        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 648
        [Docket No. 150309236-7563-01]
        RIN 0648-BE65
        Fisheries of the Northeastern United States; Mid-Atlantic Fishery Management Council; Omnibus Acceptable Biological Catch Framework Adjustment

          AGENCY:
          National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

          ACTION:
          Proposed rule; request for comments.

          SUMMARY:
          This action proposes regulations to implement an Omnibus Framework Adjustment to the Mid-Atlantic Fishery Management Council acceptable biological catch setting process. This proposed rule is necessary to provide the public with an opportunity to review and comment on the measures recommended by the Mid-Atlantic Council to the National Marine Fisheries Service for implementation. The intended effect of these measures would help bring stability to quotas while accounting for year-to-year changes in stock size projections, and allow the Mid-Atlantic Council's Fishery Management Plans to automatically incorporate the best available scientific information when calculating acceptable biological catches. This action also proposes to revise regulatory language to clarify the Mid-Atlantic Council's acceptable biological catch control rule assessment level designations.

          DATES:
          Comments must be received on or before August 18, 2017.

          ADDRESSES:
          You may submit comments, identified by NOAA-NMFS-2017-0056, by either of the following methods:
          • Electronic Submissions: Submit all electronic public comments via the Federal eRulemaking portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2017-0056, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.
          • Mail: Submit written comments to John Bullard, Regional Administrator, NMFS, Greater Atlantic Regional Fisheries Office, 55 Great Republic Drive, Gloucester, MA 01930.

            Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publically accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

          Copies of the Environmental Assessment and other supporting documents are available from Dr. Christopher M. Moore, Executive Director, Mid-Atlantic Fishery Management Council, Suite 201, 800 N. State Street, Dover, DE 19901. The draft Omnibus Framework Adjustment, as submitted by the Council, is also available via the internet at http://www.greateratlantic.fisheries.noaa.gov/.

          FOR FURTHER INFORMATION CONTACT:
          Reid Lichwell, Fishery Management Specialist, (978) 281-9112.

        SUPPLEMENTARY INFORMATION:
        Background
        The Mid-Atlantic Fishery Management Council (Council) is required to set annual catch limits (ACLs) that do not exceed the acceptable biological catch (ABC) recommendation of its Scientific and Statistical Committee (SSC) to prevent overfishing. ABCs represent an upper limit for the Council to use when setting catch and landing limits. The 2011 ACL Omnibus Amendment implementing rule (76 FR 60606; September 29, 2011), enacted the Council's risk policy that provides guidance to the SSC on how much overfishing risk the Council will accept when the SSC develops ABC recommendations. The policy also outlines risk tolerance for ensuring stocks under rebuilding plans achieve fishing mortality objectives.

        The Council's risk policy for setting ABCs states that for a typical species whose stock size is equal to or greater than a biomass target associated with maximum sustainable yield (BMSY), the acceptable probability of overfishing is 40 percent, i.e., if the fishery catches the ABC then there is a 60-percent probability of not overfishing. If a species is deemed to have an atypical life history, the Council requires at least a 35-percent probability of overfishing (i.e., a 65-percent chance of not overfishing), to create a larger buffer when biomass is at or above BMSY. The SSC determines whether a stock is typical or atypical each time an ABC is recommended. When an overfishing probability is available and considered reliable by the SSC, the applicable tolerance for overfishing risk, as informed by the Council's risk policy, would be selected to derive the ABC recommendation.

        For both typical and atypical species, the Council has specified that as stock size biomass or (B) falls below the target (BMSY), then the probability of overfishing decreases, until the probability of overfishing hits zero when the stock is at 10 percent of the target (BMSY). For a stock under a rebuilding plan, the probability of not exceeding the fishing mortality rate (F) within the specified timeframe must be at least 50 percent, unless this probability threshold is modified through a stock rebuilding plan.

        The fishery management plans (FMPs) managed by the Council all have provisions for setting specifications for multiple years (five years for dogfish and three years for all other species). Moving to multi-year specifications has not provided the anticipated stability to quotas over a multi-year period. This is because target fishing mortality rates are applied to stock size projections that tend to change from year-to-year, creating varying ABCs within multi-year quotas. The change to constant multi-year ABCs would help bring stability to quotas while accounting for year-to-year changes in stock size projections and prevent overfishing.
        Proposed Measures
        Overfishing Probability Averaging
        The proposed action would, when assessment fishing mortality reference points are accepted by the SSC, average the probability of overfishing (or achieving the target fishing mortality for rebuilding stocks) consistent with the existing risk policy requirements. The constant, multi-year ABCs that would result must continue to meet the Council's risk policy goals, with the probability of overfishing not to exceed 50 percent in any given year. For stocks in a rebuilding plan, the probability of achieving the rebuilding fishery mortality must meet the risk policy objectives when constant, multi-year ABCs are recommended by the SSC.
        Under the proposed measures, averaged ABCs could be set at a constant level for up to five years for spiny dogfish and up to three years for all other species managed by the Council. As an example, if the application of the risk policy would result in a 40-percent probability of overfishing in any given year of setting annual quotas, the average probability of overfishing resulting from constant multi-year ABCs cannot exceed 40 percent. For any 3-year period, an average ABC would result in slightly less chance of overfishing in some years and slightly more of a chance of overfishing in other years compared to non-averaged ABCs based on year-to-year projections, but could not, as outlined in the example, exceed 40 percent in any given year. This would result in a minimal difference of overfishing likelihood between the yearly ABCs versus a constant ABC over a 3-year period. As previously noted, the probability of overfishing could not exceed 50 percent in any given individual year of constant multi-year ABCs.
        The SSC may provide both a standard 3-year recommendation as well as a constant 3-year recommendation based on the average overfishing probability approach for the Council to consider. The SSC would continue to review fishery performance each year during multi-year specifications, regardless of which multi-year approach is used to determine ABCs. The multi-year averaging of ABCs would not apply to stocks that do not have a quantitative assessment to derive ABCs and could not be used for stocks with an assessment that cannot provide information on the risk of overfishing.
        ABC Control Rule Assessment Level Designations
        The proposed action would revise some of the regulatory language describing the Council's ABC control rule assessment level designations. These revisions were recommended by the Council to clarify the operation of the Council's ABC control rules, these revisions are merely clarifications and do not create any regulatory changes in practice.
        Notice of Approved Biological Status Criteria

        We are also providing notice of the administrative process the Council will use for incorporating the best scientific information available in the development of ABCs for the Atlantic Bluefish, Golden Tilefish, and Atlantic Mackerel, Squid, and Butterfish FMPs. The best available science requirements have dictated that accepted assessment information be utilized by the SSC in setting quotas under National Standard 2. The Council's SSC will utilize peer-reviewed biological reference points (overfishing level, biomass thresholds, etc.) and periodic updates to stock status determination criteria (i.e., biomass and fishing mortality reference points) to define ABCs, consistent with the Council's other FMPs and National Standards 1 and 2 of the Magnuson-Stevens Act. This change in Council operations would improve management efficiency by automatically incorporating new peer-reviewed status determination criteria instead of requiring a separate management action to adopt them within these three FMPs. Because best available science requirements have dictated that accepted assessment information be utilized by the SSC in recommending ABCs, this proposed measure would serve to clarify and simplify the administrative procedures for doing so. This same process has already been identified by the Council for their other FMPs.
        Classification
        Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has made a preliminary determination that this proposed rule is consistent with all the Mid-Atlantic Fishery Management Council's FMPs, provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.
        This proposed rule has been determined to be not significant for purposes of Executive Order 12866.
        The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The Small Business Administration defines a small business in the shellfish, finfish or other marine fishing sectors as a firm that is independently owned and operated with receipts of less than $11 million annually (see NMFS final rule revising the small business standard for commercial fishing, 80 FR 81194, December 29, 2015). The measures proposed in this action apply to the vessels that hold permits for Council-managed fisheries because all species have ABCs set by the SSC. According to permit data at the end of 2014, there were 4,712 vessels with at least one active Northeast Federal fishing permit, either commercial or party/charter (some vessels have both commercial and party/charter permits and most vessels have more than one permit).
        This proposed action would make it consistent with the Council's risk policy for the SSC to specify constant multi-year ABCs for all the Council's FMPs, provided the average of each year's probability of overfishing adhere to the appropriate overfishing probability goal. This change would help bring stability to fishing quotas while accounting for year-to-year changes in stock size projections and prevent overfishing. Given the inherent uncertainty involved in assessments, the differences are not expected to be meaningful from a biological perspective.
        In addition, the proposed action would add regulatory language clarifying the assessment level designations for the Council's ABC control rule. These changes to the regulations were recommended by the Council to merely clarify the ABC control rule and do not change its function or operation.

        This action also provides notice that the Atlantic Bluefish, Golden Tilefish, and Atlantic Mackerel, Squid, and Butterfish FMPs will automatically incorporate the best available scientific information in calculating ABCs. This means the SSC would utilize peer-reviewed biological reference points (overfishing level, biomass thresholds, etc.) and periodic updates to stock status determination criteria (i.e., biomass and fishing mortality reference points) to define ABCs, consistent with the Council's other FMPs and National Standards 1 and 2 of the Magnuson-Stevens Act. Since best available science requirements have dictated that accepted assessment information be utilized by the SSC in setting quotas, this measure would serve to clarify and simplify the administrative procedures for doing so.
        These measures are administrative and pertain to how the Council establishes catch limits. There is no reason to believe small entities will be negatively affected by the proposed action given the administrative nature of the changes. The resulting actions to set catch using these new procedures may have an indirect effect on small entities; however, catch setting will occur in separate subsequent actions that will include, as needed, analyses under the Regulatory Flexibility Act. As a result, an initial regulatory flexibility analysis is not required and none has been prepared.

          List of Subjects in 50 CFR Part 648
          Fisheries, Fishing, Recordkeeping and Reporting requirements.

          Dated: July 12, 2017.
          Samuel D. Rauch III,
          Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

        For the reasons set out in the preamble, NMFS proposes to amend 50 CFR 648 as follows:

          PART 648—FISHERIES OF THE NORTHEASTERN UNITED STATES

        1. The authority citation for part 648 continues to read as follows:

          Authority:
           16 U.S.C. 1801 et seq.

        2. Section 648.20 is revised to read as follows:

          § 648.20
           Mid-Atlantic Fishery Management Council Acceptable Biological Catch (ABC) control rules.
          The SSC shall review the following criteria, and any additional relevant information, to assign managed stocks to one of four types of control rules based on the species' assessments and its treatment of uncertainty when developing ABC recommendations. The SSC shall review the ABC control rule assignment for stocks each time an ABC is recommended. ABCs may be recommended for up to 3 years for all stocks, with the exception of 5 years for spiny dogfish. The SCC may specify constant, multi-year ABCs, derived from the average of ABCs (or average risk of overfishing) if the average probability of overfishing remains between zero and 40 percent, and does not exceed a 50-percent probability in any given year. The average ABCs may remain constant for up to 3 years for all stocks, with the exception of 5 years for spiny dogfish. The SSC may deviate from the control rule methods and recommend an ABC that differs from the result of the ABC control rule application; however, any such deviation must include the following: A description of why the deviation is warranted; description of the methods used to derive the alternative ABC; and an explanation of how the deviation is consistent with National Standard 2. The four types of ABC control rules are described below.
          (a) ABC control rule for a stock with an OFL probability distribution that is analytically-derived and accepted by the SSC.
          (1) The SSC determines that the assessment OFL and the assessment's treatment of uncertainty are acceptable, based on the following:
          (i) All important sources of scientific uncertainty are captured in the stock assessment model;
          (ii) The probability distribution of the OFL is calculated within the stock assessment and adequately describes the OFL uncertainty;
          (iii) The stock assessment model structure and treatment of the data prior to use in the model includes relevant details of the biology of the stock, fisheries that exploit the stock, and data collection methods;
          (iv) The stock assessment provides the following estimates: Fishing mortality rate (F) at MSY or an acceptable proxy maximum fishing mortality threshold (MFMT) to define OFL, biomass, biological reference points, stock status, OFL, and the respective uncertainties associated with each value; and
          (v) No substantial retrospective patterns exist in the stock assessment estimates of fishing mortality, biomass, and recruitment.
          (2) An ABC for stocks with an accepted OFL probability distribution that is analytically-derived will be determined by applying the acceptable probability of overfishing from the MAFMC's risk policy found in § 648.21(a) through (d) to the probability distribution of the OFL.
          (b) ABC control rule for a stock with an OFL probability distribution that is modified by the assessment team and accepted by the SSC.
          (1) The SSC determines the assessment OFL is acceptable and the SSC accepts the assessment team's modifications to the analytically-derived OFL probability distribution, based on the following:
          (i) Key features of the stock biology, the fisheries that exploit it, and/or the data collection methods for stock information are missing from, or poorly estimated in, the stock assessment;
          (ii) The stock assessment provides reference points (which may be proxies), stock status, and uncertainties associated with each; however, the uncertainty is not fully promulgated through the stock assessment model and/or some important sources of uncertainty may be lacking;
          (iii) The stock assessment provides estimates of the precision of biomass, fishing mortality, and reference points;
          (iv) The accuracy of the minimum fishing mortality threshold and projected future biomass is estimated in the stock assessment using ad hoc methods; and
          (v) The modified OFL probability distribution provided by the assessment team acceptably addresses the uncertainty of the assessment.
          (2) An ABC for stocks with an OFL probability distribution that is modified by the assessment team and accepted by the SSC will be determined by applying the acceptable probability of overfishing from the MAFMC's risk policy found in § 648.21(a) through (d) to the probability distribution of the OFL as modified by the assessment team.
          (c) ABC control rule for a stock with an OFL probability distribution that is modified by the SSC.
          (1) The SSC determines the assessment OFL is acceptable but the SSC derives the appropriate uncertainty for OFL based on meta-analysis and other considerations. This requires the SSC to determine that the stock assessment does not contain an estimated probability distribution of OFL or the OFL probability distribution in the stock assessment is judged by the SSC to not adequately reflect uncertainty in the OFL estimate.
          (2) An ABC for stocks with an OFL probability distribution that is modified by the SSC will be determined by either (i) applying the acceptable probability of overfishing from the MAFMC's risk policy found in § 648.21(a) through (d) to the SSC-adjusted OFL probability distribution. The SSC will use default assignments of uncertainty in the adjusted OFL probability distribution based on literature review and evaluation of control rule performance; or,

          (ii) If the SSC cannot develop an OFL probability distribution, a default control rule of 75 percent of the FMSY value will be applied to derive ABC.
          (d) ABC control rule for when an OFL cannot be specified.
          (1) The SSC determines that the OFL cannot be specified given the available information.
          (2) An ABC for stocks with an OFL that cannot be specified will be determined by using control rules based on biomass and catch history and application of the MAFMC's risk policy found in § 648.21(a) through (d).

      [FR Doc. 2017-15073 Filed 7-18-17; 8:45 am]
       BILLING CODE 3510-22-P


        DEPARTMENT OF DEFENSE
        GENERAL SERVICES ADMINISTRATION
        NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
        48 CFR Part 31
        [FAR Case 2009-006; Docket 2010-0084, Sequence 1]
        RIN 9000-AL39
        Federal Acquisition Regulation; FAR Case 2009-006, Labor Relations Costs

          AGENCY:
          Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).

          ACTION:
          Proposed rule.

          SUMMARY:
          The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) propose to amend the Federal Acquisition Regulation (FAR) to implement Executive Order 13494, Economy in Government Contracting, issued on January 30, 2009, and amended on October 30, 2009. This order treats as unallowable the costs of any activities undertaken to persuade employees, whether employees of the recipient of Federal disbursements or of any other entity, to exercise or not to exercise, or concerning the manner of exercising, the right to organize and bargain collectively through representatives of the employee's own choosing.

          DATES:
          Interested parties should submit written comments to the Regulatory Secretariat on or before June 14, 2010 to be considered in the formulation of a final rule.

          ADDRESSES:
          Submit comments identified by FAR case 2009-006 by any of the following methods:
          • Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by inputting “FAR Case 2009-006” under the heading “Enter Keyword or ID” and selecting “Search.” Select the link “Submit a Comment” that corresponds with “FAR Case 2009-006.” Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “FAR Case 2009-006” on your attached document.
          • Fax: 202-501-4067.
          • Mail: General Services Administration, Regulatory Secretariat (MVCB), 1800 F Street, NW., Room 4041, ATTN: Hada Flowers, Washington, DC 20405.

            Instructions: Please submit comments only and cite FAR case 2009-006, in all correspondence related to this case. All comments received will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided.

          FOR FURTHER INFORMATION CONTACT:
          Mr. Edward Chambers, Procurement Analyst, at (202) 501-3221, for clarification of content. For information pertaining to status or publication schedules, contact the Regulatory Secretariat at (202) 501-4755. Please cite FAR case 2009-006.

        SUPPLEMENTARY INFORMATION:
        A. Background

        Executive Order 13494, Economy in Government Contracting, dated January 30, 2009, was published in the Federal Register at 74 FR 6101 on February 4, 2009, as amended on October 30, 2009, was published in the Federal Register at 74 FR 57239 on November 5, 2009, provided that to promote economy and efficiency in Government contracting, certain costs that are not directly related to the contractor's provision of goods and services to the Government shall be unallowable for payment, thereby directly reducing Government expenditures. Thus, this order states that the costs of the activities of preparing and distributing materials; hiring or consulting legal counsel or consultants; holding meetings (including paying the salaries of the attendees at meetings held for this purpose); and planning or conducting activities by managers, supervisors, or union representatives during work hours, when they are undertaken to persuade employees to exercise or not to exercise, or concern the manner of exercising, rights to organize and bargain collectively are unallowable costs. This order is consistent with Government policy to remain impartial concerning any labor-management dispute involving Government contractors. This proposed rule will make the necessary changes within the FAR.
        This is a significant regulatory action and therefore was subject to review under Section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
        B. Regulatory Flexibility Act

        The Councils do not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because most contracts awarded to small entities use simplified acquisition procedures or are awarded on a competitive fixed-price basis, and do not require application of the cost principles contained in this rule. Further, the practical effect of the rule will be that contractors will no longer be reimbursed for costs incurred in promoting or opposing union organizing. It is substantially less likely that small businesses will incur costs of this nature. An Initial Regulatory Flexibility Analysis has, therefore, not been performed. The Councils invite comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
        The Councils will also consider comments from small entities concerning the existing regulations in FAR part 31 affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (FAR Case 2009-006) in all correspondence.
        C. Paperwork Reduction Act

        The Paperwork Reduction Act does not apply because the proposed changes to the FAR do not impose information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. chapter 35, et seq.

          List of Subjects in 48 CFR Part 31
          Government procurement.

          Dated: April 9, 2010.
          Edward Loeb,
          Acting Director, Acquisition Policy Division.

        Therefore, DoD, GSA, and NASA propose amending 48 CFR part 31 as set forth below:

          PART 31—CONTRACT COSTS PRINCIPLES AND PROCEDURES
          1. The authority citation for 48 CFR part 31 continues to read as follows:

            Authority:
            40 U.S.C. 121(c); 10 U.S.C. chapter 137; and 42 U.S.C. 2473(c).

          2. Revise section 31.205-21 to read as follows:

            31.205-21
            Labor relations costs.
            (a) Costs incurred in maintaining satisfactory relations between the contractor and its employees (other than those made unallowable in paragraph (b) of this section), including costs of shop stewards, labor management committees, employee publications, and other related activities, are allowable.
            (b) As required by Executive Order 13494, Economy in Government Contracting, costs of any activities undertaken to persuade employees, of any entity, to exercise or not to exercise, or concerning the manner of exercising, the right to organize and bargain collectively through representatives of the employees' own choosing are unallowable. Examples of unallowable costs in paragraph (b) of this section include, but are not limited to, the costs of—
            (1) Preparing and distributing materials;
            (2) Hiring or consulting legal counsel or consultants;
            (3) Meetings (including paying the salaries of the attendees at meetings held for this purpose); and
            (4) Planning or conducting activities by managers, supervisors, or union representatives during work hours.

      [FR Doc. 2010-8504 Filed 4-13-10; 8:45 am]
      BILLING CODE 6820-EP-P


        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        42 CFR Part 71
        [Docket No. CDC-2012-0002]
        RIN 0920-AA47
        Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver Samples

          AGENCY:
          Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

          ACTION:
          Notice of Proposed Rulemaking and request for comments.

          SUMMARY:

          Through this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is proposing to establish a user fee for filovirus testing of all nonhuman primates that die during the HHS/CDC-required 31-day quarantine period for any reason other than trauma. We propose to establish a filovirus testing service at HHS/CDC because testing is no longer being offered by the only private, commercial laboratory that previously performed these tests. This testing service will be funded through user fees. Elsewhere in this issue of the Federal Register, HHS/CDC is simultaneously publishing a companion direct final rule that proposes identical filovirus testing and user fee requirements in this Federal Register because it believes that these requirements are non-controversial and unlikely to generate significant adverse comment. If HHS/CDC does not receive any significant adverse comment on the direct final rule within the specified comment period, it will publish a notice in the Federal Register withdrawing this notice of proposed rulemaking and confirming the effective date of the direct final rule within 30 days after the end of the comment period on the direct final rule. If HHS/CDC receives any timely significant adverse comment, it will withdraw the direct final rule in part or in whole by publication of a notice in the Federal Register within 30 days after the comment period ends and proceed with notice and comment under this notice of proposed rulemaking. A significant adverse comment is one that explains: Why the direct final rule is inappropriate, including challenges to the rule's underlying premise or approach; or why the direct final rule will be ineffective or unacceptable without a change.

          DATES:
          Submit written or electronic comments by April 10, 2012.

          ADDRESSES:
          You may submit comments, identified by “RIN 0920-AA47”: By any of the following methods:
          • Internet: Access the Federal e-rulemaking portal at http://www.regulations.gov. Follow the instructions for submitting comments.
          • Mail: Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-03, Atlanta, Georgia 30333, ATTN: NHP NPRM.

            Instructions: All submissions received must include the agency name and docket number or Regulation Identifier Number (RIN) for this rulemaking. All comments will be posted without change to http://regulations.gov, including any personal information provided. For detailed instructions on submitting comments and additional information on the rulemaking process, see the “Public Participation” heading of the SUPPLEMENTARY INFORMATION section of this document.

            Docket: For access to the docket to read background documents or comments received, please go to http://www.regulations.gov. Comments will be available for public inspection Monday through Friday, except for legal holidays, from 9 a.m. until 5 p.m., Eastern Time, at 1600 Clifton Road NE., Atlanta, Georgia 30333. Please call ahead to 1-866-694-4867 and ask for a representative in the Division of Global Migration and Quarantine (DGMQ) to schedule your visit. To download an electronic version of the rule, access http://www.regulations.gov.

          FOR FURTHER INFORMATION CONTACT:
          For questions concerning this notice of proposed rulemaking: Ashley A. Marrone, JD, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop E-03, Atlanta, Georgia 30333; telephone 404 498-1600. For information concerning program operations: Dr. Robert Mullan, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop E-03, Atlanta, Georgia 30333; telephone 404 498-1600.

        SUPPLEMENTARY INFORMATION:
        This preamble is organized as follows:

          I. Public Participation
          II. Background
          III. Rationale for Proposal
          IV. User Fee
          V. Services and Activities Covered by This User Fees
          VI. Analysis of User Fee Charge (Cost to Government)
          VII. Payment Instructions
          VIII. Regulatory Analysis
          IX. References

        I. Public Participation
        Interested persons are invited to participate in this rulemaking by submitting written views, opinions, recommendations, and data. Comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you do not wish to be disclosed publicly. Comments are invited on any topic directly related to this proposed rule.
        II. Background

        Filoviruses belong to a family of viruses known to cause severe hemorrhagic fever in humans and nonhuman primates (NHPs). So far, only two members of this virus family have been identified: Ebola virus and Marburg virus. Five species of Ebola virus have been acknowledged: Zaire, Sudan, Reston, Ivory Coast, and Bundibugyo. Most strains of Ebola virus can be highly fatal in humans, and while the Reston strain is the only strain of filovirus that has not been reported to cause disease in humans, it can be fatal in monkeys. (http://www.cdc.gov/ncidod/dvrd/spb/mnpages/dispages/filoviruses.htm).

        Ebola hemorrhagic fever was first recognized in 1976, when two epidemics occurred in southern Sudan and in Zaire. Since that time, multiple outbreaks have occurred, mostly in Central Africa, and all have been associated with high (45-90%) case-fatality rates in humans (for an updated list see http://www.cdc.gov/ncidod/dvrd/spb/mnpages/dispages/ebola/ebolatable.htm). In these epidemics, transmission of the disease originated or occurred in a hospital (often by contaminated needles) and was followed by person-to-person transmission by individuals who were exposed to, or had close contact with blood or secretions from seriously ill patients.
        The ecology, natural history, and mode of transmission of Ebola virus in nature, and of the related Marburg virus, are becoming more clearly understood with the implication of bats as reservoirs. The incubation period for Ebola disease is 5-9 days (range: 2-15 days) but can be shorter with parenteral transmission. Disease onset is abrupt and characterized by severe malaise, headache, high fever, myalgia, joint pains, and sore throat. The progression is rapid and includes pharyngitis, conjunctivitis, diarrhea, abdominal pain, and occasionally facial edema and jaundice. Severe thrombocytopenia can occur, with hemorrhagic manifestations ranging from petechiae to frank bleeding. Death occurs primarily as a result of multi-organ failures. There is no specific therapy, and patient management is usually limited to supportive measures. The disease in nonhuman primates is very similar to that in humans, with a very high mortality.
        On January 19, 1990, in response to the identification of Ebola-Reston virus in NHPs imported from the Philippines, HHS/CDC published interim guidelines for handling NHPs during transit and also during quarantine (1). Importers of NHPs were informed by letter from the HHS/CDC Director on March 15, 1990, that they must comply with specific isolation and quarantine standards under 42 CFR part 71 for continued registration as an importer of NHPs (2).
        On March 23, 1990, HHS/CDC held a meeting at CDC headquarters in Atlanta, Georgia, at which the public could comment on new guidelines for the importation of NHPs and the potential impact of a temporary ban on the importation of cynomolgus monkeys into the United States (3). After considering information received at this public meeting, coupled with an April 4, 1990 confirmation of asymptomatic Ebola virus infection in four NHP caretakers and serologic findings suggesting that cynomolgus, African green, and rhesus monkeys posed a risk for human filovirus infection, HHS/CDC concluded that these three species were capable of being an animal host or vector of human disease (4).

        As a result, on April 20, 1990, HHS/CDC published a notice in the Federal Register requiring a special-permit for importing cynomolgus, African green, and rhesus monkeys (5). To be granted a special-permit, importers must submit a plan to HHS/CDC describing specific isolation, quarantine, and communicable disease control measures. The plan must detail the measures to be carried out at every step of the chain of custody, from embarkation at the country of origin, through delivery of the NHPs to the quarantine facility and the completion of the required quarantine period. Additional requirements include detailed testing procedures for all quarantined NHPs to rule out the possibility of filovirus infection. When importers demonstrate compliance with these special-permit requirements, HHS/CDC authorizes continued shipments under the same permit for a period of 180 days. Certain components of the special-permit requirement have changed slightly in response to surveillance findings and the development of improved laboratory tests. As indicated in the 1990 notice, importers were informed of these changes by letter from HHS/CDC (6). The current special-permit notice requires filovirus antigen-detection testing on liver specimens from any NHP that dies during quarantine for reasons other than trauma (7, 8). Antibody testing is also required on surviving NHPs that exhibit signs of possible filovirus infection before the cohort is released from quarantine (9).

        Since October 10, 1975, HHS/CDC has prohibited the importation of NHPs except for scientific, educational, or exhibition purposes. Over time, various measures (e.g., reports, letters, guidelines, notices), have been used to support implementation of these regulations. On January 5, 2011, HHS/CDC posted a Notice of Proposed Rulemaking (NPRM) to begin the process of revising these requirements. The NPRM was intended to solicit public comment and feedback on the issue of NHP importation to determine the need for further rulemaking. Please see the docket details for HHS-OS-2011-0002 on www.Regulations.gov, for more information. The public comment period ended on April 25, 2011. HHS/CDC is now working toward finalizing the proposed rule and is not seeking additional comment on the NPRM through this rulemaking.

        Laboratory testing of suspected NHPs and early detection of infected animals within the quarantine period prevents spread of disease among NHPs and caretakers (4). Since the implementation and strengthening of the 1990 special-permit requirements for importing nonhuman primates into the United States, the morbidity and mortality of imported animals has decreased from an estimated 20% to less than 1% (10). Since 1990, these laboratory tests have been conducted by a sole commercial laboratory. Recently, a number of circumstances have arisen such that this laboratory is no longer able to perform the testing for filovirus required on liver specimens from monkeys that die during the HHS/CDC-mandated quarantine. Further, HHS/CDC notes that the reagents required for this testing are not commercially available and production of the reagents requires a biosafety level 4 laboratory (BSL-4). A BSL-4 laboratory is also required during part of the testing procedure. To our knowledge, neither commercial entities nor Federal laboratories other than those at HHS/CDC are planning to offer this service. Because HHS/CDC has the required laboratory facility, access to the reagents, and experienced personnel, it has started performing this testing when required and in the absence of a viable alternative.
        III. Rationale for Proposal
        Through this NPRM, HHS/CDC is proposing to establish a user fee to reimburse HHS/CDC for the costs incurred performing the required filovirus testing and seeks public comment on this proposal. If promulgated as proposed, upon the effective date of the final rule, every NHP quarantine facility will be contacted by HHS/CDC's Division of Global Migration and Quarantine (DGMQ), and will be instructed how to transfer tissue specimens to HHS/CDC for testing. After receipt of the specimens, HHS/CDC will process the specimens in its BSL-4 laboratory and test the specimens by an antigen-detection enzyme-linked immunosorbant assay (ELISA) or other appropriate methodology. Each specimen will be held for six months. After six months, the specimen will be disposed of following established HHS/CDC protocol. Based on information supplied by the commercial laboratory, HHS/CDC estimates that between 100 and 150 specimens per year are expected to be received and tested. Results will be provided to the NHP importers. If a positive test result is found, HHS/CDC will ensure that the NHP cohort is not released from HHS/CDC required quarantine until the health status of the full cohort is determined. This testing protocol would be maintained until further notice.
        HHS/CDC has chosen to establish this testing service based on the unanticipated loss of the only commercially available antigen-detection ELISA filovirus testing facility. Currently, there are no commercially available assays for filovirus antigen detection in tissue samples and this testing cannot readily be performed in the private sector because the testing requires a BSL-4 laboratory and the reagents are not commercially available. Other factors which contribute to the necessity of the testing service include the limited availability of BSL-4 laboratories, the special expertise required to perform these tests, the lack of commercially-available reagents, the need and requirement for continued and ongoing filovirus testing to protect public health, the negative effect on science, education and exhibition if imports of NHPs are disrupted, and the lack of other testing alternatives.
        Nothing in this proposal is intended to prohibit a private sector facility from developing the capability and offering this same service in the future. The testing of non-human primate samples is necessary to prevent and control a potential outbreak of a filovirus infection in imported monkeys and to prevent the potential spread of filoviruses to humans.
        IV. User Fees
        Title V of the Independent Offices Appropriation Act of 1952 (31 U.S.C. 9701) (“IOAA”) provides general authority to Federal agencies to establish user fees through regulations. The IOAA sets parameters for any fee charged under its authority. Each charge shall be:

        (1) Fair; and
        (2) Based on—
        (A) The costs to the Government;
        (B) The value of the service or thing to the recipient;
        (C) Public-policy or interest served; and
        (D) Other relevant facts.

        OMB Circular A-25 (“the Circular”) establishes general policy for implementing user fees, including criteria for determining amounts and exceptions, and guidelines for implementation. According to the Circular, its provisions must be applied to any fees collected pursuant to the IOAA authority.

        The Circular states that “[a] user charge * * * will be assessed against each identifiable recipient for special benefits derived from Federal activities beyond those received by the general public.” The Circular gives three examples of when the special benefit is considered to accrue, including when a Government service: (a) Enables the beneficiary to obtain more immediate or substantial gains or values (which may or may not be measurable in monetary terms) than those that accrue to the general public (e.g., receiving a patent, insurance, or guarantee provision, or a license to carry on a specific activity or business or various kinds of public land use); or (b) provides business stability or contributes to public confidence in the business activity of the beneficiary (e.g., insuring deposits in commercial banks); or (c) is performed at the request of or for the convenience of the recipient, and is beyond the services regularly received by other members of the same industry or group or by the general public (e.g., receiving a passport, visa, airman's certificate, or a Customs inspection after regular duty hours).
        The Circular sets forth guidelines for determining the amount of user charges to assess. When the Government is acting in its sovereign capacity, user charges should be sufficient to cover the full cost to the Federal Government of providing the service, resource, or good.
        The Circular sets forth criteria for determining full cost. “Full cost includes all direct and indirect costs to any part of the Federal Government of providing a good, resource, or service.” Examples of these types of costs include, but are not limited to, direct and indirect personnel costs, including salaries and fringe benefits; physical overhead, consulting, and other indirect costs, including material and supply costs, utilities, insurance, travel, and rents; management and supervisory costs; and the costs of enforcement, collection, research, establishment of standards, and regulation. Full costs are determined based on the best available records of the agency.
        Agencies are responsible for the initiation and adoption of user charge schedules consistent with the guidance listed in the Circular. In doing so, agencies should identify the services and activities covered by the Circular; determine the extent of the special benefits provided; and apply the principles set forth in the Circular in determining full cost or market cost as appropriate.
        Finally, CDC has legal authority to retain collected user fees through its annual appropriations bill. In fiscal year 2012, this authority is provided through the Consolidated Appropriations Act of 2012, Public Law 112-74, 125 Stat. 1069, 1070 (2011).
        V. Services and Activities Covered by This User Fee
        HHS/CDC is establishing a user fee to recoup the costs associated with performing the required testing. The user fee will cover the costs of the test for filovirus for specimens submitted to HHS/CDC. The following is a list of services and activities that are covered by the user fee:
        • Providing information to the participants about the service, including instructions on submission of samples and payment;
        • Receiving payment and maintaining account, including distributing funds;
        • Tracking the shipment to ensure a safe arrival at HHS/CDC;
        • Providing reagents for and performing the antigen-detection test on submitted NHP liver samples in a BSL-4, high-containment facility;
        • Performing all provided services in accordance with industry standards, including quality assurance, handling and processing procedures, and hazardous medical waste guidelines; and

        • Ensuring that the importer receives the test results in a timely manner.

        VI. Analysis of User Fee Charge (Cost to the Government)

        HHS/CDC's analysis of costs to the Government is based on the current methodology (ELISA) used to test NHP liver samples. This cost determines the amount of the user fee. HHS/CDC notes that the use of a different methodology or changes in the availability of ELISA reagents will affect the amount of the user fee. HHS/CDC will impose the fee by schedule and will notify importers of changes to the user fee by notice in the Federal Register. Importers may also contact HHS/CDC at 404-498-1600 or check its Web site (http://www.cdc.gov/animalimportation/) for an up-to-date fee schedule.
        In its analysis of cost, HHS/CDC considered five components: (1) The cost of reagents and materials; (2) the cost of the BSL-4 laboratory in reagent production and during the assay; (3) the cost of irradiation of the sample; (4) personnel costs to perform the testing; and (5) administrative costs. The total cost to the Government is summarized in Table 1 followed by a description of each component; all monies reflected are in U.S. Dollars (USD).

          Table 1—Summary Calculations of User Fee Charge-per-Test

            Components
            Costs (USD)

            1. Use of reagents and other materials
            $100

            2. Use of BSL-4 lab facility
            112

            3. Irradiation (inactivation) of sample
            150

            4. Personnel costs to conduct testing
            145

            5. Administrative costs
            33

            ESTIMATED TOTAL
            540

            User Fee
            540

        The first component in the estimate is the cost of the reagent materials and other materials necessary to perform the test. Two reagents are used to prepare the specific antibodies needed in the test. These reagents are not commercially available and must be made in-house by HHS/CDC scientists. Since these reagents are not commercially available, there is no commercial or observable product pricing. HHS/CDC estimates the cost for these reagents to be $70.00. This amount includes the cost of production and validation of the reagents. Material costs include plastic plates, pipettes, and other reagents. These items are available commercially and their cost is estimated at $30.00. Thus, the total estimated cost for this component totals $100.00 per test. This cost can be a bit higher or lower depending on how many tests are run at the same time. If the test requests come in one at a time, then the cost might be above $100, if there is more than one request at a time, the cost might be a bit less than $100. The test calls for the same amount of reagents for one or 3 samples to test.
        The second component is the cost of the BSL-4 facility that is used to develop the reagents. We have estimated this cost on the charges made by University of Texas Medical Branch at Galveston (UTMB) of $28 per hour. The UTMB is the only BSL-4 facility in the United States that has developed commercial fees for the use of their labs. In the ELISA methodology, scientists need four hours in the BSL-4 laboratory to process the sample. The cost of this component is $112.00.
        The third component in the cost estimate is the cost to inactivate the sample by irradiation in an irradiator. For this component, we estimate the cost to use an irradiator at $30 per hour. This estimate is based on a five-year cost of $300,000 to HHS/CDC to run and maintain the irradiator. Irradiators are extremely expensive to maintain for a number of reasons. Only research facilities have irradiator equipment because of the need to inactivate high-hazard pathogens. Safety restrictions on irradiators are complex and time consuming; requiring frequent, professional safety inspections and complex annual training for all personnel that work with or near the irradiator. Finally, a high level of security must be maintained because the complexities of using irradiators and the specimens being irradiated require access to be controlled and monitored. Typically it takes five hours to inactivate a sample, at a total estimated irradiation cost of $150.

        The fourth component of the cost is the hourly wage and benefits of personnel who perform the laboratory tests. We assume that the scientist performing the test is a microbiologist with a masters' degree. Most of the personnel in this category are paid at a GS 11 level. For the purposes of this estimate, we have assumed a pay level of GS 11, Step 3. We set the basic wage at $25.70 per hour, and a benefit of 30% for a total hourly salary of $33.41 an hour (U.S. Office of Personnel Management 2010 General Schedule (GS) Locality Pay Tables for Atlanta; http://www.opm.gov/oca/11tables/indexgs.asp). In total, the tests take about 13 hours (four hours in the BSL-4; three hours of irradiation; and six hours running the test with interpretation). However, we assume that the person working on this test will be carrying on other duties simultaneously. Therefore, we assign one-third of the 13 hours of work time to the fourth part, or $145.00 ($434.33/3).

        The fifth and final component is the administrative costs related to test result collection and dissemination. The individual responsible for the activities under this component is typically in a supervisory position. The supervisor examines the assay to ensure that the positive and negative tests (quality controls) are accurate, and to ensure that the test was performed according to prescribed scientific standards. The supervisor puts the results on a response form and sends the results to the importer with a copy to CDC's Division of Global Migration and Quarantine (DGMQ). To calculate this cost, we used half an hour of the salary and benefits of a GS 14 level, Senior Health Scientist (601 series). The hourly rate of a GS14, level 3 is $50 (U.S. Office of Personnel Management 2010 General Schedule (GS) Locality Pay Tables for Atlanta; http://www.opm.gov/oca/10tables/indexgs.asp). We added 30% of the hourly rate for benefits to total $65.00. Thirty minutes of this individual's time is $33.00.

          Total cost: Adding these parts (Table 1) results in a grand total of $540. We note that our results can potentially vary from this figure for a couple of reasons. First, as mentioned already, commercial data are not available for some of the reagents so our calculation of their costs is an estimate and not based on observed market pricing. Second, the costs will vary depending on how many tests are conducted at one time. If multiple tests are run concurrently, then the costs would be a bit less. If only one test is conducted at one time, the costs will be relatively higher. Therefore, we set the cost of reimbursement per test at $540. We feel confident that this is a fair price to the importers because this amount is consistent with the sum charged by the commercial lab of $500.00 that previously performed these tests. We also note that our assumption of the effect of multiple tests is supported by past experience. HHS/CDC receives notification of about 100 to 150 requests performed per year. Although HHS/CDC cannot control the flow of tests and cannot forecast how many tests will be underway at any given point in time, HHS/CDC estimates that the total amount of fees charged will range from about $50,000 to $75,000 per year. The user fee charged for the testing will cover the costs of the test.

        HHS/CDC will impose the user fee by schedule. An up-to-date fee schedule is available from the Division of Global Migration & Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, Georgia 30333, 404-498-1600, or [insert url of Web site].
        VII. Payment Instructions
        HHS/CDC Importers should submit a check or money order in the amount of $540.00 (USD) made payable to Centers for Disease Control and Prevention for each test conducted at the time that specimens are submitted to the CDC for testing. The check(s) should be sent to Centers for Disease Control and Prevention, P.O. Box 15580, Atlanta, GA 30333.
        VIII. Regulatory Analyses
        A. Required Regulatory Analyses Under Executive Orders 12866 and 13563
        We have examined the impacts of the proposed rule under Executive Orders 12866 and 13563, which direct agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages, distributive impacts, and equity). Because the purpose of this rule is to provide a framework to determine a fair fee to charge for a service that has become unavailable in private, commercial markets within the United States, we have determined that the rule will not violate the intent of either of the Executive Orders because it will in no way prevent a private entity from entering the field and providing a similar, privatized service. If any private entity expresses an interest in providing this service, we will strongly encourage them to do so.
        B. Regulatory Flexibility Act
        We have examined the impacts of the proposed rule under the Regulatory Flexibility Act (5 U.S.C. 601-612). Unless we certify that the rule is not expected to have a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), requires agencies to analyze regulatory options that would minimize any significant economic impact of a rule on small entities. We certify that this rule will not have a significant economic impact on a substantial number of small entities within the meaning of the RFA.
        C. Small Business Regulatory Enforcement Fairness Act of 1996
        This regulatory action is not a major rule as defined by Sec. 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This proposed rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in cost or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.
        D. The Paperwork Reduction Act of 1995
        HHS/CDC has reviewed the information collection requirements of the proposed rule and has determined that the information collection requested in the proposed rule is already approved by the Office of Management and Budget (OMB) under OMB Control No. 0920-0263, expiration date 6/30/2014. The proposed rule does not contain any new data collection or record keeping requirements.
        E. National Environmental Policy Act (NEPA)
        Pursuant to 48 FR 9374 (list of HHS/CDC program actions that are categorically excluded from the NEPA environmental review process), HHS/CDC has determined that this action does not qualify for a categorical exclusion. In the absence of an applicable categorical exclusion, the Director, CDC, has determined that provisions amending 42 CFR 71.53 will not have a significant impact on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
        F. Civil Justice Reform (Executive Order 12988)
        This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under this proposed rule: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.
        G. Executive Order 13132 (Federalism)
        The Department 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. Plain Language Act of 2010
        Under Public Law 111-274 (October 13, 2010), executive Departments and Agencies are required to use plain language in documents that explain to the public how to comply with a requirement the Federal Government administers or enforces. HHS has attempted to use plain language in promulgating this rule consistent with the Federal Plain Writing Act guidelines.
        I. Conclusion
        In accordance with the provisions of Executive Order 12866, this proposed rule was not reviewed by the Office of Management and Budget.
        IX. References

          1. Centers for Disease Control and Prevention. Update: Ebola-Related Filovirus Infection in Nonhuman Primates and Interim Guidelines for Handling Nonhuman Primates during Transit and Quarantine. Morbidity and Mortality Weekly Report MMWR 1990; 39(2):22-24, 29-30.
          2. Roper, W.L. Dear interested party (letter). March 15, 1990. Available upon request: (404) 639-1600.
          3. 55 FR 10288, March 20, 1990, “Importation of Nonhuman Primates: Meeting.”
          4. Centers for Disease Control and Prevention. Update: Filovirus Infection in Animal Handlers. Morbidity and Mortality Weekly Report MMWR 1990; 39(13):221.
          5. 55 FR 15210, April 20, 1990, Requirement for a Special-permit to Import Cynomolgus, African Green, or rhesus Monkeys into the United States.
          6. Roper, W.L. Dear interested party (letter). October 10, 1991. Available upon request: (404) 639-1600.
          7. Ksiazek, Thomas G.; Rollin, Pierre E.; Jahrling, Peter B.; Johnson, Eugene; Dalgard, Dan W., and Peters, Clarence J. Enzyme immunosorbent assay for Ebola virus antigens in tissues of infected primates. Journal of Clinical Microbiology. 1992; (304):947-950.
          8. Ksiazek, Thomas G. Laboratory diagnosis of filovirus infections in nonhuman primates. Laboratory Animal. 1991; 20(7):34-46.
          9. Tipple, M.A. Dear interested party (letter). March 5, 1996. Available upon request: (404) 639-1600.
          10. Demarcus, T., Tipple, M., Ostrowski, S., U.S. Policy for Disease Control among Imported Nonhuman Primates, J Infect Dis. (1999) 179 (supplement 1): S281-S282.

          List of Subjects in 42 CFR Part 71
          Communicable diseases, Public health, Quarantine, Reporting and recordkeeping requirements, Testing, User fees.

        For the reasons set forth in the preamble, HHS proposes to amend 42 CFR part 71 as follows:

          PART 71—FOREIGN QUARANTINE
          1. The authority citation for part 71 continues to read as follows:

            Authority:
             Secs. 215 and 311 of the Public Health Service (PHS) Act, as amended (42 U.S.C. 216, 243); section 361-369, PHS Act, as amended (42 U.S.C. 264-272); 31 U.S.C. 9701.

            Subpart F—Importations

          2. In § 71.53, add paragraph (j) to read as follows:

            § 71.53
            Nonhuman primates.

            (j) Filovirus Testing Fee. (1) Non-human primate importers shall be charged a fee for filovirus testing of non-human primate liver samples submitted to the Centers for Disease Control and Prevention (CDC).
            (2) The fee shall be based on the cost of reagents and other materials necessary to perform the testing; the use of the laboratory testing facility; irradiation for inactivation of the sample; personnel costs associated with performance of the laboratory tests; and administrative costs for test planning, review of assay results, and dissemination of test results.

            (3) An up-to-date fee schedule is available from the Division of Global Migration & Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, Georgia 30333. Any changes in the fee schedule will be published in the Federal Register.
            (4) The fee must be paid in U.S. dollars at the time that the importer submits the specimens to HHS/CDC for testing.

            Dated: January 19, 2012.
            Kathleen Sebelius,
            Secretary.

      [FR Doc. 2012-2841 Filed 2-9-12; 8:45 am]
      BILLING CODE 4163-18-P


        FEDERAL COMMUNICATIONS COMMISSION
        47 CFR Part 54
        [WC Docket Nos. 10-90 and 14-259; Report 3025]
        Petition for Reconsideration of Action in a Rulemaking Proceeding

          AGENCY:
          Federal Communications Commission.

          ACTION:
          Petition for reconsideration.

          SUMMARY:
          A Petition for Reconsideration (Petition) has been filed in the Commission's Rulemaking proceeding by Harold Mordkofsky, on behalf of Halstad Telephone Company.

          DATES:
          Oppositions to the Petition must be filed on or before August 24, 2015. Replies to an opposition must be filed on or before September 1, 2015.

          ADDRESSES:
          Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.

          FOR FURTHER INFORMATION CONTACT:

          Alexander Minard, Telecommunications Access Policy Division, Wireline Competition Bureau, (202) 418-7400, email: Alexander.Minard@fcc.gov, TTY (202) 418-0484.

        SUPPLEMENTARY INFORMATION:
        This is a summary of Commission's document, Report No. 3025, released July 20, 2015. The full text of Report No. 3025 is available for viewing and copying in Room CY-B402, 445 12th Street SW., Washington, DC or may be accessed online via the Commission's Electronic Comment Filing System at http://apps.fcc.gov/ecfs/. The Commission will not send a copy of this document pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A), because this document does not have an impact on any rules of particular applicability.

          Subjects: Connect America Fund; Rural Broadband Experiments, released by the Commission on June 15, 2015, in WC Docket Nos. 10-90 and 14-259, and published pursuant to 47 CFR 1.429(e). See also § 1.4(b)(1) of the Commission's rules.

          Number of Petitions Filed: 1.

          Federal Communications Commission.
          Marlene H. Dortch,
          Secretary.

      [FR Doc. 2015-19374 Filed 8-6-15; 8:45 am]
      BILLING CODE 6712-01-P