Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Proposed Rules 7109

ADDRESSES: You may submit comments, DEPARTMENT OF HEALTH AND ADDRESSES: You may submit comments, identified by RIN 1250–AA02, by any of HUMAN SERVICES identified by ‘‘RIN 0920–AA47’’: By any the following methods: of the following methods: 42 CFR Part 71 • Federal eRulemaking Portal: • Internet: Access the Federal e- www.regulations.gov. Follow the [Docket No. CDC–2012–0002] rulemaking portal at http:// instructions for submitting comments. RIN 0920–AA47 www.regulations.gov. Follow the instructions for submitting comments. • Fax: (202) 693–1304 (for comments of six pages or less). Establishment of User Fees for • Mail: Division of Global Migration Filovirus Testing of Nonhuman Primate and Quarantine, Centers for Disease • Mail: Debra A. Carr, Director, Liver Samples Control and Prevention, 1600 Clifton Division of Policy, Planning, and Road NE., MS–03, , Georgia AGENCY: Centers for Disease Control and Program Development, Office of Federal 30333, ATTN: NHP NPRM. Contract Compliance Programs, Room Prevention (CDC), Department of Health C–3325, 200 Constitution Avenue NW., and Human Services (HHS). Instructions: All submissions received Washington, DC 20210. ACTION: Notice of Proposed Rulemaking must include the agency name and and request for comments. docket number or Regulation Identifier FOR FURTHER INFORMATION CONTACT: Number (RIN) for this rulemaking. All Debra A. Carr, Director, Division of SUMMARY: Through this Notice of comments will be posted without Policy, Planning and Program Proposed Rulemaking (NPRM), the change to http://regulations.gov, Development, Office of Federal Contract Centers for Disease Control and including any personal information Compliance Programs, 200 Constitution Prevention (CDC), located within the provided. For detailed instructions on Avenue NW., Room C–3325, Department of Health and Human submitting comments and additional Washington, DC 20210. Telephone: Services (HHS) is proposing to establish information on the rulemaking process, (202) 693–0103 (voice) or (202) 693– a user fee for filovirus testing of all see the ‘‘Public Participation’’ heading 1337 (TTY). nonhuman primates that die during the of the SUPPLEMENTARY INFORMATION HHS/CDC-required 31-day quarantine section of this document. SUPPLEMENTARY INFORMATION: On period for any reason other than trauma. Docket: For access to the docket to December 9, 2011, OFCCP published a We propose to establish a filovirus read background documents or proposed rule entitled, ‘‘Affirmative testing service at HHS/CDC because comments received, please go to Action and Nondiscrimination testing is no longer being offered by the http://www.regulations.gov. Comments Obligations of Contractors and only private, commercial laboratory that will be available for public inspection Subcontractors Regarding Individuals previously performed these tests. This Monday through Friday, except for legal with Disabilities’’ (76 FR 77056). OFCCP testing service will be funded through holidays, from 9 a.m. until 5 p.m., was to receive comments on this NPRM user fees. Elsewhere in this issue of the Eastern Time, at 1600 Clifton Road NE., Federal Register, HHS/CDC is on or before February 7, 2012. Atlanta, Georgia 30333. Please call simultaneously publishing a companion Various organizations and entities ahead to 1–866–694–4867 and ask for a direct final rule that proposes identical submitted requests to extend the representative in the Division of Global filovirus testing and user fee comment period by an additional 90 Migration and Quarantine (DGMQ) to requirements in this Federal Register days or more. We considered these schedule your visit. To download an because it believes that these requests and determined that it is electronic version of the rule, access requirements are non-controversial and appropriate to provide an additional 14- http://www.regulations.gov. unlikely to generate significant adverse day period for comment on the comment. If HHS/CDC does not receive FOR FURTHER INFORMATION CONTACT: For proposed regulation. We are, therefore, any significant adverse comment on the questions concerning this notice of extending the comment period until, direct final rule within the specified proposed rulemaking: Ashley A. Tuesday, February 21, 2012. comment period, it will publish a notice Marrone, JD, Centers for Disease Control Extension of Comment Period: OFCCP in the Federal Register withdrawing and Prevention, 1600 Clifton Road NE., determined that the public could use this notice of proposed rulemaking and Mailstop E–03, Atlanta, Georgia 30333; additional time to review the potential confirming the effective date of the telephone 404 498–1600. For impact of the proposed requirements. direct final rule within 30 days after the information concerning program Therefore, to allow the public sufficient end of the comment period on the direct operations: Dr. Robert Mullan, Centers time to review and comment on the final rule. If HHS/CDC receives any for Disease Control and Prevention, NPRM, OFCCP is extending the timely significant adverse comment, it 1600 Clifton Road NE., Mailstop E–03, comment period until February 21, will withdraw the direct final rule in Atlanta, Georgia 30333; telephone 404 2012. part or in whole by publication of a 498–1600. notice in the Federal Register within 30 SUPPLEMENTARY INFORMATION: This Signed at Washington, DC, this 6th day of days after the comment period ends and preamble is organized as follows: February, 2012. proceed with notice and comment Patricia A. Shiu, under this notice of proposed I. Public Participation Director, Office of Federal Contract rulemaking. A significant adverse II. Background Compliance Programs. comment is one that explains: Why the III. Rationale for Proposal IV. User Fee [FR Doc. 2012–3106 Filed 2–7–12; 11:15 am] direct final rule is inappropriate, V. Services and Activities Covered by This BILLING CODE 4510–45–P including challenges to the rule’s underlying premise or approach; or why User Fees VI. Analysis of User Fee Charge (Cost to the direct final rule will be ineffective Government) or unacceptable without a change. VII. Payment Instructions DATES: Submit written or electronic VIII. Regulatory Analysis comments by April 10, 2012. IX. References

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I. Public Participation occur, with hemorrhagic manifestations development of improved laboratory Interested persons are invited to ranging from petechiae to frank tests. As indicated in the 1990 notice, participate in this rulemaking by bleeding. Death occurs primarily as a importers were informed of these submitting written views, opinions, result of multi-organ failures. There is changes by letter from HHS/CDC (6). recommendations, and data. Comments no specific therapy, and patient The current special-permit notice received, including attachments and management is usually limited to requires filovirus antigen-detection other supporting materials, are part of supportive measures. The disease in testing on liver specimens from any the public record and subject to public nonhuman primates is very similar to NHP that dies during quarantine for that in humans, with a very high reasons other than trauma (7, 8). disclosure. Do not include any mortality. Antibody testing is also required on information in your comment or On January 19, 1990, in response to surviving NHPs that exhibit signs of supporting materials that you do not the identification of - possible filovirus infection before the wish to be disclosed publicly. in NHPs imported from the Philippines, cohort is released from quarantine (9). Comments are invited on any topic HHS/CDC published interim guidelines Since October 10, 1975, HHS/CDC has directly related to this proposed rule. for handling NHPs during transit and prohibited the importation of NHPs II. Background also during quarantine (1). Importers of except for scientific, educational, or NHPs were informed by letter from the exhibition purposes. Over time, various Filoviruses belong to a family of HHS/CDC Director on March 15, 1990, measures (e.g., reports, letters, viruses known to cause severe that they must comply with specific guidelines, notices), have been used to hemorrhagic fever in humans and isolation and quarantine standards support implementation of these nonhuman primates (NHPs). So far, only under 42 CFR part 71 for continued regulations. On January 5, 2011, HHS/ two members of this virus family have registration as an importer of NHPs (2). CDC posted a Notice of Proposed been identified: Ebola virus and On March 23, 1990, HHS/CDC held a Rulemaking (NPRM) to begin the virus. Five species of Ebola meeting at CDC headquarters in Atlanta, process of revising these requirements. virus have been acknowledged: Zaire, Georgia, at which the public could The NPRM was intended to solicit Sudan, Reston, Ivory Coast, and comment on new guidelines for the public comment and feedback on the Bundibugyo. Most strains of Ebola virus importation of NHPs and the potential issue of NHP importation to determine can be highly fatal in humans, and impact of a temporary ban on the the need for further rulemaking. Please while the Reston strain is the only strain importation of cynomolgus monkeys see the docket details for HHS–OS– of filovirus that has not been reported to into the United States (3). After 2011–0002 on www.Regulations.gov, for cause disease in humans, it can be fatal considering information received at this more information. The public comment in monkeys. (http://www.cdc.gov/ public meeting, coupled with an April period ended on April 25, 2011. HHS/ ncidod/dvrd/spb/mnpages/dispages/ 4, 1990 confirmation of asymptomatic CDC is now working toward finalizing filoviruses.htm). Ebola virus infection in four NHP the proposed rule and is not seeking Ebola hemorrhagic fever was first caretakers and serologic findings additional comment on the NPRM recognized in 1976, when two suggesting that cynomolgus, African through this rulemaking. epidemics occurred in southern Sudan green, and rhesus monkeys posed a risk Laboratory testing of suspected NHPs and in Zaire. Since that time, multiple for human filovirus infection, HHS/CDC and early detection of infected animals outbreaks have occurred, mostly in concluded that these three species were within the quarantine period prevents Central , and all have been capable of being an animal host or spread of disease among NHPs and associated with high (45–90%) case- vector of human disease (4). caretakers (4). Since the implementation fatality rates in humans (for an updated As a result, on April 20, 1990, HHS/ and strengthening of the 1990 special- list see http://www.cdc.gov/ncidod/ CDC published a notice in the Federal permit requirements for importing dvrd/spb/mnpages/dispages/ebola/ Register requiring a special-permit for nonhuman primates into the United ebolatable.htm). In these epidemics, importing cynomolgus, African green, States, the morbidity and mortality of transmission of the disease originated or and rhesus monkeys (5). To be granted imported animals has decreased from an occurred in a hospital (often by a special-permit, importers must submit estimated 20% to less than 1% (10). contaminated needles) and was a plan to HHS/CDC describing specific Since 1990, these laboratory tests have followed by person-to-person isolation, quarantine, and been conducted by a sole commercial transmission by individuals who were communicable disease control laboratory. Recently, a number of exposed to, or had close contact with measures. The plan must detail the circumstances have arisen such that this blood or secretions from seriously ill measures to be carried out at every step laboratory is no longer able to perform patients. of the chain of custody, from the testing for filovirus required on liver The ecology, natural history, and embarkation at the country of origin, specimens from monkeys that die mode of transmission of Ebola virus in through delivery of the NHPs to the during the HHS/CDC-mandated nature, and of the related , quarantine facility and the completion quarantine. Further, HHS/CDC notes are becoming more clearly understood of the required quarantine period. that the reagents required for this testing with the implication of bats as Additional requirements include are not commercially available and reservoirs. The incubation period for detailed testing procedures for all production of the reagents requires a Ebola disease is 5–9 days (range: 2–15 quarantined NHPs to rule out the biosafety level 4 laboratory (BSL–4). A days) but can be shorter with parenteral possibility of filovirus infection. When BSL–4 laboratory is also required during transmission. Disease onset is abrupt importers demonstrate compliance with part of the testing procedure. To our and characterized by severe malaise, these special-permit requirements, knowledge, neither commercial entities headache, high fever, myalgia, joint HHS/CDC authorizes continued nor Federal laboratories other than those pains, and sore throat. The progression shipments under the same permit for a at HHS/CDC are planning to offer this is rapid and includes pharyngitis, period of 180 days. Certain components service. Because HHS/CDC has the conjunctivitis, diarrhea, abdominal of the special-permit requirement have required laboratory facility, access to the pain, and occasionally facial edema and changed slightly in response to reagents, and experienced personnel, it jaundice. Severe thrombocytopenia can surveillance findings and the has started performing this testing when

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required and in the absence of a viable testing of non-human primate samples The Circular sets forth criteria for alternative. is necessary to prevent and control a determining full cost. ‘‘Full cost potential outbreak of a filovirus includes all direct and indirect costs to III. Rationale for Proposal infection in imported monkeys and to any part of the Federal Government of Through this NPRM, HHS/CDC is prevent the potential spread of providing a good, resource, or service.’’ proposing to establish a user fee to filoviruses to humans. Examples of these types of costs reimburse HHS/CDC for the costs IV. User Fees include, but are not limited to, direct incurred performing the required and indirect personnel costs, including filovirus testing and seeks public Title V of the Independent Offices salaries and fringe benefits; physical comment on this proposal. If Appropriation Act of 1952 (31 U.S.C. overhead, consulting, and other indirect promulgated as proposed, upon the 9701) (‘‘IOAA’’) provides general costs, including material and supply effective date of the final rule, every authority to Federal agencies to costs, utilities, insurance, travel, and NHP quarantine facility will be establish user fees through regulations. rents; management and supervisory contacted by HHS/CDC’s Division of The IOAA sets parameters for any fee costs; and the costs of enforcement, Global Migration and Quarantine charged under its authority. Each charge collection, research, establishment of (DGMQ), and will be instructed how to shall be: standards, and regulation. Full costs are transfer tissue specimens to HHS/CDC (1) Fair; and determined based on the best available for testing. After receipt of the (2) Based on— records of the agency. specimens, HHS/CDC will process the (A) The costs to the Government; Agencies are responsible for the specimens in its BSL–4 laboratory and (B) The value of the service or thing initiation and adoption of user charge test the specimens by an antigen- to the recipient; schedules consistent with the guidance detection enzyme-linked (C) Public-policy or interest served; listed in the Circular. In doing so, immunosorbant assay (ELISA) or other and agencies should identify the services appropriate methodology. Each (D) Other relevant facts. and activities covered by the Circular; specimen will be held for six months. OMB Circular A–25 (‘‘the Circular’’) After six months, the specimen will be establishes general policy for determine the extent of the special disposed of following established HHS/ implementing user fees, including benefits provided; and apply the CDC protocol. Based on information criteria for determining amounts and principles set forth in the Circular in supplied by the commercial laboratory, exceptions, and guidelines for determining full cost or market cost as HHS/CDC estimates that between 100 implementation. According to the appropriate. and 150 specimens per year are Circular, its provisions must be applied Finally, CDC has legal authority to expected to be received and tested. to any fees collected pursuant to the retain collected user fees through its Results will be provided to the NHP IOAA authority. annual appropriations bill. In fiscal year importers. If a positive test result is The Circular states that ‘‘[a] user 2012, this authority is provided through found, HHS/CDC will ensure that the charge * * * will be assessed against the Consolidated Appropriations Act of NHP cohort is not released from HHS/ each identifiable recipient for special 2012, Public Law 112–74, 125 Stat. CDC required quarantine until the benefits derived from Federal activities 1069, 1070 (2011). beyond those received by the general health status of the full cohort is V. Services and Activities Covered by public.’’ The Circular gives three determined. This testing protocol would This User Fee be maintained until further notice. examples of when the special benefit is HHS/CDC has chosen to establish this considered to accrue, including when a HHS/CDC is establishing a user fee to testing service based on the Government service: (a) Enables the recoup the costs associated with unanticipated loss of the only beneficiary to obtain more immediate or performing the required testing. The commercially available antigen- substantial gains or values (which may user fee will cover the costs of the test detection ELISA filovirus testing or may not be measurable in monetary for filovirus for specimens submitted to facility. Currently, there are no terms) than those that accrue to the HHS/CDC. The following is a list of commercially available assays for general public (e.g., receiving a patent, services and activities that are covered filovirus antigen detection in tissue insurance, or guarantee provision, or a by the user fee: samples and this testing cannot readily license to carry on a specific activity or • Providing information to the be performed in the private sector business or various kinds of public land participants about the service, including because the testing requires a BSL–4 use); or (b) provides business stability or instructions on submission of samples laboratory and the reagents are not contributes to public confidence in the and payment; commercially available. Other factors business activity of the beneficiary (e.g., • Receiving payment and maintaining which contribute to the necessity of the insuring deposits in commercial banks); account, including distributing funds; testing service include the limited or (c) is performed at the request of or • Tracking the shipment to ensure a availability of BSL–4 laboratories, the for the convenience of the recipient, and safe arrival at HHS/CDC; special expertise required to perform is beyond the services regularly received • these tests, the lack of commercially- by other members of the same industry Providing reagents for and available reagents, the need and or group or by the general public (e.g., performing the antigen-detection test on requirement for continued and ongoing receiving a passport, visa, airman’s submitted NHP liver samples in a BSL– filovirus testing to protect public health, certificate, or a Customs inspection after 4, high-containment facility; • the negative effect on science, education regular duty hours). Performing all provided services in and exhibition if imports of NHPs are The Circular sets forth guidelines for accordance with industry standards, disrupted, and the lack of other testing determining the amount of user charges including quality assurance, handling alternatives. to assess. When the Government is and processing procedures, and Nothing in this proposal is intended acting in its sovereign capacity, user hazardous medical waste guidelines; to prohibit a private sector facility from charges should be sufficient to cover the and developing the capability and offering full cost to the Federal Government of • Ensuring that the importer receives this same service in the future. The providing the service, resource, or good. the test results in a timely manner.

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VI. Analysis of User Fee Charge (Cost lower depending on how many tests are be carrying on other duties to the Government) run at the same time. If the test requests simultaneously. Therefore, we assign HHS/CDC’s analysis of costs to the come in one at a time, then the cost one-third of the 13 hours of work time Government is based on the current might be above $100, if there is more to the fourth part, or $145.00 ($434.33/ methodology (ELISA) used to test NHP than one request at a time, the cost 3). liver samples. This cost determines the might be a bit less than $100. The test The fifth and final component is the amount of the user fee. HHS/CDC notes calls for the same amount of reagents for administrative costs related to test result that the use of a different methodology one or 3 samples to test. collection and dissemination. The or changes in the availability of ELISA The second component is the cost of individual responsible for the activities reagents will affect the amount of the the BSL–4 facility that is used to under this component is typically in a user fee. HHS/CDC will impose the fee develop the reagents. We have estimated supervisory position. The supervisor by schedule and will notify importers of this cost on the charges made by examines the assay to ensure that the changes to the user fee by notice in the University of Texas Medical Branch at positive and negative tests (quality Federal Register. Importers may also Galveston (UTMB) of $28 per hour. The controls) are accurate, and to ensure that contact HHS/CDC at 404–498–1600 or UTMB is the only BSL–4 facility in the the test was performed according to check its Web site (http://www.cdc.gov/ United States that has developed prescribed scientific standards. The animalimportation/) for an up-to-date commercial fees for the use of their labs. supervisor puts the results on a fee schedule. In the ELISA methodology, scientists response form and sends the results to In its analysis of cost, HHS/CDC need four hours in the BSL–4 laboratory the importer with a copy to CDC’s considered five components: (1) The to process the sample. The cost of this Division of Global Migration and cost of reagents and materials; (2) the component is $112.00. Quarantine (DGMQ). To calculate this cost of the BSL–4 laboratory in reagent The third component in the cost cost, we used half an hour of the salary production and during the assay; (3) the estimate is the cost to inactivate the and benefits of a GS 14 level, Senior cost of irradiation of the sample; (4) sample by irradiation in an irradiator. Health Scientist (601 series). The hourly personnel costs to perform the testing; For this component, we estimate the rate of a GS14, level 3 is $50 (U.S. Office cost to use an irradiator at $30 per hour. and (5) administrative costs. The total of Personnel Management 2010 General This estimate is based on a five-year cost to the Government is summarized Schedule (GS) Locality Pay Tables for cost of $300,000 to HHS/CDC to run and in Table 1 followed by a description of Atlanta; http://www.opm.gov/oca/ maintain the irradiator. Irradiators are each component; all monies reflected 10tables/indexgs.asp). We added 30% of extremely expensive to maintain for a are in U.S. Dollars (USD). the hourly rate for benefits to total number of reasons. Only research $65.00. Thirty minutes of this facilities have irradiator equipment TABLE 1—SUMMARY CALCULATIONS individual’s time is $33.00. because of the need to inactivate high- Total cost: Adding these parts (Table OF USER FEE CHARGE-PER-TEST hazard pathogens. Safety restrictions on 1) results in a grand total of $540. We irradiators are complex and time note that our results can potentially vary Costs Components (USD) consuming; requiring frequent, from this figure for a couple of reasons. professional safety inspections and First, as mentioned already, commercial 1. Use of reagents and other mate- complex annual training for all data are not available for some of the rials ...... $100 personnel that work with or near the reagents so our calculation of their costs 2. Use of BSL–4 lab facility ...... 112 irradiator. Finally, a high level of is an estimate and not based on 3. Irradiation (inactivation) of sample 150 security must be maintained because the observed market pricing. Second, the 4. Personnel costs to conduct test- complexities of using irradiators and the costs will vary depending on how many ing ...... 145 5. Administrative costs ...... 33 specimens being irradiated require tests are conducted at one time. If access to be controlled and monitored. multiple tests are run concurrently, then ESTIMATED TOTAL ...... 540 Typically it takes five hours to the costs would be a bit less. If only one inactivate a sample, at a total estimated test is conducted at one time, the costs User Fee ...... 540 irradiation cost of $150. will be relatively higher. Therefore, we The fourth component of the cost is set the cost of reimbursement per test at The first component in the estimate is the hourly wage and benefits of $540. We feel confident that this is a fair the cost of the reagent materials and personnel who perform the laboratory price to the importers because this other materials necessary to perform the tests. We assume that the scientist amount is consistent with the sum test. Two reagents are used to prepare performing the test is a microbiologist charged by the commercial lab of the specific antibodies needed in the with a masters’ degree. Most of the $500.00 that previously performed these test. These reagents are not personnel in this category are paid at a tests. We also note that our assumption commercially available and must be GS 11 level. For the purposes of this of the effect of multiple tests is made in-house by HHS/CDC scientists. estimate, we have assumed a pay level supported by past experience. HHS/CDC Since these reagents are not of GS 11, Step 3. We set the basic wage receives notification of about 100 to 150 commercially available, there is no at $25.70 per hour, and a benefit of 30% requests performed per year. Although commercial or observable product for a total hourly salary of $33.41 an HHS/CDC cannot control the flow of pricing. HHS/CDC estimates the cost for hour (U.S. Office of Personnel tests and cannot forecast how many these reagents to be $70.00. This amount Management 2010 General Schedule tests will be underway at any given includes the cost of production and (GS) Locality Pay Tables for Atlanta; point in time, HHS/CDC estimates that validation of the reagents. Material costs http://www.opm.gov/oca/11tables/ the total amount of fees charged will include plastic plates, pipettes, and indexgs.asp). In total, the tests take range from about $50,000 to $75,000 per other reagents. These items are available about 13 hours (four hours in the BSL– year. The user fee charged for the testing commercially and their cost is estimated 4; three hours of irradiation; and six will cover the costs of the test. at $30.00. Thus, the total estimated cost hours running the test with HHS/CDC will impose the user fee by for this component totals $100.00 per interpretation). However, we assume schedule. An up-to-date fee schedule is test. This cost can be a bit higher or that the person working on this test will available from the Division of Global

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Migration & Quarantine, Centers for C. Small Business Regulatory on the States, on the relationship Disease Control and Prevention, 1600 Enforcement Fairness Act of 1996 between the national government and Clifton Road, Atlanta, Georgia 30333, This regulatory action is not a major the States, or on the distribution of 404–498–1600, or [insert url of Web rule as defined by Sec. 804 of the Small power and responsibilities among the site]. Business Regulatory Enforcement various levels of government.’’ Fairness Act of 1996. This proposed rule VII. Payment Instructions H. Plain Language Act of 2010 will not result in an annual effect on the HHS/CDC Importers should submit a economy of $100,000,000 or more; a Under Public Law 111–274 (October check or money order in the amount of major increase in cost or prices; or 13, 2010), executive Departments and $540.00 (USD) made payable to Centers significant adverse effects on Agencies are required to use plain for Disease Control and Prevention for competition, employment, investment, language in documents that explain to each test conducted at the time that productivity, innovation, or on the the public how to comply with a ability of United States-based specimens are submitted to the CDC for requirement the Federal Government companies to compete with foreign- administers or enforces. HHS has testing. The check(s) should be sent to based companies in domestic and attempted to use plain language in Centers for Disease Control and export markets. promulgating this rule consistent with Prevention, P.O. Box 15580, Atlanta, GA the Federal Plain Writing Act 30333. D. The Paperwork Reduction Act of 1995 guidelines. VIII. Regulatory Analyses HHS/CDC has reviewed the I. Conclusion A. Required Regulatory Analyses Under information collection requirements of In accordance with the provisions of Executive Orders 12866 and 13563 the proposed rule and has determined that the information collection Executive Order 12866, this proposed We have examined the impacts of the requested in the proposed rule is rule was not reviewed by the Office of proposed rule under Executive Orders already approved by the Office of Management and Budget. 12866 and 13563, which direct agencies Management and Budget (OMB) under IX. References to assess all costs and benefits of OMB Control No. 0920–0263, expiration available regulatory alternatives and, date 6/30/2014. The proposed rule does 1. Centers for Disease Control and when regulation is necessary, to select not contain any new data collection or Prevention. Update: Ebola-Related Filovirus Infection in Nonhuman regulatory approaches that maximize record keeping requirements. Primates and Interim Guidelines for net benefits (including potential E. National Environmental Policy Act Handling Nonhuman Primates during economic, environmental, public health (NEPA) Transit and Quarantine. Morbidity and and safety, and other advantages, Mortality Weekly Report MMWR 1990; distributive impacts, and equity). Pursuant to 48 FR 9374 (list of HHS/ 39(2):22–24, 29–30. Because the purpose of this rule is to CDC program actions that are 2. Roper, W.L. Dear interested party (letter). provide a framework to determine a fair categorically excluded from the NEPA March 15, 1990. Available upon request: environmental review process), HHS/ fee to charge for a service that has (404) 639–1600. CDC has determined that this action become unavailable in private, 3. 55 FR 10288, March 20, 1990, does not qualify for a categorical ‘‘Importation of Nonhuman Primates: commercial markets within the United exclusion. In the absence of an Meeting.’’ States, we have determined that the rule applicable categorical exclusion, the 4. Centers for Disease Control and will not violate the intent of either of Director, CDC, has determined that Prevention. Update: Filovirus Infection the Executive Orders because it will in provisions amending 42 CFR 71.53 will in Animal Handlers. Morbidity and no way prevent a private entity from not have a significant impact on the Mortality Weekly Report MMWR 1990; entering the field and providing a human environment. Therefore, neither 39(13):221. similar, privatized service. If any private an environmental assessment nor an 5. 55 FR 15210, April 20, 1990, Requirement for a Special-permit to Import entity expresses an interest in providing environmental impact statement is this service, we will strongly encourage Cynomolgus, African Green, or rhesus required. Monkeys into the United States. them to do so. F. Civil Justice Reform (Executive Order 6. Roper, W.L. Dear interested party (letter). B. Regulatory Flexibility Act 12988) October 10, 1991. Available upon request: (404) 639–1600. We have examined the impacts of the This proposed rule has been reviewed 7. Ksiazek, Thomas G.; Rollin, Pierre E.; proposed rule under the Regulatory under Executive Order 12988, Civil Jahrling, Peter B.; Johnson, Eugene; Flexibility Act (5 U.S.C. 601–612). Justice Reform. Under this proposed Dalgard, Dan W., and Peters, Clarence J. Unless we certify that the rule is not rule: (1) All State and local laws and Enzyme immunosorbent assay for Ebola virus antigens in tissues of infected expected to have a significant economic regulations that are inconsistent with this rule will be preempted; (2) no primates. Journal of Clinical impact on a substantial number of small retroactive effect will be given to this Microbiology. 1992; (304):947–950. entities, the Regulatory Flexibility Act, rule; and (3) administrative proceedings 8. Ksiazek, Thomas G. Laboratory diagnosis as amended by the Small Business will not be required before parties may of filovirus infections in nonhuman Regulatory Enforcement Fairness Act file suit in court challenging this rule. primates. Laboratory Animal. 1991; (SBREFA), requires agencies to analyze 20(7):34–46. regulatory options that would minimize G. Executive Order 13132 (Federalism) 9. Tipple, M.A. Dear interested party (letter). March 5, 1996. Available upon request: any significant economic impact of a The Department has reviewed this rule on small entities. We certify that (404) 639–1600. rule in accordance with Executive Order 10. Demarcus, T., Tipple, M., Ostrowski, S., this rule will not have a significant 13132 regarding federalism, and has U.S. Policy for Disease Control among economic impact on a substantial determined that it does not have Imported Nonhuman Primates, J Infect number of small entities within the ‘‘federalism implications.’’ The rule Dis. (1999) 179 (supplement 1): S281– meaning of the RFA. does not ‘‘have substantial direct effects S282.

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List of Subjects in 42 CFR Part 71 Subpart F—Importations administrative costs for test planning, review of assay results, and Communicable diseases, Public 2. In § 71.53, add paragraph (j) to read dissemination of test results. health, Quarantine, Reporting and as follows: (3) An up-to-date fee schedule is recordkeeping requirements, Testing, § 71.53 Nonhuman primates. available from the Division of Global User fees. Migration & Quarantine, Centers for * * * * * For the reasons set forth in the Disease Control and Prevention, 1600 (j) Filovirus Testing Fee. (1) Non- Clifton Road, Atlanta, Georgia 30333. preamble, HHS proposes to amend 42 human primate importers shall be CFR part 71 as follows: Any changes in the fee schedule will be charged a fee for filovirus testing of non- published in the Federal Register. human primate liver samples submitted PART 71—FOREIGN QUARANTINE (4) The fee must be paid in U.S. to the Centers for Disease Control and dollars at the time that the importer Prevention (CDC). 1. The authority citation for part 71 submits the specimens to HHS/CDC for (2) The fee shall be based on the cost testing. continues to read as follows: of reagents and other materials Authority: Secs. 215 and 311 of the Public necessary to perform the testing; the use Dated: January 19, 2012. Health Service (PHS) Act, as amended (42 of the laboratory testing facility; Kathleen Sebelius, U.S.C. 216, 243); section 361–369, PHS Act, irradiation for inactivation of the Secretary. as amended (42 U.S.C. 264–272); 31 U.S.C. sample; personnel costs associated with [FR Doc. 2012–2841 Filed 2–9–12; 8:45 am] 9701. performance of the laboratory tests; and BILLING CODE 4163–18–P

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