection requirements. Thus, HHS has determined that the PRA does not apply to this rulemaking. D. Small Business Regulatory Enforcement Fairness Act As required by Congress under the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), HHS will report to Congress promulgation of this rule prior to its taking effect. The report will state that HHS has concluded that this rule is not a ‘‘major rule’’ because it is not likely to result in an annual effect on the economy of $100 million or more. However, this rule has a subordinate role in the adjudication of claims under EEOICPA, serving as one element of an adjudication process administered by DOL under 20 CFR parts 1 and 30. DOL has determined that its rule is a ‘‘major rule’’ because it will likely result in an annual effect on the economy of $100 million or more. E. Unfunded Mandates Reform Act of 1995 Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 et seq.) directs agencies to assess the effects of federal regulatory actions on State, local, and tribal governments and the private sector ‘‘other than to the extent that such regulations incorporate requirements specifically set forth in law.’’ For purposes of the Unfunded Mandates Reform Act, this rule does not include any federal mandate that may result in increased annual expenditures in excess of $100 million by state, local or tribal governments in the aggregate, or by the private sector. F. Executive Order 12988 (Civil Justice) This rule has been drafted and reviewed in accordance with Executive E:\FR\FM\10JYR1.SGM 10JYR1 Federal Register / Vol. 72, No. 131 / Tuesday, July 10, 2007 / Rules and Regulations Order 12988 on Civil Justice Reform and will not unduly burden the federal court system. HHS adverse decisions may be reviewed in United States District Courts pursuant to the APA. HHS has attempted to minimize that burden by providing petitioners an opportunity to seek administrative review of adverse decisions. HHS has provided a clear legal standard it will apply in considering petitions. This rule has been reviewed carefully to eliminate drafting errors and ambiguities. G. Executive Order 13132 (Federalism) HHS has reviewed this rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have ‘‘federalism implications.’’ The rule does not ‘‘have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.’’ H. Executive Order 13045 (Protection of Children From Environmental, Health Risks and Safety Risks) In accordance with Executive Order 13045, HHS has evaluated the environmental health and safety effects of this rule on children. HHS has determined that the rule would have no effect on children. I. Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use) In accordance with Executive Order 13211, HHS has evaluated the effects of this rule on energy supply, distribution or use, and has determined that the rule will not have a significant adverse effect on them. rmajette on PROD1PC64 with RULES J. Effective Date The Secretary has determined, pursuant to 5 U.S.C. 553(d)(3), that there is good cause for this rule to be effective immediately to eliminate legal inconsistencies between new statutory requirements under 42 U.S.C. 7384l and 7384q and regulatory requirements under 42 CFR part 83 and to make the implementation of the new statutory requirements feasible. List of Subjects in 42 CFR Part 83 Government employees, Occupational safety and health, Nuclear materials, Radiation protection, Radioactive materials, Workers’ compensation. Text of the Rule For the reasons discussed in the preamble, the interim rule amending 42 I VerDate Aug<31>2005 15:13 Jul 09, 2007 Jkt 211001 CFR part 83, published on December 22, 2005 (70 FR 75950), is confirmed as final with the folling changes: PART 83—[AMENDED] 1. The authority citation for part 83 continues to read as follows: I Authority: 42 U.S.C. 7384q; E.O. 13179, 65 FR 77487, 3 CFR, 2000 Comp., p. 321. Subpart B—Definitions § 83.5 [Amended] 2. Amend § 83.5 by removing paragraph (k) and redesignating paragraphs (l) through (p) as paragraphs (k) through (o), respectively. I Subpart C—Procedures for Adding Classes of Employees to the Cohort 3. Amend § 83.11 as follows: A. By revising the section heading. B. By replacing the term ‘‘submission’’ with the term ‘‘petition’’ in paragraphs (a) through (d) and (f). I C. By replacing the phrases ‘‘7 calendar days’’ and ‘‘7 day period’’ with ‘‘30 calendar days’’ and ‘‘30-day period’’, respectively, in paragraph (c). I D. By replacing ‘‘8 calendar days’’ with ‘‘31 calendar days’’ in paragraph (e). I E. By adding a new paragraph (g) to read as follows: I I I § 83.11 What happens to petitions that do not satisfy all relevant requirements under §§ 83.7 through 83.9? * * * * * (g) A petitioner whose petition has been found not to satisfy the requirements for a petition under either paragraph (d) or (e) of this section may submit to NIOSH a new petition for the identical class of employees at any time thereafter on the basis of new information not provided to NIOSH in the original petition. In such a case, the petitioner is required to fully re-address all the requirements of §§ 83.7–83.9 in the petition. I 4. Amend § 83.13 by revising paragraph (d)(4) and adding paragraph (e) to read as follows: § 83.13 How will NIOSH evaluate petitions, other than petitions by claimants covered under § 83.14? * * * * * (d)(4) A summary of the findings concerning the adequacy of existing records and information for reconstructing doses for individual members of the class under the methods of 42 CFR part 82 specifying, for each class defined in the report, whether NIOSH finds that it is feasible to estimate the radiation doses of members PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 37459 of the class with sufficient accuracy, and a description of the evaluation methods and information upon which these findings are based; and * * * * * (e) The NIOSH report under paragraph (d) of this section shall be completed within 180 calendar days of the receipt of the petition by NIOSH. The procedure for computing this time period is specified in § 83.5(c). In addition, the computing of 180 calendar days shall not include any days during which the petitioner may be revising the petition to remedy deficiencies identified by NIOSH under § 83.11(a) or (b), nor shall it include any days during which the petitioner may request a review of a proposed finding under § 83.11(c) or during the conduct of such a review under § 83.11(d). Dated: March 16, 2007. Michael O. Leavitt, Secretary, Department of Health and Human Services. Editorial Note: This document was received in the Office of the Federal Register on July 3, 2007. [FR Doc. E7–13233 Filed 7–9–07; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 16 RIN 1018–AT29 Injurious Wildlife Species; Silver Carp (Hypophthalmichthys molitrix) and Largescale Silver Carp (Hypophthalmichthys harmandi) Fish and Wildlife Service, Interior. ACTION: Final rule. AGENCY: SUMMARY: The U.S. Fish and Wildlife Service (Service or we) adds all forms of live silver carp (Hypophthalmichthys molitrix), gametes, viable eggs, and hybrids; and all forms of live largescale silver carp (Hypophthalmichthys harmandi), gametes, viable eggs, and hybrids to the list of injurious fish, mollusks, and crustaceans under the Lacey Act. The best available information indicates that this action is necessary to protect the interests of human beings, and wildlife and wildlife resources, from the purposeful or accidental introduction, and subsequent establishment, of silver carp and largescale silver carp populations in ecosystems of the United States. Live silver carp and largescale silver carp, gametes, viable eggs, and hybrids can be E:\FR\FM\10JYR1.SGM 10JYR1

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[Federal Register Volume 72, Number 131 (Tuesday, July 10, 2007)]
[Rules and Regulations]
[Pages 37455-37459]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13233]


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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

AGENCY: Department of Health and Human Services.

ACTION: Final Rule.

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SUMMARY: The Department of Health and Human Services is amending its 
procedures for designating classes of employees to be added to the 
Special Exposure Cohort under the Energy Employees Occupational Illness 
Compensation Program Act of 2000 (EEOICPA). The final rule adds and 
revises deadlines for evaluating petitions for cohort status, clarifies 
when time periods commence and how they toll, and provides information 
relevant to these deadlines on the content of petition evaluation 
reports.

DATES: This Final Rule is effective July 10, 2007.

FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of 
Compensation Analysis and Support, National Institute for Occupational 
Safety and Health, 4676 Columbia Parkway, MS-C-46, Cincinnati, OH 
45226, Telephone 513-533-6825 (this is not a toll free number). 
Information requests can also be submitted by e-mail to OCAS@CDC.GOV.

SUPPLEMENTARY INFORMATION: 

I. Purpose of Rulemaking

    On October 28, 2004, the President signed the Ronald W. Reagan 
National Defense Authorization Act for Fiscal Year 2005, Pub. L. 108-
375 (codified as amended in scattered sections of 42 U.S.C.). Division 
C, Subtitle E, of this Act includes amendments to the Energy Employees 
Occupational Illness Compensation Program Act of 2000 (``EEOICPA''), 42 
U.S.C. 7384-7385. Several of these amendments, under Sec.  3166(b), 
established new statutory requirements under 42 U.S.C. 7384q and 
7384l(14)(C)(ii) that pertain to the Department of Health and Human 
Services (``HHS'') procedures established under 42 CFR part 83: 
``Procedures for Designating Classes of Employees as Members of the 
Special Exposure Cohort under the Energy Employees Occupational Illness 
Compensation Program Act of 2000.'' These new requirements included the 
following: (1) Following the receipt of a petition for designation as 
members of the Special Exposure Cohort (``the Cohort''), the National 
Institute for Occupational Safety and Health (NIOSH) must submit ``a 
recommendation'' on that petition, including all documentation, to the 
Advisory Board on Radiation and Worker Health (``the Board'') within 
180 days; (2) following the receipt by the Secretary of HHS (``the 
Secretary'') of a recommendation by the Board that the Secretary 
determine in the affirmative that a class meets the statutory criteria 
for addition to the Cohort, the Secretary must submit to Congress a 
determination as to whether or not the class meets these statutory 
criteria within 30 days; (3) if the Secretary does not submit this 
determination to Congress within 30 days, then on the 31st day it shall 
be deemed that the Secretary has submitted a report to Congress that 
designates, as an addition to the Cohort, the class recommended by the 
Board for addition to the Cohort and that provides the criteria used to 
support the designation; and (4) the period Congress shall have to 
review a report submitted by the Secretary to designate a class as an 
addition to the Cohort is reduced from 180 days to 30 days.
    The purpose of the new requirements was to expedite the evaluation 
and decision process for adding classes of employees to the Cohort.
    On December 22, 2005, HHS issued an Interim Final Rule (IFR) 
incorporating changes to ensure the new statutory requirements are met 
and requesting public comment (70 FR 75950). The public comment period 
for this rulemaking was initially to close on February 21, 2006. Upon a 
request from the Board for additional time to comment, the comment 
period was extended for 30 days and closed on March 23, 2006, after a 
total of 90 days.
    As discussed below, HHS has incorporated additional changes in this 
Final Rule in response to comments from the Board and from the public. 
These changes also bring the Final Rule into alignment with the 
Congressional recommendations specified in the Conference Report 
associated with the new statutory deadlines (H. Rep. 108-767).

II. Summary of Public Comments

    The public comment period for the IFR extended from December 22, 
2005 through March 23, 2006. HHS received comments from seven parties 
in addition to the consensus comments of the Board. These include four 
individuals, one U.S. Senator, one labor organization, and one advocacy 
group. The comments are summarized and responded to below, together 
with explanations of changes HHS has incorporated into this Final Rule.

A. 180-Day Deadline for NIOSH Recommendations

    Several commenters, including the Board, recommended that HHS 
reiterate in the final rule NIOSH's 180-day statutory deadline to 
evaluate a petition and submit recommendations to the Board. One 
commenter also wanted the rule to specify what actions HHS would take 
if NIOSH failed to meet that deadline. In contrast, another commenter 
recommended against including any of the statutory deadlines in the 
rule because of concern that hastening the evaluation and 
recommendation process could prevent

[[Page 37456]]

the full and fair consideration of petitions.
    Commenters also raised concerns about various aspects of the IFR's 
petition qualification and review process. Several commenters were 
concerned that the rule did not include within the 180-day statutory 
deadline NIOSH's process for identifying deficiencies in petitions. 
They said the FY05 Defense Act Conference Report (H.Rep. 108-767) 
indicated that Congress intended for the qualification process to be 
included within the 180-day period, citing the following from the 
Report:

    During the 180 day period when NIOSH is preparing the petition 
for review by the Advisory Board, NIOSH should identify all 
deficiencies in the petition * * *

    Most commenters, including the Board, also recommended that HHS 
reinstate the 30-day period for petitioners to request a review of 
NIOSH's proposed finding that a petition is deficient and does not 
qualify for consideration. Finally, one commenter recommended that HHS 
clarify in the rule that NIOSH will provide a recommendation for each 
class of employees the petition covers.
    In response to those comments, HHS has made several changes in the 
final rule. First, HHS has added a reference to the 180-day deadline 
for NIOSH to evaluate petitions and submit recommendations to the Board 
(Sec.  83.13 (e)). The provisions in the IFR were designed to ensure 
that NIOSH would meet the deadline. Referencing the 180-day deadline in 
the final rule identifies the goal that the earlier changes are 
intended to achieve.
    Second, HHS has revised the rule so the process of determining 
whether petitions are qualified is included in the 180-day period 
(Sec. Sec.  83.5(k) and 83.11). HHS agrees with the commenters that 
Congress intended to include that process in the 180-day period, and 
the change brings the final rule into alignment with the Conference 
Report.
    As the commenters pointed out, the IFR did not include this process 
in the 180-day period. In the preamble to the IFR, HHS said it was 
necessary to exclude the process from the deadline to ensure that NIOSH 
had adequate time to evaluate petitions and make recommendations within 
the deadline. According to NIOSH, sometimes it can take months to 
assist and consult with petitioners to help them remedy petition 
deficiencies, which could significantly impact NIOSH's ability to do a 
comprehensive evaluation before the deadline ended. Thus, in the IFR 
HHS distinguished between ``submissions'' (i.e., petitions that were 
not yet determined to meet the requirements of Sec. Sec.  83.7-83.9) 
and ``petitions'' (i.e., petitions that have been determined to meet 
the requirements) (Sec.  83.5(k)). The 180-day period started tolling 
only when NIOSH received a ``petition'' (Sec.  83.5(k)). In the final 
rule, HHS has deleted Sec.  83.5(k) and removed the distinction between 
submissions and petitions in Sec.  83.11.
    Third, HHS has reinstated the 30-day period for petitioners to 
request a review of NIOSH's proposed finding that a petition is 
deficient (Sec.  83.11). In the IFR, HHS had reduced the request period 
to 7 days to increase the feasibility of NIOSH meeting the 180-day 
deadline. To ensure that the additional time for requesting review does 
not prevent NIOSH from meeting the deadline, HHS is adopting the 
recommendation of one commenter that the clock on the 180 days start 
when petitioners seek and are granted a review on whether their 
petition satisfies all requirements. Accordingly, HHS has added new 
paragraph (e) to Sec.  83.13 specifying that the 180-day period shall 
not include any days during which (1) the petitioner is revising the 
petition to remedy deficiencies NIOSH identified, (2) the petitioner 
requests a review of NIOSH's proposed finding that the petition does 
not meet all relevant requirements, or (3) the three-person HHS panel 
(as authorized by Sec.  83.11(d)) is reviewing the petitioner's 
request.
    Finally, HHS has revised Sec.  83.13(d)(4) to clarify that NIOSH 
evaluation report findings to the Board must specify whether it is 
``feasible'' to estimate radiation doses with sufficient accuracy ``for 
each class defined in the report.'' HHS is adding this specification 
because NIOSH sometimes finds a Cohort petition covers more than one 
class of employees even though it is submitted on behalf of a single 
class. For example, in some cases, NIOSH will find differences in 
radiation exposures and record availability for different employee 
groups at the same facility. Consequently, NIOSH evaluation reports may 
need to define more than one class of employees in the petition and 
provide separate findings concerning each class. In light of NIOSH's 
180-day deadline, HHS has also added language to paragraph (d)(4) 
indicating that NIOSH's evaluation report must include a feasibility 
finding about whether radiation doses for each class of employees can 
be estimated with sufficient accuracy.
    HHS did not adopt every recommendation commenters made. HHS has not 
incorporated recommendations that NIOSH inform petitioners of all 
deficiencies within the first 30 days (H. Rep. 108-767). HHS believes 
the recommendation is not necessary. The changes in the final rule 
specifying that the 180-day period begins when NIOSH receives a 
petition gives the Agency more than adequate incentive to identify very 
quickly whether the petition qualifies for consideration or has 
deficiencies.
    Also, HHS has not adopted the recommendation to add requirements to 
the final rule specifying the actions HHS would take if NIOSH failed to 
meet the 180-day deadline. HHS fully understands the EEOICPA statutory 
amendments stressing the importance of evaluating petitions in a timely 
manner. Although there may be complex circumstances of radiation 
exposure or records availability or exceptional instances when it may 
be challenging to complete a comprehensive evaluation covering all of 
the classes of employees included in petition within 180 days, HHS will 
make every effort to meet the deadline. The NIOSH Web page at 
http:www.cdc.gov/NIOSH/ocas will continuously track the progress of 
each active petition for the interested public.

B. Resubmission of Petitions Based on New Information

    Two commenters indicated confusion concerning whether a petitioner 
could submit a petition on behalf of a class of employees subsequent to 
NIOSH finding that a prior petition covering the class did not meet the 
petition requirements. The commenters believed that Sec.  83.11(f) only 
permitted NIOSH, upon its own discretion, to consider a petition for a 
class of employees for which a prior petition had already been found to 
not meet petition requirements.
    Nothing in the rule would prevent a petitioner from submitting a 
subsequent petition based on new information. Such a petition would be 
evaluated by NIOSH as a new petition. HHS has amended Sec.  83.11, 
adding paragraph (g), to clarify that petitioners may submit an 
additional petition for a class of employees, based on new information, 
subsequent to NIOSH finding that a petition does not meet the petition 
requirements specified in Sec. Sec.  83.7--83.9.
    The existing paragraph (f) of Sec.  83.11 has a different purpose. 
It is intended to allow NIOSH to reconsider a petition that it found to 
not meet petition requirements, based on new information NIOSH might 
obtain from any source, irrespective of any further action of the 
petitioner.

[[Page 37457]]

C. Deadline for the Chair of the Board To Submit the Cohort Petition 
Recommendations of the Board

    One commenter recommended that HHS regulate the current policy of 
the Board that requires the Chair to submit recommendations of the 
Board on the outcome of Cohort petitions to the Secretary within 21 
days of the Board's consensus formulation and approval of the 
recommendations.
    HHS has not incorporated this Board policy into the rule. Doing so 
would violate the Administrative Procedure Act (``APA'') rulemaking 
procedures specified in 5 U.S.C. 553 for the development of 
regulations. The APA requires that the regulating agency both provide 
the public with the opportunity for notice and comment and consider 
submitted comments prior to promulgation of a final rule. The change 
proposed by the commenter is not a reasonably foreseeable outcome of 
the changes discussed in the IFR and making such a change would not 
offer the public adequate notice of the change.
    Furthermore, HHS does not consider it necessary or appropriate to 
regulate this currently self-imposed policy of the Board. It is within 
the Board's prerogative, with the guidance of the Designated Federal 
Official, to set and manage its own deadlines.

D. Review of Proposed and Final Decisions of HHS on the Outcome of 
Cohort Petitions

    One commenter recommended HHS reinstate the opportunity for 
petitioners to seek reviews of the proposed decisions on the outcome of 
petitions, issued by the Director of NIOSH under Sec.  83.16(a), prior 
to the issuance of final decisions by the Secretary of HHS.
    As discussed in the preamble of the IFR (70 FR 75950, December 22, 
2005), it is not possible for petitioners to seek and HHS to provide an 
administrative review of the proposed decision, and for the Secretary 
to issue a final decision, all within the 30-day Congressional report 
deadline. For this reason, the administrative review opportunity of 
petitioners was preserved but moved in the sequence of HHS actions to 
follow, rather than precede, the Secretary's final decision.
    Another commenter questioned whether the Secretary has discretion 
in responding to an HHS administrative review of a final decision and 
whether petitioners must seek such an administrative review as a 
prerequisite to obtaining a judicial review of a final decision of the 
Secretary issued under Sec.  83.17.
    Under Sec.  83.18(c), the Secretary retains the discretion to 
decide the outcome of a petition, after obtaining and considering the 
information provided by the HHS administrative review. The authority to 
decide the outcome of petitions was statutorily assigned to the 
President (42 U.S.C. 7384q) and delegated to the Secretary by Executive 
Order 13179.
    The Secretary's decision to add or deny adding a class to the 
Cohort is final unless he revises the decision pursuant to an 
administrative review under Sec.  83.18 or Congress takes other action. 
This administrative review is optional; neither EEOICPA nor this 
regulation requires it as a prerequisite to judicial review.

E. Protection of the Personal Information of the Petitioner

    One commenter recommended requiring that NIOSH disclose the 
identities and contact information of petitioners. The commenter 
reasoned that since the petitioner is acting on behalf of a class of 
employees, the petitioner should not have the right to privacy.
    The IFR did not propose imposing such a requirement on NIOSH or 
petitioners in this Final Rule. Instead, HHS would first have to 
provide public notice, the opportunity for public comment, and 
consideration of comments submitted, as required for rulemaking under 
the APA.
    Moreover, the recommendation to require petitioners or NIOSH to 
disclose the identity and contact information of the petitioners is 
contrary to the customary protection afforded by the Federal government 
to members of the public under the Privacy Act (5 U.S.C. 552a). In 
particular, 5 U.S.C. 552a(b) bars agencies (subject to certain 
exceptions not applicable here) from disclosing records such as those 
at issue in the recommendation, where petitioner information is 
``contained in a system of records'' that allows retrieval of such 
records by unique person-specific identifiers, ``to any person, or to 
another agency'' without the individual's written request or prior 
written consent.
    In addition, there does not appear to be a substantial 
justification or benefit to requiring the disclosure of the identity 
and contact information of the petitioner. A petitioner should not have 
to choose between acting on his or her own behalf, as a member or a 
survivor of a member of the class of employees represented in the 
petition, and his or her right to privacy. It is true that the class of 
employees includes other individuals who would also benefit from an 
affirmative decision on the petition by the Secretary, but any other 
member of the class of employees covered by the petition can obtain the 
same rights as the petitioner by submitting a valid petition, meeting 
the requirements specified under Sec. Sec.  83.7-83.9, on behalf of the 
same class of employees.

F. Authority and Deadline for the Secretary To Decide on Petitions

    Two commenters appeared to have misunderstood the statutory 
requirement that the President render a decision regarding the addition 
of a class of employees to the Cohort within 30 days of the Board 
having recommended its addition (see 42 U.S.C. 7384q(c)(2)(A)-(B)) to 
newly authorize the President's involvement in these decisions. One 
commenter recommended that the President not be given the role of 
making such decisions, and the second commenter recommended that the 
President not be provided 30 days to make such decisions, as the 
commenter believed this would prolong the decision-making process.
    Since EEOICPA was originally enacted in 2000, the President has 
been solely authorized in the statute to decide whether or not to 
designate classes of employees for addition to the Cohort. The 
President delegated this authority to the Secretary, who has 
implemented this authority ever since. The only change made by the 
statutory requirement discussed above is to impose a 30-day deadline on 
the President to make such decisions in certain cases. As discussed in 
the IFR, this 30-day deadline applies to the Secretary's decisions, 
since the President delegated this decision-making authority to the 
Secretary. The deadline does not prolong the decision-making process 
since, prior to this statutory requirement, the Secretary was not under 
any deadline to make such decisions.

G. Non-Regulatory Comments

    HHS received several comments that do not pertain to the IFR. These 
included a comment to add a class of employees from the Hanford 
facility to the Cohort, a personal perspective on the history of the 
management of the U.S. nuclear weapons program, concerns about the 
involvement of the Office of Management and Budget (``OMB'') in the 
program, and a speculation that adding classes of employees to the 
Cohort would be cost-saving compared to the conduct of dose 
reconstructions.

[[Page 37458]]

    The Board recommended NIOSH provide petitioners with guidance in 
the form of a timeline for the petition process, to ensure petitioners 
understand the expected duration of the entire process and its 
elements, from the submission of a petition to the point at which final 
decisions on a petition become effective. NIOSH will provide each 
petitioner with such guidance, together with other introductory 
materials provided to petitioners upon the receipt by NIOSH of a 
petition.
    One commenter suggested all cancers be added to the list of 22 
``specified cancers'' covered for members of the Cohort. The list of 
specified cancers covered for members of the Cohort is established 
statutorily under EEOICPA and not governed by this rulemaking. EEOICPA 
states:
    The term ``specified cancer'' means any of the following:
    (A) A specified disease, as that term is defined in section 4(b)(2) 
of the Radiation Exposure Compensation Act (42 U.S.C. 2210 note).
    (B) Bone cancer.
    (C) Renal cancers.
    (D) Leukemia (other than chronic lymphocytic leukemia), if initial 
occupational exposure occurred before 21 years of age and onset 
occurred more than two years after initial occupational exposure. 42 
U.S.C. 7384l(17)

III. Regulatory Assessment Requirements

A. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
agency must determine whether a regulatory action is ``significant'' 
and therefore subject to review by OMB and the requirements of the 
Executive Order. Under section 3(f), the order defines a ``significant 
regulatory action'' as an action that is likely to result in a rule (1) 
having an annual effect on the economy of $100 million or more, or 
adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlements, grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the executive order.
    This rule is being treated as a ``significant regulatory action'' 
within the meaning of the executive order because it meets the 
criterion of Section 3(f)(4) in that it raises novel or legal policy 
issues arising out of the legal mandate established by EEOICPA. It 
amends current procedures by which the Secretary considers petitions to 
add classes of employees to the Cohort to comport with new statutory 
deadlines (see 42 U.S.C. 7384q(c)(2)(A) and 42 U.S.C. 
7384l(14)(C)(ii)). The revisions, however, neither affect the financial 
cost to the federal government of responding to these petitions nor the 
scientific and policy bases for making decisions on such petitions.
    The rule carefully explains the manner in which the procedures are 
consistent with the mandates of 42 U.S.C. 7384q and 7384l(14)(C)(ii) 
and implements the detailed requirements of these sections. The rule 
does not interfere with State, local, and tribal governments in the 
exercise of their governmental functions.
    The rule is not considered economically significant, as defined in 
Sec.  3(f)(1) of Executive Order 12866. As discussed above, it does not 
affect the financial cost to the federal government of responding to 
these petitions nor does it affect the scientific and policy bases for 
making decisions on such petitions. Furthermore, it has a subordinate 
role in the adjudication of claims under EEOICPA, serving as one 
element of an adjudication process administered by the Department of 
Labor (``DOL'') under 20 CFR parts 1 and 30. DOL has determined that 
its rule fulfills the requirements of Executive Order 12866 and 
provides estimates of the aggregate cost of benefits and administrative 
expenses of implementing EEOICPA under its rule (see 71 FR 78520, 
December 29, 2006). OMB has reviewed this rule for consistency with the 
President's priorities and the principles set forth in Executive Order 
12866.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (``RFA''), 5 U.S.C. 601 et. seq., 
requires each agency to consider the potential impact of its 
regulations on small entities, including small businesses, small 
governmental units, and small not-for-profit organizations. HHS 
certifies that this rule will not have a significant economic impact on 
a substantial number of small entities within the meaning of the RFA. 
The rule affects only HHS, DOL, the Department of Energy, and certain 
individuals covered by EEOICPA. Therefore, a regulatory flexibility 
analysis as provided for under RFA is not required.

C. What Are the Paperwork and Other Information Collection Requirements 
(Subject to the Paperwork Reduction Act) Imposed Under This Rule?

    The Paperwork Reduction Act (``PRA'') 44 U.S.C. 3501 et seq., 
requires an agency to invite public comment on and to obtain OMB 
approval of any regulation that requires ten or more people to report 
information to the agency or to keep certain records. The Special 
Exposure Cohort rule, 42 CFR part 83, which requires the collection of 
information from petitioners, is covered by the PRA and has received 
OMB clearance (OMB control 0920-0639). However, this 
rulemaking, which makes limited changes to 42 CFR part 83, does not 
contain any information collection requirements. Thus, HHS has 
determined that the PRA does not apply to this rulemaking.

D. Small Business Regulatory Enforcement Fairness Act

    As required by Congress under the Small Business Regulatory 
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), HHS will 
report to Congress promulgation of this rule prior to its taking 
effect. The report will state that HHS has concluded that this rule is 
not a ``major rule'' because it is not likely to result in an annual 
effect on the economy of $100 million or more. However, this rule has a 
subordinate role in the adjudication of claims under EEOICPA, serving 
as one element of an adjudication process administered by DOL under 20 
CFR parts 1 and 30. DOL has determined that its rule is a ``major 
rule'' because it will likely result in an annual effect on the economy 
of $100 million or more.

E. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 
et seq.) directs agencies to assess the effects of federal regulatory 
actions on State, local, and tribal governments and the private sector 
``other than to the extent that such regulations incorporate 
requirements specifically set forth in law.'' For purposes of the 
Unfunded Mandates Reform Act, this rule does not include any federal 
mandate that may result in increased annual expenditures in excess of 
$100 million by state, local or tribal governments in the aggregate, or 
by the private sector.

F. Executive Order 12988 (Civil Justice)

    This rule has been drafted and reviewed in accordance with 
Executive

[[Page 37459]]

Order 12988 on Civil Justice Reform and will not unduly burden the 
federal court system. HHS adverse decisions may be reviewed in United 
States District Courts pursuant to the APA. HHS has attempted to 
minimize that burden by providing petitioners an opportunity to seek 
administrative review of adverse decisions. HHS has provided a clear 
legal standard it will apply in considering petitions. This rule has 
been reviewed carefully to eliminate drafting errors and ambiguities.

G. Executive Order 13132 (Federalism)

    HHS has reviewed this rule in accordance with Executive Order 13132 
regarding federalism, and has determined that it does not have 
``federalism implications.'' The rule does not ``have substantial 
direct effects on the states, on the relationship between the national 
government and the states, or on the distribution of power and 
responsibilities among the various levels of government.''

H. Executive Order 13045 (Protection of Children From Environmental, 
Health Risks and Safety Risks)

    In accordance with Executive Order 13045, HHS has evaluated the 
environmental health and safety effects of this rule on children. HHS 
has determined that the rule would have no effect on children.

I. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)

    In accordance with Executive Order 13211, HHS has evaluated the 
effects of this rule on energy supply, distribution or use, and has 
determined that the rule will not have a significant adverse effect on 
them.

J. Effective Date

    The Secretary has determined, pursuant to 5 U.S.C. 553(d)(3), that 
there is good cause for this rule to be effective immediately to 
eliminate legal inconsistencies between new statutory requirements 
under 42 U.S.C. 7384l and 7384q and regulatory requirements under 42 
CFR part 83 and to make the implementation of the new statutory 
requirements feasible.

List of Subjects in 42 CFR Part 83

    Government employees, Occupational safety and health, Nuclear 
materials, Radiation protection, Radioactive materials, Workers' 
compensation.

Text of the Rule

0
For the reasons discussed in the preamble, the interim rule amending 42 
CFR part 83, published on December 22, 2005 (70 FR 75950), is confirmed 
as final with the folling changes:

PART 83--[AMENDED]

0
1. The authority citation for part 83 continues to read as follows:

    Authority: 42 U.S.C. 7384q; E.O. 13179, 65 FR 77487, 3 CFR, 2000 
Comp., p. 321.

Subpart B--Definitions


Sec.  83.5  [Amended]

0
2. Amend Sec.  83.5 by removing paragraph (k) and redesignating 
paragraphs (l) through (p) as paragraphs (k) through (o), respectively.

Subpart C--Procedures for Adding Classes of Employees to the Cohort

0
3. Amend Sec.  83.11 as follows:
0
A. By revising the section heading.
0
B. By replacing the term ``submission'' with the term ``petition'' in 
paragraphs (a) through (d) and (f).
0
C. By replacing the phrases ``7 calendar days'' and ``7 day period'' 
with ``30 calendar days'' and ``30-day period'', respectively, in 
paragraph (c).
0
D. By replacing ``8 calendar days'' with ``31 calendar days'' in 
paragraph (e).
0
E. By adding a new paragraph (g) to read as follows:


Sec.  83.11  What happens to petitions that do not satisfy all relevant 
requirements under Sec. Sec.  83.7 through 83.9?

* * * * *
    (g) A petitioner whose petition has been found not to satisfy the 
requirements for a petition under either paragraph (d) or (e) of this 
section may submit to NIOSH a new petition for the identical class of 
employees at any time thereafter on the basis of new information not 
provided to NIOSH in the original petition. In such a case, the 
petitioner is required to fully re-address all the requirements of 
Sec. Sec.  83.7-83.9 in the petition.

0
4. Amend Sec.  83.13 by revising paragraph (d)(4) and adding paragraph 
(e) to read as follows:


Sec.  83.13  How will NIOSH evaluate petitions, other than petitions by 
claimants covered under Sec.  83.14?

* * * * *
    (d)(4) A summary of the findings concerning the adequacy of 
existing records and information for reconstructing doses for 
individual members of the class under the methods of 42 CFR part 82 
specifying, for each class defined in the report, whether NIOSH finds 
that it is feasible to estimate the radiation doses of members of the 
class with sufficient accuracy, and a description of the evaluation 
methods and information upon which these findings are based; and
* * * * *
    (e) The NIOSH report under paragraph (d) of this section shall be 
completed within 180 calendar days of the receipt of the petition by 
NIOSH. The procedure for computing this time period is specified in 
Sec.  83.5(c). In addition, the computing of 180 calendar days shall 
not include any days during which the petitioner may be revising the 
petition to remedy deficiencies identified by NIOSH under Sec.  
83.11(a) or (b), nor shall it include any days during which the 
petitioner may request a review of a proposed finding under Sec.  
83.11(c) or during the conduct of such a review under Sec.  83.11(d).

    Dated: March 16, 2007.
Michael O. Leavitt,
Secretary, Department of Health and Human Services.

    Editorial Note: This document was received in the Office of the 
Federal Register on July 3, 2007.
[FR Doc. E7-13233 Filed 7-9-07; 8:45 am]
BILLING CODE 4163-18-P
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