        FEDERAL COMMUNICATIONS COMMISSION
        47 CFR Part 76
        [MB Docket No. 07-42; FCC 07-208]
        Leased Commercial Access

          AGENCY:
          Federal Communications Commission.

          ACTION:
          Proposed rule.

          SUMMARY:
          In this document, the Commission seeks comment on the application of the Commission's revised leased access rate methodology and maximum allowable leased access rate to programmers that predominantly transmit sales presentations or program length commercials.

          DATES:
          Comments for this proceeding are due on or before March 31, 2008; reply comments are due on or before April 14, 2008.

          ADDRESSES:
          You may submit comments, identified by MB Docket No. 07-42, by any of the following methods:
          • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
          • Federal Communications Commission's Web site: http://www.fcc.gov/cgb/ecfs/. Follow the instructions for submitting comments.
          • People with Disabilities: Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by e-mail: FCC504@fcc.gov or phone: 202-418-0530 or TTY: 202-418-0432.

          For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document.

          FOR FURTHER INFORMATION CONTACT:

          For additional information on this proceeding, contact Steven Broeckaert, Steven.Broeckaert@fcc.gov; or Katie Costello, Katie.Costello@fcc.gov; of the Media Bureau, Policy Division, 202-418-2120.

        SUPPLEMENTARY INFORMATION:
        This is a summary of the Commission's Notice of Proposed Rulemaking (NPRM), contained in MB Docket No. 07-42, FCC 07-208, adopted on November 27, 2007, and released on February 1, 2008. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Center, Federal Communications Commission, 445 12th Street, SW., CY-A257, Washington, DC 20554. This document will also be available via ECFS (http://www.fcc.gov/cgb/ecfs/). (Documents will be available electronically in ASCII, Word 97, and/or Adobe Acrobat.) The complete text may be purchased from the Commission's copy contractor, 445 12th Street, SW., Room CY-B402, Washington, DC 20554. To request this document in accessible formats (computer diskettes, large print, audio recording, and Braille), send an e-mail to fcc504@fcc.gov or call the Commission's Consumer and Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).
        Initial Paperwork Reduction Act of 1995 Analysis
        This document has been analyzed with respect to the Paperwork Reduction Act of 1995 (“PRA”), Public Law No. 104-13, 109 Stat 163 (1995) (codified in Chapter 35 of title 44 U.S.C.), and contains no proposed new or modified information collection requirements. In addition, therefore, it does not contain any new or modified “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002 (“SBPRA”), Public Law No. 107-198, 116 Stat 729 (2002) (codified in Chapter 35 of title 44 U.S.C.); see 44 U.S.C. 3506(c)(4).
        Summary of Notice of Proposed Rulemaking
        I. Application of Leased Access Rules to Certain Programmers

        1. The commercial leased access requirements are set forth in Section 612 of the Communications Act of 1934, as amended. The statute and corresponding leased access rules require a cable operator to set aside channel capacity for commercial use by unaffiliated video programmers. The purposes of Section 612 are “to promote competition in the delivery of diverse sources of video programming and to assure that the widest possible diversity of information sources are made available to the public from cable systems in a manner consistent with growth and development of cable systems.” In Report and Order, FCC 07-208, the Commission modified the leased access rate methodology but did not apply the changes to rates charged to programmers that predominantly transmit sales presentations or program length commercials. These direct sales programmers often “pay” for carriage—either directly or through some form of revenue sharing with the cable operator. In this Notice of Proposed Rulemaking (NPRM), the Commission seeks comment on whether the new methodology should be applied to the rates charged to programmers that predominantly transmit sales presentations or program length commercials.
        2. In the Report and Order, the Commission modified the method for determining the leased access rate for full-time carriage on a tier and harmonized the rate methodology for carriage on tiers with more than 50% subscriber penetration and carriage on tiers with lower levels of penetration by calculating the leased access rate based upon the characteristics of the tier on which the leased access programming will be placed. Cable operators will calculate a leased access rate for each cable system on a tier-by-tier basis which will adequately compensate the operator for the net revenue that is lost when a leased access programmer displaces an existing program channel on the cable system. The Report and Order adopted a methodology to determine the “marginal implicit fee” rather than the “average implicit fee” in calculating leased access rates. The “average implicit fee” is calculated based on the average value of all of the channels in a tier instead of the value of the channels most likely to be replaced. The revised methodology eliminates this excess recovery. In addition, the Report and Order set a maximum allowable leased access rate of $0.10 per subscriber per month to ensure that leased access remains a viable outlet for programmers.
        3. The Commission concluded not to apply the new rate methodology to programmers that predominantly transmit sales presentations or program length commercials. These programmers often “pay” for carriage—either directly or through some form of revenue sharing with the cable operator. Previously to the Report and Order, the Commission set the leased access rate for a la carte programmers at the “highest implicit fee” partly out of a concern that lower rates would simply lead these programmers to migrate to leased access if it were less expensive than what they are currently “paying” for carriage. Such a migration would not add to the diversity of voices and would potentially financially harm the cable system. The a la carte rate remains unchanged. Similarly, the Commission does not wish to set the leased access rates at a point at which programmers that predominantly transmit sales presentations or program length commercials simply migrate to leased access because it is less expensive than their current commercial arrangements. The Commission seeks on whether leased access is affordable at current rates to programmers that predominantly transmit sales presentations or program length commercials and whether reduced rates would simply cause migration of existing services to leased access.
        4. The Commission is concerned about setting the leased access rates at a point at which programmers that predominantly transmit sales presentations or program length commercials simply migrate to leased access because it is less expensive than their current commercial arrangements. Accordingly, the Commission seeks comment regarding the use of leased access by programmers that predominantly transmit sales presentations and program length commercials. Specifically, is leased access affordable to these programmers at current rates? Will applying the modified rate formula discussed previously in this Report and Order cause migration of existing services to leased access? What would be the effect of such a migration? Is a separate category for direct sales programmers appropriate?
        II. Procedural Matters
        A. Ex Parte Rules
        5. Permit-But-Disclose. The NPRM in this proceeding will be treated as “permit-but-disclose” subject to the “permit-but-disclose” requirements under § 1.1206(b) of the Commission's rules. Ex parte presentations are permissible if disclosed in accordance with Commission rules, except during the Sunshine Agenda period when presentations, ex parte or otherwise, are generally prohibited. Persons making oral ex parte presentations are reminded that a memorandum summarizing a presentation must contain a summary of the substance of the presentation and not merely a listing of the subjects discussed. More than a one- or two-sentence description of the views and arguments presented is generally required. Additional rules pertaining to oral and written presentations are set forth in § 1.1206(b).
        B. Filing Requirements
        6. Information. For additional information on this proceeding, contact Katie Costello, Katie.Costello@fcc.gov of the Media Bureau, Policy Division, (202) 418-2120.
        7. Comment Information. Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using: (1) The Commission's Electronic Comment Filing System (ECFS), (2) the Federal Government's eRulemaking Portal, or (3) by filing paper copies. See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121, May 1, 1998.
        • Electronic Filers: Comments may be filed electronically using the Internet by accessing the ECFS: http://www.fcc.gov/cgb/ecfs/ or the Federal eRulemaking Portal: http://www.regulations.gov. Filers should follow the instructions provided on the website for submitting comments.

        • For ECFS filers, if multiple docket or rulemaking numbers appear in the caption of this proceeding, filers must transmit one electronic copy of the comments for each docket or rulemaking number referenced in the caption. In completing the transmittal screen, filers should include their full name, U.S. Postal Service mailing address, and the applicable docket or rulemaking number. Parties may also submit an electronic comment by Internet e-mail. To get filing instructions, filers should send an e-mail to ecfs@fcc.gov, and include the following words in the body of the message, “get form.” A sample form and directions will be sent in response.
        • Paper Filers: Parties who choose to file by paper must file an original and four copies of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.

        Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail (although we continue to experience delays in receiving U.S. Postal Service mail). All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

        • The Commission's contractor will receive hand-delivered or messenger-delivered paper filings for the Commission's Secretary at 236 Massachusetts Avenue, NE., Suite 110, Washington, DC 20002. The filing hours at this location are 8 a.m. to 7 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes must be disposed of before entering the building.
        • Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.
        • U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street, SW., Washington, DC 20554.
        • People With Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an e-mail to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).
        8. Availability of Documents. Comments, reply comments, and ex parte submissions will be available for public inspection during regular business hours in the FCC Reference Center, Federal Communications Commission, 445 12th Street, SW., CY-A257, Washington, DC 20554. Persons with disabilities who need assistance in the FCC Reference Center may contact Bill Cline at (202) 418-0267 (voice), (202) 418-7365 (TTY), or bill.cline@fcc.gov. These documents also will be available from the Commission's Electronic Comment Filing System. Documents are available electronically in ASCII, Word 97, and Adobe Acrobat. Copies of filings in this proceeding may be obtained from Best Copy and Printing, Inc., Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554; they can also be reached by telephone, at (202) 488-5300 or (800) 378-3160; by e-mail at fcc@bcpiweb.com; or via their Web site at http://www.bcpiweb.com. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an e-mail to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0531 (voice), (202) 418-7365 (TTY).
        C. Initial Paperwork Reduction Act of 1995 Analysis

        9. The FNPRM has been analyzed with respect to the Paperwork Reduction Act of 1995 (“PRA”), Public Law No. 104-13, 109 Stat 163 (1995) (codified in Chapter 35 of title 44 U.S.C.) and contains no proposed new or modified information collection requirements. In addition, therefore, it does not contain any new or modified “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002 (“SBPRA”), Public Law No. 107-198, 116 Stat 729 (2002) (codified in Chapter 35 of title 44 U.S.C.); see 44 U.S.C. 3506(c)(4).
        III. Initial Regulatory Flexibility Analysis
        10. The Regulatory Flexibility Act of 1980, as amended (“RFA”), requires that a regulatory flexibility analysis be prepared for notice and comment rule making proceedings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). As required by the RFA, the Commission has prepared an Initial Regulatory Flexibility Analysis (“IRFA”) of the possible significant economic impact on a substantial number of small entities of the proposals addressed in the FNPRM Initial Regulatory Flexibility Analysis.

        11. As required by the Regulatory Flexibility Act of 1980, as amended (the “RFA”) the Commission has prepared this Initial Regulatory Flexibility Analysis (“IRFA”) of the possible significant economic impact on small entities by the policies and rules proposed in the Further Notice of Proposed Rulemaking (“FNPRM”). Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments provided on the first page of the document. The Commission will send a copy of the FNPRM, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (“SBA”). In addition, the FNPRM and IRFA (or summaries thereof) will be published in the Federal Register.
        A. Need for, and Objectives of, the Proposed Rules
        12. Overview. The commercial leased access requirements set forth in Section 612 of the Communications Act of 1934 require a cable operator to set aside channel capacity for commercial use by video programmers unaffiliated with the cable operator. The purposes of Section 612 are “to promote competition in the delivery of diverse sources of video programming and to assure that the widest possible diversity of information sources are made available to the public from cable systems in a manner consistent with growth and development of cable systems.”
        13. In the Report and Order in MB Docket No. 07-42, the Commission modified its formula used to calculate commercial leased access rates, which will result in making leased access channels a more viable outlet for leased access programming. The Order also provides that the maximum leased access rate will not exceed $0.10 per subscriber per month for any cable system. The Order, however, did not apply the modified rate formula or the maximum allowable leased access rate to programmers that predominantly transmit sales presentations or program length commercials. These direct sales programmers often “pay” for carriage—either directly or through some form of revenue sharing with the cable operator.
        14. In the FNPRM, the Commission notes its concern about setting the leased access rates at a point at which programmers that predominantly transmit sales presentations or program length commercials simply migrate to leased access because it is less expensive than their current commercial arrangements. Accordingly, the FNPRM considers whether leased access at current rates is affordable to programmers that predominantly transmit sales presentations and program length commercials. The FNPRM considers whether applying the modified leased access rate formula to programmers that predominantly transmit sales presentations or program length commercials will cause migration of these services to leased access. If these services do migrate to leased access, the FNPRM considers the effect of such a migration. The FNPRM also considers whether a separate category for direct sales programmers is appropriate.

        15. In the FNPRM, the Commission seeks comment on the foregoing issues. In particular, the FNPRM invites comment on issues that may impact small entities, including cable operators and leased access programmers.

        B. Legal Basis
        16. The authority for the action proposed in the rulemaking is contained in Section 4(i), 303, and 612 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 303, and 532.
        C. Description and Estimate of the Number of Small Entities to Which the Proposed Rules Will Apply
        17. The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (“SBA”).
        18. Wired Telecommunications Carriers. The 2007 North American Industry Classification System (“NAICS”) defines “Wired Telecommunications Carriers” (2007 NAISC code 517110) to include the following three classifications which were listed separately in the 2002 NAICS: Wired Telecommunications Carriers (2002 NAICS code 517110), Cable and Other Program Distribution (2002 NAISC code 517510), and Internet Service Providers (2002 NAISC code 518111). The 2007 NAISC defines this category as follows: “This industry comprises establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired telecommunications networks. Transmission facilities may be based on a single technology or a combination of technologies. Establishments in this industry use the wired telecommunications network facilities that they operate to provide a variety of services, such as wired telephony services, including VoIP services; wired (cable) audio and video programming distribution; and wired broadband Internet services. By exception, establishments providing satellite television distribution services using facilities and infrastructure that they operate are included in this industry.” The SBA has developed a small business size standard for Wired Telecommunications Carriers, which is all firms having 1,500 employees or less. According to Census Bureau data for 2002, there were a total of 27,148 firms in the Wired Telecommunications Carriers category (2002 NAISC code 517110) that operated for the entire year; 6,021 firms in the Cable and Other Program Distribution category (2002 NAISC code 517510) that operated for the entire year; and 3,408 firms in the Internet Service Providers category (2002 NAISC code 518111) that operated for the entire year. Of these totals, 25,374 of 27,148 firms in the Wired Telecommunications Carriers category (2002 NAISC code 517110) had less than 100 employees; 5,496 of 6,021 firms in the Cable and Other Program Distribution category (2002 NAISC code 517510) had less than 100 employees; and 3,303 of the 3,408 firms in the Internet Service Providers category (2002 NAISC code 518111) had less than 100 employees. Thus, under this size standard, the majority of firms can be considered small.
        19. Cable and Other Program Distribution. The 2002 NAICS defines this category as follows: “This industry comprises establishments primarily engaged as third-party distribution systems for broadcast programming. The establishments of this industry deliver visual, aural, or textual programming received from cable networks, local television stations, or radio networks to consumers via cable or direct-to-home satellite systems on a subscription or fee basis. These establishments do not generally originate programming material.” This category includes, among others, cable operators, direct broadcast satellite (“DBS”) services, home satellite dish (“HSD”) services, satellite master antenna television (“SMATV”) systems, and open video systems (“OVS”). The SBA has developed a small business size standard for Cable and Other Program Distribution, which is all such firms having $13.5 million or less in annual receipts. According to Census Bureau data for 2002, there were a total of 1,191 firms in this category that operated for the entire year. Of this total, 1,087 firms had annual receipts of under $10 million, and 43 firms had receipts of $10 million or more but less than $25 million. Thus, under this size standard, the majority of firms can be considered small.
        20. Cable System Operators (Rate Regulation Standard). The Commission has also developed its own small business size standards for the purpose of cable rate regulation. Under the Commission's rules, a “small cable company” is one serving 400,000 or fewer subscribers nationwide. As of 2006, 7,916 cable operators qualify as small cable companies under this standard. In addition, under the Commission's rules, a “small system” is a cable system serving 15,000 or fewer subscribers. Industry data indicate that 6,139 systems have under 10,000 subscribers, and an additional 379 systems have 10,000-19,999 subscribers. Thus, under this standard, most cable systems are small.
        21. Cable System Operators (Telecom Act Standard). The Communications Act of 1934, as amended, also contains a size standard for small cable system operators, which is “a cable operator that, directly or through an affiliate, serves in the aggregate fewer than 1 percent of all subscribers in the United States and is not affiliated with any entity or entities whose gross annual revenues in the aggregate exceed $250,000,000.” There are approximately 65.4 million cable subscribers in the United States today. Accordingly, an operator serving fewer than 654,000 subscribers shall be deemed a small operator, if its annual revenues, when combined with the total annual revenues of all its affiliates, do not exceed $250 million in the aggregate. Based on available data, we find that the number of cable operators serving 654,000 subscribers or less totals approximately 7,916. We note that the Commission neither requests nor collects information on whether cable system operators are affiliated with entities whose gross annual revenues exceed $250 million. Although it seems certain that some of these cable system operators are affiliated with entities whose gross annual revenues exceed $250,000,000, we are unable at this time to estimate with greater precision the number of cable system operators that would qualify as small cable operators under the definition in the Communications Act.
        22. Direct Broadcast Satellite (“DBS”) Service. DBS service is a nationally distributed subscription service that delivers video and audio programming via satellite to a small parabolic “dish” antenna at the subscriber's location. Because DBS provides subscription services, DBS falls within the SBA-recognized definition of Cable and Other Program Distribution. This definition provides that a small entity is one with $13.5 million or less in annual receipts. Currently, three operators provide DBS service, which requires a great investment of capital for operation: DIRECTV, EchoStar (marketed as the DISH Network), and Dominion Video Satellite, Inc. (“Dominion”) (marketed as Sky Angel). All three currently offer subscription services. Two of these three DBS operators, DIRECTV and EchoStar Communications Corporation (“EchoStar”), report annual revenues that are in excess of the threshold for a small business. The third DBS operator, Dominion's Sky Angel service, serves fewer than one million subscribers and provides 20 family and religion-oriented channels. Dominion does not report its annual revenues. The Commission does not know of any source which provides this information and, thus, we have no way of confirming whether Dominion qualifies as a small business. Because DBS service requires significant capital, we believe it is unlikely that a small entity as defined by the SBA would have the financial wherewithal to become a DBS licensee. Nevertheless, given the absence of specific data on this point, we recognize the possibility that there are entrants in this field that may not yet have generated $13.5 million in annual receipts, and therefore may be categorized as a small business, if independently owned and operated.
        23. Private Cable Operators (PCOs) also known as Satellite Master Antenna Television (SMATV) Systems. PCOs, also known as SMATV systems or private communication operators, are video distribution facilities that use closed transmission paths without using any public right-of-way. PCOs acquire video programming and distribute it via terrestrial wiring in urban and suburban multiple dwelling units such as apartments and condominiums, and commercial multiple tenant units such as hotels and office buildings. The SBA definition of small entities for Cable and Other Program Distribution Services includes PCOs and, thus, small entities are defined as all such companies generating $13.5 million or less in annual receipts. Currently, there are approximately 150 members in the Independent Multi-Family Communications Council (IMCC), the trade association that represents PCOs. Individual PCOs often serve approximately 3,000-4,000 subscribers, but the larger operations serve as many as 15,000-55,000 subscribers. In total, PCOs currently serve approximately one million subscribers. Because these operators are not rate regulated, they are not required to file financial data with the Commission. Furthermore, we are not aware of any privately published financial information regarding these operators. Based on the estimated number of operators and the estimated number of units served by the largest ten PCOs, we believe that a substantial number of PCOs may qualify as small entities.
        24. Home Satellite Dish (“HSD”) Service. Because HSD provides subscription services, HSD falls within the SBA-recognized definition of Cable and Other Program Distribution, which includes all such companies generating $13.5 million or less in revenue annually. HSD or the large dish segment of the satellite industry is the original satellite-to-home service offered to consumers, and involves the home reception of signals transmitted by satellites operating generally in the C-band frequency. Unlike DBS, which uses small dishes, HSD antennas are between four and eight feet in diameter and can receive a wide range of unscrambled (free) programming and scrambled programming purchased from program packagers that are licensed to facilitate subscribers'  receipt of video programming. There are approximately 30 satellites operating in the C-band, which carry over 500 channels of programming combined; approximately 350 channels are available free of charge and 150 are scrambled and require a subscription. HSD is difficult to quantify in terms of annual revenue. HSD owners have access to program channels placed on C-band satellites by programmers for receipt and distribution by MVPDs. Commission data shows that, between June 2004 and June 2005, HSD subscribership fell from 335,766 subscribers to 206,358 subscribers, a decline of more than 38 percent. The Commission has no information regarding the annual revenue of the four C-Band distributors.
        25. Broadband Radio Service and Educational Broadband Service. Broadband Radio Service comprises Multichannel Multipoint Distribution Service (MMDS) systems and Multipoint Distribution Service (MDS). MMDS systems, often referred to as “wireless cable,” transmit video programming to subscribers using the microwave frequencies of MDS and Educational Broadband Service (EBS) (formerly known as Instructional Television Fixed Service (ITFS)). We estimate that the number of wireless cable subscribers is approximately 100,000, as of March 2005. The SBA definition of small entities for Cable and Other Program Distribution, which includes such companies generating $13.5 million in annual receipts, appears applicable to MDS and ITFS.
        26. The Commission has also defined small MDS (now BRS) entities in the context of Commission license auctions. For purposes of the 1996 MDS auction, the Commission defined a small business as an entity that had annual average gross revenues of less than $40 million in the previous three calendar years. This definition of a small entity in the context of MDS auctions has been approved by the SBA. In the MDS auction, 67 bidders won 493 licenses. Of the 67 auction winners, 61 claimed status as a small business. At this time, the Commission estimates that of the 61 small business MDS auction winners, 48 remain small business licensees. In addition to the 48 small businesses that hold BTA authorizations, there are approximately 392 incumbent MDS licensees that have gross revenues that are not more than $40 million and are thus considered small entities. MDS licensees and wireless cable operators that did not receive their licenses as a result of the MDS auction fall under the SBA small business size standard for Cable and Other Program Distribution, which includes all such entities that do not generate revenue in excess of $13.5 million annually. Information available to us indicates that there are approximately 850 of these licensees and operators that do not generate revenue in excess of $13.5 million annually. Therefore, we estimate that there are approximately 850 small entity MDS (or BRS) providers, as defined by the SBA and the Commission's auction rules.
        27. Educational institutions are included in this analysis as small entities; however, the Commission has not created a specific small business size standard for ITFS (now EBS). We estimate that there are currently 2,032 ITFS (or EBS) licensees, and all but 100 of the licenses are held by educational institutions. Thus, we estimate that at least 1,932 ITFS licensees are small entities.
        28. Local Multipoint Distribution Service. Local Multipoint Distribution Service (LMDS) is a fixed broadband point-to-multipoint microwave service that provides for two-way video telecommunications. The SBA definition of small entities for Cable and Other Program Distribution, which includes such companies generating $13.5 million in annual receipts, appears applicable to LMDS. The Commission has also defined small LMDS entities in the context of Commission license auctions. In the 1998 and 1999 LMDS auctions, the Commission defined a small business as an entity that had annual average gross revenues of less than $40 million in the previous three calendar years. Moreover, the Commission added an additional classification for a “very small business,” which was defined as an entity that had annual average gross revenues of less than $15 million in the previous three calendar years. These definitions of “small business” and “very small business” in the context of the LMDS auctions have been approved by the SBA. In the first LMDS auction, 104 bidders won 864 licenses. Of the 104 auction winners, 93 claimed status as small or very small businesses. In the LMDS re-auction, 40 bidders won 161 licenses. Based on this information, we believe that the number of small LMDS licenses will include the 93 winning bidders in the first auction and the 40 winning bidders in the re-auction, for a total of 133 small entity LMDS providers as defined by the SBA and the Commission's auction rules.
        29. Open Video Systems (“OVS”). The OVS framework provides opportunities for the distribution of video programming other than through cable systems. Because OVS operators provide subscription services, OVS falls within the SBA-recognized definition of Cable and Other Program Distribution Services, which provides that a small entity is one with $ 13.5 million or less in annual receipts. The Commission has approved approximately 120 OVS certifications with some OVS operators now providing service. Broadband service providers (BSPs) are currently the only significant holders of OVS certifications or local OVS franchises, even though OVS is one of four statutorily-recognized options for local exchange carriers (LECs) to offer video programming services. As of June 2005, BSPs served approximately 1.4 million subscribers, representing 1.49 percent of all MVPD households. Among BSPs, however, those operating under the OVS framework are in the minority. As of June 2005, RCN Corporation is the largest BSP and 14th largest MVPD, serving approximately 371,000 subscribers. RCN received approval to operate OVS systems in New York City, Boston, Washington, D.C. and other areas. The Commission does not have financial information regarding the entities authorized to provide OVS, some of which may not yet be operational. We thus believe that at least some of the OVS operators may qualify as small entities.
        30. Cable and Other Subscription Programming. The Census Bureau defines this category as follows: “This industry comprises establishments primarily engaged in operating studios and facilities for the broadcasting of programs on a subscription or fee basis * *. These establishments produce programming in their own facilities or acquire programming from external sources. The programming material is usually delivered to a third party, such as cable systems or direct-to-home satellite systems, for transmission to viewers.” The SBA has developed a small business size standard for firms within this category, which is all firms with $13.5 million or less in annual receipts. According to Census Bureau data for 2002, there were 270 firms in this category that operated for the entire year. Of this total, 217 firms had annual receipts of under $10 million and 13 firms had annual receipts of $10 million to $24,999,999. Thus, under this category and associated small business size standard, the majority of firms can be considered small.
        31. Motion Picture and Video Production. The Census Bureau defines this category as follows: “This industry comprises establishments primarily engaged in producing, or producing and distributing motion pictures, videos, television programs, or television commercials.” The SBA has developed a small business size standard for firms within this category, which is all firms with $27 million or less in annual receipts. According to Census Bureau data for 2002, there were 7,772 firms in this category that operated for the entire year. Of this total, 7,685 firms had annual receipts of under $24,999,999 and 45 firms had annual receipts of between $25,000,000 and $49,999,999. Thus, under this category and associated small business size standard, the majority of firms can be considered small. Each of these NAICS categories is very broad and includes firms that may be engaged in various industries, including cable programming. Specific figures are not available regarding how many of these firms exclusively produce and/or distribute programming for cable television or how many are independently owned and operated.
        32. Motion Picture and Video Distribution. The Census Bureau defines this category as follows: “This industry comprises establishments primarily engaged in acquiring distribution rights and distributing film and video productions to motion picture theaters, television networks and stations, and exhibitors.” The SBA has developed a small business size standard for firms within this category, which is all firms with $27 million or less in annual receipts. According to Census Bureau data for 2002, there were 377 firms in this category that operated for the entire year. Of this total, 365 firms had annual receipts of under $24,999,999 and 7 firms had annual receipts of between $25,000,000 and $49,999,999. Thus, under this category and associated small business size standard, the majority of firms can be considered small. Each of these NAICS categories is very broad and includes firms that may be engaged in various industries, including cable programming. Specific figures are not available regarding how many of these firms exclusively produce and/or distribute programming for cable television or how many are independently owned and operated.
        33. Small Incumbent Local Exchange Carriers. We have included small incumbent local exchange carriers in this present RFA analysis. A “small business” under the RFA is one that, inter alia, meets the pertinent small business size standard (e.g., a telephone communications business having 1,500 or fewer employees), and “is not dominant in its field of operation.” The SBA's Office of Advocacy contends that, for RFA purposes, small incumbent local exchange carriers are not dominant in their field of operation because any such dominance is not “national” in scope. We have therefore included small incumbent local exchange carriers in this RFA, although we emphasize that this RFA action has no effect on Commission analyses and determinations in other, non-RFA contexts.
        34. Incumbent Local Exchange Carriers (“LECs”). Neither the Commission nor the SBA has developed a small business size standard specifically for incumbent local exchange services. The appropriate size standard under SBA rules is for the category Wired Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 1,307 carriers have reported that they are engaged in the provision of incumbent local exchange services. Of these 1,307 carriers, an estimated 1,019 have 1,500 or fewer employees and 288 have more than 1,500 employees. Consequently, the Commission estimates that most providers of incumbent local exchange service are small businesses.
        35. Competitive Local Exchange Carriers, Competitive Access Providers (CAPs), Shared-Tenant Service Providers,” and “Other Local Service Providers.” Neither the Commission nor the SBA has developed a small business size standard specifically for these service providers. The appropriate size standard under SBA rules is for the category Wired Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 859 carriers have reported that they are engaged in the provision of either competitive access provider services or competitive local exchange carrier services. Of these 859 carriers, an estimated 741 have 1,500 or fewer employees and 118 have more than 1,500 employees. In addition, 16 carriers have reported that they are “Shared-Tenant Service Providers,” and all 16 are estimated to have 1,500 or fewer employees. In addition, 44 carriers have reported that they are “Other Local Service Providers.” Of the 44, an estimated 43 have 1,500 or fewer employees and one has more than 1,500 employees. Consequently, the Commission estimates that most providers of competitive local exchange service, competitive access providers, “Shared-Tenant Service Providers,” and “Other Local Service Providers” are small entities.
        36. Electric Power Generation, Transmission and Distribution. The Census Bureau defines this category as follows: “This industry group comprises establishments primarily engaged in generating, transmitting, and/or distributing electric power. Establishments in this industry group may perform one or more of the following activities: (1) Operate generation facilities that produce electric energy; (2) operate transmission systems that convey the electricity from the generation facility to the distribution system; and (3) operate distribution systems that convey electric power received from the generation facility or the transmission system to the final consumer.” The SBA has developed a small business size standard for firms in this category: “A firm is small if, including its affiliates, it is primarily engaged in the generation, transmission, and/or distribution of electric energy for sale and its total electric output for the preceding fiscal year did not exceed 4 million megawatt hours.” According to Census Bureau data for 2002, there were 1,644 firms in this category that operated for the entire year. Census data do not track electric output and we have not determined how many of these firms fit the SBA size standard for small, with no more than 4 million megawatt hours of electric output. Consequently, we estimate that 1,644 or fewer firms may be considered small under the SBA small business size standard.
        D. Description of Proposed Reporting, Recordkeeping and Other Compliance Requirements
        37. The rules ultimately adopted as a result of this FNPRM may contain new or modified information collections. We anticipate that none of the changes would result in an increase to the reporting and recordkeeping requirements of small entities. We invite small entities to comment in response to the FNPRM.
        E. Steps Taken To Minimize Significant Impact on Small Entities and Significant Alternatives Considered
        38. The RFA requires an agency to describe any significant alternatives that it has considered in proposing regulatory approaches, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.
        39. In response to the FNPRM, the Commission may choose to continue to apply its current leased access rates to programmers that predominantly transmit sales presentations or program length commercials; it may choose to apply the modified rate formula and the maximum allowable leased access rate of $0.10 per subscriber per month to these programmers; or it may adopt an alternative approach. We invite comment on the options the Commission is considering, or alternatives thereto as referenced above, and on any other alternatives commenters may wish to propose for the purpose of minimizing any significant economic impact on smaller entities.
        F. Federal Rules Which Duplicate, Overlap, or Conflict With the Commission's Proposals
        40. None.
        IV. Additional Information

        41. For additional information on this proceeding, contact Steven Broeckaert, Steven.Broeckaert@fcc.gov; or Katie Costello, Katie.Costello@fcc.gov; of the Media Bureau, Policy Division, (202) 418-2120.
        V. Ordering Clauses
        42. Accordingly, it is ordered, pursuant to the authority found in sections 4(i), 303(r), and 628 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 303(r), and 532, this Notice of Proposed Rulemaking Is Adopted.

        43. It is further ordered that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Notice of Proposed Rulemaking, including the Initial Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

          Federal Communications Commission.
          Marlene H. Dortch,
           Secretary.

      [FR Doc. 08-871 Filed 2-27-08; 8:45 am]
      BILLING CODE 6712-01-P


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 229
        [Docket No. 180702603-8603-01]
        RIN 0648-BH98
        Advance Notice of Proposed Rulemaking; Request for Information

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

          ACTION:
          Advance notice of proposed rulemaking.

          SUMMARY:
          NMFS hereby publishes an advance notice of proposed rulemaking to solicit comments on modifying the Atlantic Large Whale Take Reduction Plan's Massachusetts Trap/Pot Restricted Area and the Great South Channel Trap/Pot Restricted Area to allow trap/pot fishing that does not use vertical buoy lines (referred to as buoy-lineless or ropeless gear) prior to gear retrieval. NMFS is requesting comments on this possible action including whether opening these areas that are currently closed to trap/pot fishing would provide an economic benefit or incentive for buoy-lineless fishing development and to assess interest from industry for buoy-lineless fishing in these areas.

          DATES:
          Information related to this document must be received by close of business on October 29, 2018.

          ADDRESSES:
          You may submit comments by any of the following methods:

            Electronic Submission: Submit all electronic public comments via the Federal e-rulemaking Portal.
          1. Go to www.regulations.gov/#!docketDetail;D=www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2018-0082.

          2. Click the “Comment Now!” icon, complete the required fields.
          3. Enter or attach your comments.

        -OR-

          Mail: Submit written comments to Michael Pentony, Regional Administrator, National Marine Fisheries Service, 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 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 other sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

          FOR FURTHER INFORMATION CONTACT:

          Allison Rosner NMFS Protected Resources Division, Greater Atlantic Region, 978-282-8462, allison.rosner@noaa.gov or Kristy Long, NMFS Office of Protected Resources, 301-427-8402, kristy.long@noaa.gov.

        SUPPLEMENTARY INFORMATION:

        Background

        Large whale entanglements resulting in mortalities and serious injuries still occur at levels that, for North Atlantic right whales, exceed the allowable levels established by the Marine Mammal Protection Act (MMPA). Under the MMPA, NMFS is required to reduce the mortality and serious injury to three strategic large whale stocks—the Western Stock of North Atlantic right whales (Eubalaena glacialis), the Gulf of Maine stock of humpback whales (Megaptera novaeangliea), and the Western North Atlantic stock of fin whales (Balaenoptera physalus)—incidentally taken in commercial fisheries to below the potential biological removal level for each stock.
        Currently the Atlantic Large Whale Take Reduction Plan (Plan) has two seasonal trap/pot closures: Massachusetts Restricted Area (50 CFR 229.32(c)(3)) and the Great South Channel Trap/Pot Closure (50 CFR 229.32(c)(4)). Massachusetts Restricted Area prohibits fishing with, setting, or possessing trap/pot gear in this area unless stowed in accordance with § 229.2 from February 1 to April 30. Great South Channel Trap/Pot Closure prohibits fishing with, setting, or possessing trap/pot gear in this area unless stowed in accordance with § 229.2 from April 1 through June 30.
        In 2003, the Atlantic Large Whale Take Reduction Team (Team) agreed to manage entanglement risk by first reducing the risk associated with groundlines and then reducing the risk associated with vertical lines in commercial trap/pot and gillnet gear. Risk reduction of groundlines was addressed in October 2007 with the implementation of the sinking groundline requirement for all fisheries throughout the east coast (72 FR 57104, October 5, 2007). In 2009, at the request of the Team, NMFS also investigated the feasibility of opening a buoy-lineless (or ropeless) fishing gear testing site in the Great South Channel trap/pot and gillnet closure area. At the time, the Agency determined that technological and economic incentives were not sufficient for this to be successful, and that other management actions to reduce entanglement risks caused by vertical lines should be prioritized.

        In 2014, the Plan was amended (79 FR 36586, June 27, 2014) to address large whale entanglement risks associated with vertical line (or buoy lines) from commercial trap/pot fisheries. This amendment included gear modifications, gear setting requirements, an expanded seasonal trap/pot closure (Massachusetts Restricted Area) and gear marking for both trap/pot and gillnet fisheries. The original Massachusetts Restricted Area was a seasonal closure from January 1 through April 30 for all trap/pot fisheries. In a subsequent Plan amendment, the boundary for the Massachusetts Restricted Area was expanded by 900 square miles (2.59 square kilometers), and the start date changed to February 1 (79 FR 73848, December 12, 2014).

        In response to continued North Atlantic right whale population decline and associated entanglements as well as recent technological developments with ropeless fishing design, NMFS convened a subgroup to investigate the feasibility of buoy lineless options that may help reduce future entanglement risk. The “ALWTRT Ropeless Feasibility Subgroup” met March 15-16, 2018, in Providence, RI, to assess the current research available on ropeless fishing gear prototypes, the feasibility of this technology, and discuss data gaps. From this meeting, the subgroup suggested that the Team and NMFS revisit the previous discussion to open closed areas to buoy-lineless trap/pot fishing. This could incentivize cooperative research that may lead to further technological developments for buoy-lineless fishing.

        This notice announces the Agency's preparation for possible rulemaking and associated analysis of changing the Massachusetts Restricted Area and Great South Channel closures to buoy-lineless trap/pot gear areas under the MMPA and to request comments and information regarding this possibility. In order to commercially fish in these areas, fishermen must still comply with the Federal American lobster regulations, state regulations, and other Plan requirements (e.g. use of sinking groundlines). Given the surface system requirements (e.g. mandated radar reflector use) under the Interstate Fishery Management Plan for American Lobster, in order to participate in trap/pot fishing that does not use vertical lines except during the active haul back of gear, interested parties with federal permits will be required to apply for an Exempted Fishing Permit (EFP) under the authority of the Magnuson-Stevens Fishery Conservation and Management Act. EFPs may be issued for activities in support of fisheries-related research. When applying for an EFP, the applicant must include information on the research plan including principal investigator, project objectives, research description, gear and effort information, participating vessel information, any anticipated impacts on marine mammals or endangered species, and exemptions requested. If an EFP is authorized, trip reporting and project summary reports will also be required, and conditions on number of participants or traps or on areas of experimental fishing may be required. EFPs apply to Federal waters only; however, Plan requirements apply to both state and federal waters. Therefore, additional exemptions and restrictions from state regulations will be required from the applicable state authority. States may choose to adopt the Team conditions when granting these state authorizations. More information on EFPs can be found on GARFO's website: www.greateratlantic.fisheries.noaa.gov/sustainable/research/.

        Findings from this ANPR and supporting analyses will be presented at an upcoming Team meeting (scheduled for October 2018) for consideration. If at that time the Team recommends that NMFS move forward with allowing the experimentation of buoy-lineless fishing within the closure areas, NMFS will work with the Team to develop best practices that may be considered as conditions under the EFP (e.g., ideal locations within the management areas, ways to reduce gear conflict with other fixed or mobile gears, reporting to law enforcement, etc.). This guidance will be useful for EFP applicants developing the research plans required by the application process. Notices of our preliminary determination to approve an EFP are published in the Federal Register for a 15-day public comment period; therefore, the public will have an opportunity to review and comment upon any such requests. If the Team recommends this approach, this Advance Notice of Proposed Rulemaking will be followed by a proposed and final rulemaking.
        Request for Comments
        NMFS requests comments on potential impacts from this initiative including economic and habitat impacts, best discrete locations for vertical lineless trap/pot fishing, ways gear conflicts can be reduced, other guidelines for ropeless gear use to consider in the development of best practices, and to solicit industry interest for participating in these types of fisheries. NMFS also requests expressions of interest from potential applicants.

          Authority:
           16 U.S.C. 1361 et seq.

          Dated: September 24, 2018.
          Samuel D. Rauch, III,
          Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

      [FR Doc. 2018-21115 Filed 9-27-18; 8:45 am]
       BILLING CODE 3510-22-P


        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 55
        [OAR-2004-0091; FRL-9093-9]
        Outer Continental Shelf Air Regulations Consistency Update for California

          AGENCY:
          Environmental Protection Agency (“EPA”).

          ACTION:
          Proposed rule.

          SUMMARY:
          EPA is proposing to update a portion of the Outer Continental Shelf (“OCS”) Air Regulations. Requirements applying to OCS sources located within 25 miles of States' seaward boundaries must be updated periodically to remain consistent with the requirements of the corresponding onshore area (“COA”), as mandated by section 328(a)(1) of the Clean Air Act, as amended in 1990 (“the Act”). The portion of the OCS air regulations that is being updated pertains to the requirements for OCS sources for which the South Coast Air Quality Management District (“South Coast AQMD” or “District”) is the designated COA. The intended effect of approving the OCS requirements for the South Coast AQMD is to regulate emissions from OCS sources in accordance with the requirements onshore. The changes to the existing requirements discussed below are proposed to be incorporated by reference into the Code of Federal Regulations and listed in the appendix to the OCS air regulations.

          DATES:
          Any comments must arrive by January 20, 2010.

          ADDRESSES:
          Submit comments, identified by docket number OAR-2004-0091, by one of the following methods:
          1. Federal eRulemaking Portal:  http://www.regulations.gov. Follow the on-line instructions.
          2. E-mail: steckel.andrew@epa.gov.
          3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA 94105-3901.

            Instructions: All comments will be included in the public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted through http://www.regulations.gov or e-mail. http://www.regulations.gov is an “anonymous access” system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send e-mail directly to EPA, your e-mail address will be automatically captured and included as part of the public comment. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

            Docket: The index to the docket for this action is available electronically at http://www.regulations.gov and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section.

          FOR FURTHER INFORMATION CONTACT:

          Cynthia G. Allen, Air Division (Air-4), U.S. EPA Region 9, 75 Hawthorne Street, San Francisco, CA 94105, (415) 947-4120, allen.cynthia@epa.gov.

        SUPPLEMENTARY INFORMATION:
        Table of Contents

          I. Background and Purpose
          II. EPA's Evaluation
          III. Proposed Action
          IV. Statutory and Executive Order Reviews

        I. Background and Purpose
        On September 4, 1992, EPA promulgated 40 CFR part 55,1
           which established requirements to control air pollution from OCS sources in order to attain and maintain Federal and State ambient air quality standards and to comply with the provisions of part C of title I of the Act. Part 55 applies to all OCS sources offshore of the States except those located in the Gulf of Mexico west of 87.5 degrees longitude. Section 328 of the Act requires that for such sources located within 25 miles of a State's seaward boundary, the requirements shall be the same as would be applicable if the sources were located in the COA. Because the OCS requirements are based on onshore requirements, and onshore requirements may change, section 328(a)(1) requires that EPA update the OCS requirements as necessary to maintain consistency with onshore requirements.

            1 See Notice of Proposed Rulemaking, December 5, 1991 (56 FR 63774), and the preamble to the final rule promulgated September 4, 1992 (57 FR 40792) for further background and information on the OCS regulations.

        Pursuant to section 55.12 of the OCS rule, consistency reviews will occur (1) At least annually; (2) upon receipt of a Notice of Intent under section 55.4; or (3) when a State or local agency submits a rule to EPA to be considered for incorporation by reference in part 55. This proposed action is being taken in response to the submittal of requirements by the South Coast AQMD. Public comments received in writing within 30 days of publication of this document will be considered by EPA before publishing a final rule.

        Section 328(a) of the Act requires that EPA establish requirements to control air pollution from OCS sources located within 25 miles of States' seaward boundaries that are the same as onshore requirements. To comply with this statutory mandate, EPA must incorporate applicable onshore rules into part 55 as they exist onshore. This limits EPA's flexibility in deciding which requirements will be incorporated into part 55 and prevents EPA from making substantive changes to the requirements it incorporates. As a result, EPA may be incorporating rules into part 55 that do not conform to all of EPA's State implementation plan (SIP) guidance or certain requirements of the Act. Consistency updates may result in the inclusion of State or local rules or regulations into part 55, even though the same rules may ultimately be disapproved for inclusion as part of the SIP. Inclusion in the OCS rule does not imply that a rule meets the requirements of the Act for SIP approval, nor does it imply that the rule will be approved by EPA for inclusion in the SIP.
        II. EPA's Evaluation
        In updating 40 CFR part 55, EPA reviewed the rules submitted for inclusion in part 55 to ensure that they are rationally related to the attainment or maintenance of Federal or State ambient air quality standards or part C of title I of the Act, that they are not designed expressly to prevent exploration and development of the OCS and that they are applicable to OCS sources. 40 CFR 55.1. EPA has also evaluated the rules to ensure they are not arbitrary or capricious. 40 CFR 55.12(e). EPA has excluded rules that regulate toxics, which are not related to the attainment and maintenance of Federal and State ambient air quality standards.

        EPA is soliciting public comments on the issues discussed in this document or on other relevant matters. EPA will consider these comments before taking final action. Interested parties may participate in the Federal rulemaking procedure by submitting written comments to the EPA Region IX Office listed in the ADDRESSES section of this Federal Register.
        III. Proposed Action
        1. After review of the requirements submitted by the South Coast AQMD against the criteria set forth above and in 40 CFR part 55, EPA is proposing to make the following District requirements applicable to OCS sources. Earlier versions of these District rules are currently implemented on the OCS:

            Rule #
            Name
            Adoption or amended date

            301
            Permit Fees
            05/02/08

            304
            Equipment, Materials, and Ambient Air Analyses
            05/02/08

            304.1
            Analyses Fees
            05/02/08

            306
            Plan Fees
            05/02/08

            309
            Fees for Regulation XVI
            05/02/08

            Regulation IX
            Standards of Performance for New Stationary Sources
            04/04/08

            Regulation X
            National Emission Standards for Hazardous Air Pollutants
            04/04/08

            1110.2
            Emissions from Gaseous- and Liquid-Fueled Engines
            02/01/08

            1113
            Architectural Coatings
            07/13/07

            1146
            Emissions of Oxides of Nitrogen from Industrial, Institutional, and Commercial Boilers, Steam Generators, and Process Heaters
            09/05/08

            1146.1
            Emissions of Oxides of Nitrogen from Small Industrial, Institutional, and Commercial Boilers, Steam Generators, and Process Heaters
            09/05/08

            1149
            Storage Tank and Pipeline Cleaning and Degassing
            05/02/08

            1171
            Solvent Cleaning Operations
            02/01/08

            1403
            Asbestos Emissions from Demolition/Renovation Activities
            10/05/07

        The District also submitted the following new rules which are not currently in effect on the OCS, for incorporation into part 55. We are proposing to incorporate these rules into part 55:

            303
            Hearing Board Fees
            05/02/08

            313
            Authority To Adjust Fees and Due Dates
            05/02/08

            1309.1
            Priority Reserve (Replaced)
            08/03/07

            1315
            Federal New Source Review Tracking System (Readopted)
            08/03/07

            1472
            Requirements for Facilities with Multiple Stationary Emergency Standby Diesel-Fueled Internal Combustion Engines
            03/07/08

            2449
            Control of Oxides of Nitrogen Emissions from Off-Road Diesel Vehicles
            05/02/08

        EPA is proposing not to incorporate into part 55 the following rule submitted by the South Coast AQMD, because it regulates toxics and is not rationally related to the attainment and maintenance of Federal or State ambient air quality standards or part C of title I of the Act:

            1401
            New Source Review of Toxic Air Contaminants
            03/07/08

        IV. Statutory and Executive Order Reviews
        A. Executive Order 12866: Regulatory Planning and Review
        Under the Clean Air Act, the Administrator is required to establish requirements to control air pollution from OCS sources located within 25 miles of States' seaward boundaries that are the same as onshore air control requirements. To comply with this statutory mandate, EPA must incorporate applicable onshore rules into part 55 as they exist onshore. 42 U.S.C. 7627(a)(1); 40 CFR 55.12. Thus, in promulgating OCS consistency updates, EPA's role is to maintain consistency between OCS regulations and the regulations of onshore areas, provided that they meet the criteria of the Clean Air Act. Accordingly, this action simply proposes to update the existing OCS requirements to make them consistent with requirements onshore, without the exercise of any policy discretion by EPA. For that reason, this proposed action:
        • Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

        • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

        • Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
        • Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
        • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
        • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
        • Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
        • Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
        In addition, this proposed rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, nor does it impose substantial direct compliance costs on tribal governments, nor preempt tribal law.

        Under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in 40 CFR part 55 and, by extension, this update to the rules, and has assigned OMB control number 2060-0249. Notice of OMB's approval of EPA Information Collection Request (“ICR”) No. 1601.07 was published in the Federal Register on February 17, 2009 (74 FR 7432). The approval expires January 31, 2012. As EPA previously indicated (70 FR 65897-65898 (November 1, 2005)), the annual public reporting and recordkeeping burden for collection of information under 40 CFR part 55 is estimated to average 549 hours per response, using the definition of burden provided in 44 U.S.C. 3502(2).

          List of Subjects in 40 CFR Part 55
          Environmental protection, Administrative practice and procedure, Air pollution control, Hydrocarbons, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Nitrogen oxides, Outer Continental Shelf, Ozone, Particulate matter, Permits, Reporting and recordkeeping requirements, Sulfur oxides.

          Dated: December 1, 2009.
          Laura Yoshii,
          Acting Regional Administrator, Region IX.

        Title 40 of the Code of Federal Regulations, part 55, is proposed to be amended as follows:

          PART 55—[AMENDED]
          1. The authority citation for part 55 continues to read as follows:

            Authority:
             Section 328 of the Clean Air Act (42 U.S.C. 7401 et seq.) as amended by Pub. L. 101-549.

          2. Section 55.14 is amended by revising paragraph (e)(3)(ii)(G) to read as follows:

            § 55.14
            Requirements that apply to OCS sources located within 25 miles of states seaward boundaries, by state.

            (e)  * * *
            (3)  * * *
            (ii)  * * *
            (G) South Coast Air Quality Management District Requirements Applicable to OCS Sources (Parts I, II and III), September 2009.

            3. Appendix A to CFR Part 55 is amended by revising paragraph (b)(7) under the heading “California” to read as follows:

              Appendix A to Part 55—Listing of State and Local Requirements Incorporated by Reference Into Part 55, by State

              California

              (b)  * * *
              (7) The following requirements are contained in South Coast Air Quality Management District Requirements Applicable to OCS Sources (Part I, II and III):

              Rule 102 Definition of Terms (Adopted 12/3/04)
              Rule 103 Definition of Geographical Areas (Adopted 01/9/76)
              Rule 104 Reporting of Source Test Data and Analyses (Adopted 01/9/76)
              Rule 108 Alternative Emission Control Plans (Adopted 04/6/90)
              Rule 109 Recordkeeping for Volatile Organic Compound Emissions (Adopted 08/18/00)
              Rule 112 Definition of Minor Violation and Guidelines for Issuance of Notice to Comply (Adopted 11/13/98)
              Rule 118 Emergencies (Adopted 12/07/95)
              Rule 201 Permit to Construct (Adopted 12/03/04)
              Rule 201.1 Permit Conditions in Federally Issued Permits to Construct (Adopted 12/03/04)
              Rule 202 Temporary Permit to Operate (Adopted 12/03/04)
              Rule 203 Permit to Operate (Adopted 12/03/04)
              Rule 204 Permit Conditions (Adopted 03/6/92)
              Rule 205 Expiration of Permits to Construct (Adopted 01/05/90)
              Rule 206 Posting of Permit to Operate (Adopted 01/05/90)
              Rule 207 Altering or Falsifying of Permit (Adopted 01/09/76)
              Rule 208 Permit and Burn Authorization for Open Burning (Adopted 12/21/01)
              Rule 209 Transfer and Voiding of Permits (Adopted 01/05/90)
              Rule 210 Applications (Adopted 01/05/90)
              Rule 212 Standards for Approving Permits (Adopted 12/07/95) except (c)(3) and (e)
              Rule 214 Denial of Permits (Adopted 01/05/90)
              Rule 217 Provisions for Sampling and Testing Facilities (Adopted 01/05/90)
              Rule 218 Continuous Emission Monitoring (Adopted 05/14/99)
              Rule 218.1 Continuous Emission Monitoring Performance Specifications (Adopted 05/14/99)
              Rule 218.1 Attachment A—Supplemental and Alternative CEMS Performance Requirements (Adopted 05/14/99)
              Rule 219 Equipment Not Requiring a Written Permit Pursuant to Regulation II (Adopted 6/1/07)
              Rule 220 Exemption—Net Increase in Emissions (Adopted 08/07/81)
              Rule 221 Plans (Adopted 01/04/85)
              Rule 301 Permitting and Associated Fees (Adopted 5/2/08) except (e)(7)and Table IV
              Rule 304 Equipment, Materials, and Ambient Air Analyses (Adopted 5/2/08)
              Rule 304.1 Analyses Fees (Adopted 5/2/08)
              Rule 305 Fees for Acid Deposition (Rescinded 6/9/06)
              Rule 306 Plan Fees (Adopted 5/2/08)
              Rule 309 Fees for Regulation XVI (Adopted 5/2/08)
              Rule 313 Authority to Adjust Fees and Due Dates (Adopted 5/2/08)
              Rule 401 Visible Emissions (Adopted 11/09/01)
              Rule 403 Fugitive Dust (Adopted 06/03/05)
              Rule 404 Particulate Matter—Concentration (Adopted 02/07/86)
              Rule 405 Solid Particulate Matter—Weight (Adopted 02/07/86)
              Rule 407 Liquid and Gaseous Air Contaminants (Adopted 04/02/82)
              Rule 408 Circumvention (Adopted 05/07/76)
              Rule 409 Combustion Contaminants (Adopted 08/07/81)
              Rule 429 Start-Up and Shutdown Exemption Provisions for Oxides of Nitrogen (Adopted 12/21/90)
              Rule 430 Breakdown Provisions, (a) and (b) only (Adopted 07/12/96)
              Rule 431.1 Sulfur Content of Gaseous Fuels (Adopted 06/12/98)

              Rule 431.2 Sulfur Content of Liquid Fuels (Adopted 09/15/00)

              Rule 431.3 Sulfur Content of Fossil Fuels (Adopted 05/7/76)
              Rule 441 Research Operations (Adopted 05/7/76)
              Rule 442 Usage of Solvents (Adopted 12/15/00)
              Rule 444 Open Burning (Adopted 12/21/01)
              Rule 463 Organic Liquid Storage (Adopted 05/06/05)
              Rule 465 Refinery Vacuum-Producing Devices or Systems (Adopted 08/13/99)
              Rule 468 Sulfur Recovery Units (Adopted 10/08/76)
              Rule 473 Disposal of Solid and Liquid Wastes (Adopted 05/07/76)
              Rule 474 Fuel Burning Equipment-Oxides of Nitrogen (Adopted 12/04/81)
              Rule 475 Electric Power Generating Equipment (Adopted 08/07/78)
              Rule 476 Steam Generating Equipment (Adopted 10/08/76)
              Rule 480 Natural Gas Fired Control Devices (Adopted 10/07/77) Addendum to Regulation IV (Effective 1977)
              Rule 518 Variance Procedures for Title V Facilities (Adopted 08/11/95)
              Rule 518.1 Permit Appeal Procedures for Title V Facilities (Adopted 08/11/95)
              Rule 518.2 Federal Alternative Operating Conditions (Adopted 12/21/01)
              Rule 701 Air Pollution Emergency Contingency Actions (Adopted 06/13/97)
              Rule 702 Definitions (Adopted 07/11/80)
              Rule 708 Plans (Rescinded 09/08/95)
              Regulation IX Standard of Performance for New Stationary Sources (Adopted 4/4/08)
              Regulation X National Emission Standards for Hazardous Air Pollutants (Adopted 4/4/08)
              Rule 1105.1 Reduction of PM10 And Ammonia Emissions From Fluid Catalytic Cracking Units (Adopted 11/07/03)
              Rule 1106 Marine Coating Operations (Adopted 01/13/95)
              Rule 1107 Coating of Metal Parts and Products (Adopted 1/6/06)
              Rule 1109 Emissions of Oxides of Nitrogen for Boilers and Process Heaters in Petroleum Refineries (Adopted 08/05/88)
              Rule 1110 Emissions from Stationary Internal Combustion Engines (Demonstration) (Repealed 11/14/97)
              Rule 1110.1 Emissions from Stationary Internal Combustion Engines (Rescinded 06/03/05)
              Rule 1110.2 Emissions from Gaseous-and Liquid Fueled Engines (Adopted 2/1/08)
              Rule 1113 Architectural Coatings (Adopted 7/13/07)
              Rule 1116.1 Lightering Vessel Operations-Sulfur Content of Bunker Fuel (Adopted 10/20/78)
              Rule 1121 Control of Nitrogen Oxides from Residential-Type Natural Gas-Fired Water Heaters (Adopted 09/03/04)
              Rule 1122 Solvent Degreasers (Adopted 10/01/04)
              Rule 1123 Refinery Process Turnarounds (Adopted 12/07/90)
              Rule 1125 Metal Container, Closure, and Coil Coating Operations (Adopted 3/7/08)
              Rule 1129 Aerosol Coatings (Adopted 03/08/96)
              Rule 1132 Further Control of VOC Emissions from High-Emitting Spray Booth Facilities (Adopted 5/5/06)
              Rule 1134 Emissions of Oxides of Nitrogen from Stationary Gas Turbines (Adopted 08/08/97)
              Rule 1136 Wood Products Coatings (Adopted 06/14/96)
              Rule 1137 PM10 Emission Reductions from Woodworking Operations (Adopted 02/01/02)
              Rule 1140 Abrasive Blasting (Adopted 08/02/85)
              Rule 1142 Marine Tank Vessel Operations (Adopted 07/19/91)
              Rule 1146 Emissions of Oxides of Nitrogen from Industrial, Institutional, and Commercial Boilers, Steam Generators, and Process Heaters (Adopted 9/5/08)
              Rule 1146.1 Emission of Oxides of Nitrogen from Small Industrial, Institutional, and Commercial Boilers, Steam Generators, and Process Heaters (Adopted 9/5/08)
              Rule 1146.2 Emissions of Oxides of Nitrogen from Large Water Heaters and Small Boilers (Adopted 5/5/06)
              Rule 1148 Thermally Enhanced Oil Recovery Wells (Adopted 11/05/82)
              Rule 1149 Storage Tank Cleaning and Degassing (Adopted 5/2/08)
              Rule 1162 Polyester Resin Operations (Adopted 7/8/05)
              Rule 1168 Adhesive and Sealant Applications (Adopted 01/07/05)
              Rule 1171 Solvent Cleaning Operations (Adopted 2/1/08)
              Rule 1173 Control of Volatile Organic Compounds Leaks and Releases From Components at Petroleum Facilities and Chemical Plants (Adopted 6/1/07)
              Rule 1175 Control of Emissions from the Manufacture of Polymeric Cellular (Foam) Products (Adopted 9/7/07)
              Rule 1176 VOC Emissions from Wastewater Systems (Adopted 09/13/96)
              Rule 1178 Further Reductions of VOC Emissions from Storage Tanks at Petroleum Facilities (Adopted 4/7/06)
              Rule 1301 General (Adopted 12/07/95)
              Rule 1302 Definitions (Adopted 12/06/02)
              Rule 1303 Requirements (Adopted 12/06/02)
              Rule 1304 Exemptions (Adopted 06/14/96)
              Rule 1306 Emission Calculations (Adopted 12/06/02)
              Rule 1313 Permits to Operate (Adopted 12/07/95)
              Rule 1315 Federal New Source Review Tracking System (Readopted) (Adopted 8/3/07)
              Rule 1403 Asbestos Emissions from Demolition/Renovation Activities (Adopted 10/5/07)
              Rule 1470 Requirements for Stationary Diesel-Fueled Internal Combustion and Other Compression Ignition Engines (Adopted 6/1/07)
              Rule 1472 Requirements for Facilities with Multiple Stationary Emergency Standby Diesel-Fueled Internal Combustion Engines (Adopted 3/7/08)
              Rule 1605 Credits for the Voluntary Repair of On-Road Motor Vehicles Identified Through Remote Sensing Devices (Adopted 10/11/96)
              Rule 1610 Old-Vehicle Scrapping (Adopted 7/11/08)
              Rule 1612 Credits for Clean On-Road Vehicles (Adopted 07/10/98)
              Rule 1612.1 Mobile Source Credit Generation Pilot Program (Adopted 03/16/01)
              Rule 1620 Credits for Clean Off-Road Mobile Equipment (Adopted 07/10/98)
              Rule 1701 General (Adopted 08/13/99)
              Rule 1702 Definitions (Adopted 08/13/99)
              Rule 1703 PSD Analysis (Adopted 10/07/88)
              Rule 1704 Exemptions (Adopted 08/13/99)
              Rule 1706 Emission Calculations (Adopted 08/13/99)
              Rule 1713 Source Obligation (Adopted 10/07/88)
              Regulation XVII Appendix (effective 1977)
              Rule 1901 General Conformity (Adopted 09/09/94)
              Regulation XX Regional Clean Air Incentives Market (Reclaim)
              Rule 2000 General (Adopted 05/06/05)
              Rule 2001 Applicability (Adopted 05/06/05)
              Rule 2002 Allocations for Oxides of Nitrogen (NOX) and Oxides of Sulfur (SOX) (Adopted 01/07/05)
              Rule 2004 Requirements (Adopted 4/6/07) except (l)
              Rule 2005 New Source Review for RECLAIM (Adopted 05/06/05) except (i)
              Rule 2006 Permits (Adopted 05/11/01)
              Rule 2007 Trading Requirements (Adopted 4/6/07)
              Rule 2008 Mobile Source Credits (Adopted 10/15/93)
              Rule 2009 Compliance Plan for Power Producing Facilities (Adopted 01/07/05)
              Rule 2010 Administrative Remedies and Sanctions (Adopted 4/6/07)

              Rule 2011 Requirements for Monitoring, Reporting, and Recordkeeping for Oxides of Sulfur (SOX) Emissions (Adopted 05/06/05)
              Appendix A Volume IV—(Protocol for oxides of sulfur) (Adopted 05/06/05)

              Rule 2012 Requirements for Monitoring, Reporting, and Recordkeeping for Oxides of Nitrogen (NOX) Emissions (Adopted 05/06/05)
              Appendix A Volume V—(Protocol for oxides of nitrogen) (Adopted 05/06/05)
              Rule 2015 Backstop Provisions (Adopted 06/04/04) except (b)(1)(G) and (b)(3)(B)
              Rule 2020 RECLAIM Reserve (Adopted 05/11/01)
              Rule 2100 Registration of Portable Equipment (Adopted 07/11/97)
              Rule 2449 Controls of Oxides of Nitrogen Emissions from Off-Road Diesel Vehicles (Adopted 5/2/08)
              Rule 2506 Area Source Credits for NOX and SOX (Adopted 12/10/99)
              XXX Title V Permits
              Rule 3000 General (Adopted 11/14/97)
              Rule 3001 Applicability (Adopted 11/14/97)
              Rule 3002 Requirements (Adopted 11/14/97)
              Rule 3003 Applications (Adopted 03/16/01)
              Rule 3004 Permit Types and Content (Adopted 12/12/97)
              Rule 3005 Permit Revisions (Adopted 03/16/01)
              Rule 3006 Public Participation (Adopted 11/14/97)

              Rule 3007 Effect of Permit (Adopted 10/08/93)

              Rule 3008 Potential To Emit Limitations (Adopted 03/16/01)
              XXXI Acid Rain Permit Program (Adopted 02/10/95)

      [FR Doc. E9-30154 Filed 12-18-09; 8:45 am]
      BILLING CODE 6560-50-P


        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        Food and Drug Administration
        21 CFR Part 101
        [Docket No. FDA-2016-D-2335]
        Use of the Term “Healthy” in the Labeling of Human Food Products; Public Meeting; Request for Comments

          AGENCY:
          Food and Drug Administration, HHS.

          ACTION:
          Notification of public meeting; request for comments.

          SUMMARY:
          The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled “Use of the Term `Healthy' in the Labeling of Human Food Products.” The purpose of the public meeting is to give interested persons an opportunity to discuss the use of the term “healthy” in the labeling of human food.

          DATES:

          The public meeting will be held on March 9, 2017, from 8:30 a.m. until 5:30 p.m. See section III “How to Participate in the Public Meeting” in the SUPPLEMENTARY INFORMATION section of this document for dates and times of the public meetings, closing dates for advance registration, requesting special accommodations due to disability, and other information regarding meeting participation.

          ADDRESSES:
          The public meeting will be held at the Hilton Washington DC/Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852.
          You may submit comments as follows:

        Electronic Submissions
        Submit electronic comments in the following way:
        • Federal eRulemaking Portal:
          https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

        • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
        Written/Paper Submissions
        Submit written/paper submissions as follows:
        • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
        • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

          Instructions: All submissions received must include the Docket No. FDA-2016-D-2335 for “Use of the Term `Healthy' in the Labeling of Human Food Products; Request for Information and Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

        • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

          Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

          FOR FURTHER INFORMATION CONTACT:

            For questions about registering for the meeting or to register by phone: Jim Nakayama, The Nakamoto Group, Inc., 11820 Parklawn Dr., Suite 240, Rockville, MD 20852, 301-468-6535, ext. 212, FAX: 301-468-6536, email: events@nakamotogroup.com.

            For general questions about the meeting or for special accommodations due to a disability: Juanita Yates, Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1731, email: Juanita.yates@fda.hhs.gov.

        SUPPLEMENTARY INFORMATION:

        I. Background
        In the Federal Register of September 28, 2016, we published a document inviting public comment on the possibility of redefining the “healthy” nutrient content claim for food labeling (81 FR 66562). This action was consistent with our recently released 2016-2025 Foods and Veterinary Medicine (FVM) Program's strategic plan with specific goals for nutrition and other planned and recent activity including the issuance of final rules updating certain of our nutrition labeling regulations. The document also contained several specific questions on which we sought input (81 FR 66562 at 66564 to 66565). In the Federal Register of December 30, 2016, we published a document extending the comment period for the docket to receive information and comments on the use of the term “healthy” in the labeling of human food (81 FR 96404); the comment period, which was originally scheduled to end on January 26, 2017, was extended to April 26, 2017.
        We also recently announced the availability of a guidance for industry entitled “Use of the Term `Healthy' in the Labeling of Human Food Products: Guidance to Industry” (81 FR 66527). The guidance advises manufacturers who wish to use the implied nutrient content claim “healthy” to label their food products as provided by our regulations. More specifically, the guidance advises food manufacturers of FDA's intent to exercise enforcement discretion with respect to the implied nutrient content claim “healthy” on foods that have a fat profile of predominantly mono and polyunsaturated fats, but do not meet the regulatory definition of “low fat,” or that contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.
        In addition, we received a citizen petition asking that we update, among other things, our nutrient content claim regulations to be consistent with current federal dietary guidance (see Docket No. FDA-2015-P-4564 (citizen petition from KIND LLC)). In particular, the petitioners requested that FDA amend the regulation defining the nutrient content claim “healthy” with respect to total fat intake and amend the regulation to emphasize whole foods and dietary patterns rather than specific nutrients.
        II. Purpose and Format of the Public Meeting

        We are holding the public meeting to give interested parties an opportunity to discuss the use of the term “healthy” in the labeling of human food. At the meeting, following introductory presentations, parties will have an opportunity to participate in their choice of breakout sessions on topics referenced in the notice and related documents and engage in an open comment and question and answer session. We invite interested parties to provide information, share experiences, and raise issues specifically related to the nutrient content claim “healthy,” including (but not limited to): “healthy” as a nutrient-based claim, food component-based claim, or both; “healthy” single definition or definition by category; consumer understanding of and responses to the term “healthy”; and when, if ever, the use of the term “healthy” may be false or misleading. Interested parties may also submit electronic or written comments to the docket by April 26, 2017. The agenda and other documents will be accessible on our FDA public meetings Web site at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm before the public meeting.

        In general, the meeting format will include introductory presentations, perspectives panels, and multiple opportunities for individuals to express their opinions at the meeting through oral presentations, participation in breakout sessions, and submission of electronic or written comments (see ADDRESSES for information on submitting comments). There will be an opportunity for parties who are unable to participate in person to join the meeting via Webcast. (See section III for more information on the Webcast option.)
        III. How To Participate in the Public Meeting
        Due to limited space and time, we encourage all persons who wish to attend the meeting to register in advance. There is no fee to register for the public meeting, and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited. Onsite registration will be accepted, if space permits, after all preregistered attendees are seated.
        Those requesting an opportunity to make an oral presentation during the time allotted for public comment at the meeting should submit a request in advance (see table 1 for details) and provide the specific topic or issue to be addressed. Due to the anticipated high level of interest in presenting public comment and the limited time available, we are allocating 3 minutes to each speaker to make an oral presentation. Speakers will be limited to making oral remarks; there will not be an opportunity to display materials such as slide shows, videos, or other media during the meeting. If time permits, individuals or organizations that did not register in advance may be granted the opportunity to make an oral presentation. We would like to maximize the number of individuals who make a presentation at the meeting and will do our best to accommodate all persons who wish to make a presentation or express their opinions at the meeting.

        We encourage persons and groups who have similar interests to consolidate their information for presentation by a single representative. After reviewing the presentation requests, we will notify each participant before the meeting of the approximate time their presentation is scheduled to begin, and remind them of the presentation format (i.e., 3-minute oral presentation without visual media).
        Table 1 of this document provides information on participation in the public meeting.

          Table 1—Information on Participation in the Meeting and on Submitting Comments to the Docket

            Activity
            Date
            Electronic addresses
            Address
            Other information

            Attend public meeting
            March 9, 2017, from 8:30 a.m. to 5:30 p.m
            Preregister at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm

            Registration check-in begins at 8 a.m.

            View Webcast
            March 9, 2017, from 8:30 a.m. to 5:30 p.m
            Webcast participants are asked to preregister at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm

            The Webcast will have closed captioning.

            Advance registration
            Register by March 2, 2017
            To participate in person preregister at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm

            We encourage the use of electronic registration, if possible 1

            There is no registration fee for the public meeting.

            Request to make an oral presentation
            By February 21, 2017
            To request to make an oral presentation sign-up at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm

            Submit either electronic or written comments
            Submit comments by April 26, 2017

              http://www.regulations.gov

            Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852
            See ADDRESSES for information on submitting comments.

            Request special accommodations due to a disability
            Request by February 21, 2017
            Juanita Yates, email: Juanita.yates@fda.hhs.gov

            See FOR FURTHER INFORMATION CONTACT

            1 You may also register via email, mail, or fax. Please include your name, title, firm name, address, and phone and fax numbers in your registration information and send to: Jim Nakayama (see FOR FURTHER INFORMATION CONTACT).

        IV. Transcripts and Recorded Video

        Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. The transcript will also be accessible at the Division of Dockets Management (see ADDRESSES) and FDA public meetings Web site at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.

        Additionally, we will be video recording the public meeting. Once the recorded video is available, it will be accessible on our FDA public meetings Web site at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.

          Dated: February 10, 2017.
          Leslie Kux,
          Associate Commissioner for Policy.

      [FR Doc. 2017-03117 Filed 2-15-17; 8:45 am]
      BILLING CODE 4164-01-P