        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 635
        [Docket No. 000323080-0080-01; I.D. 031500A]
        RIN 0648-AN97
        Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Angling Category

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

          ACTION:
          Advance notice of proposed rulemaking (ANPR); request for comments.

          SUMMARY:
          NMFS is requesting public comments regarding the geographical division of the Atlantic bluefin tuna (BFT) Angling category fishery and whether an adjustment of the north-south division line and an associated adjustment of the BFT subquota percentages allocated to each area is warranted. Over the last several BFT fishing seasons, fishery participants have stated to NMFS that the division line needs to be adjusted to increase the extent of recreational fishing opportunities and to divide the northern and southern areas in a manner consistent with current fishing patterns. NMFS wants to determine if a change to the current division line and subsequent reallocation of quota is needed to better coordinate domestic conservation and management of the fishery consistent with the objectives of the Fishery Management Plan for Atlantic Tunas, Swordfish, and Sharks (HMS FMP).

          DATES:
          Written comments on this ANPR are invited and must be received on or before May 22, 2000.

          ADDRESSES:
          Written comments should be sent to Rebecca Lent, Chief, Highly Migratory Species (HMS) Management Division, Office of Sustainable Fisheries (F/SF1), NMFS, 1315 East-West Highway, Silver Spring, MD 20910-3282. Comments also may be sent via facsimile (fax) to (301) 713-1917. Comments will not be accepted if submitted via e-mail or the Internet.

          FOR FURTHER INFORMATION CONTACT:
          Pat Scida or Sarah McLaughlin, (978) 281-9260.

        SUPPLEMENTARY INFORMATION:
        Atlantic tunas are managed under the dual authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) and the Atlantic Tunas Convention Act (ATCA). The ATCA authorizes the Secretary of Commerce (Secretary) to implement binding recommendations of the International Commission for the Conservation of Atlantic Tunas (ICCAT). The authority to issue regulations under the Magnuson-Stevens Act and ATCA has been delegated from the Secretary to the Assistant Administrator for Fisheries, NOAA (AA). Within NMFS, daily responsibility for management of Atlantic HMS fisheries rests with the HMS Management Division of the Office of Sustainable Fisheries.
        On May 28, 1999, NMFS published in the Federal Register (64 FR 29090) final regulations, effective July 1, 1999, implementing the HMS FMP. The HMS FMP and its implementing regulations establish percentage quota shares for the ICCAT-recommended U.S. BFT landing quota for each of the domestic fishing categories, and include measures regarding geographic subquotas and set-asides.
        Angling Category Geographical Division
        In response to quota reductions in 1992, two management areas were created for the BFT Angling category fishery. The north-south division line is located at 38°47' N. latitude (Delaware Bay). Generally, the recreational fishery begins each season off the southern and mid-Atlantic states, and so a subdivision was created to ensure a late season fishery in the northern mid-Atlantic and southern New England regions. Thus, the geographic split was designed to enable NMFS to manage the early season (June/July off the Virginia to Delaware coasts) and late season (August/September off the New Jersey to Massachusetts coasts) BFT fisheries under separate quotas, corresponding with the summer feeding migration of school, large school, and small medium BFT.
        For the last several BFT fishing seasons, NMFS has received comments that an adjustment to the Angling category BFT north-south division line is warranted. Specifically, vessels fishing for BFT from ports in southern New Jersey, which is in the northern area, tend to utilize fishing areas located in the southern area (i.e., offshore of Ocean City, Maryland). This pattern of activity raises two concerns with respect to the dividing line for the southern and northern areas. First, when the southern and northern areas are both open, a significant number of fish caught in the southern area are landed in the northern area and counted against the applicable northern area subquotas. Second, when the southern area is closed, vessels from southern New Jersey are effectively excluded from the school BFT fishery because the fish are generally distributed too far north to accommodate single-day trips. NMFS has received specific suggestions to move the north-south division line to the north of the Ocean City, New Jersey area or to the south of the Ocean City, Maryland area.

        NMFS is requesting comments on whether the current north-south division line is adequate or whether it should be moved to increase the geographical extent of recreational fishing opportunities and to define the northern and southern areas in a manner consistent with current fishing patterns. Any change to the current division line and subsequent reallocation of quota, must be consistent with the HMS FMP, specifically with the objectives to better coordinate domestic conservation and management of the fisheries and to simplify and streamline HMS management. For the BFT Angling category, it is NMFS' goal to ensure reasonable fishing opportunities in all geographic areas without risking overharvest of the Angling category quota.
        Various options include: (1) No adjustment to the division line; (2) move the division line to the Ocean City, New Jersey area or to 39°18' N. latitude, just north of Great Egg Inlet to effectively isolate the fisheries as virtually all vessels fishing for BFT from these areas fish in the southern, early season fishery (as suggested to NMFS in previous public comments); (3) move the division line to 38° 03' N. latitude (south of Ocean City, Maryland), so that all of the fishing activity based out of Maryland, Delaware, and southern New Jersey ports takes place in one area, i.e., a newly defined northern area (as suggested to NMFS in previous public comments); (4) move the division line to another latitude that is also consistent with the HMS management objectives mentioned above; and (5) eliminate the line altogether and use NMFS' existing authority to close and open the fishery based on inseason monitoring through review of daily landing trends, availability of BFT on the fishing grounds, and any other relevant factors, to provide for maximum utilization of the quota over the longest possible period of time. Adjusting the location of the north-south division line may reduce confusion and may prevent vessels from being excluded from participating in the fishery, especially when retention limits are different in the two areas.
        Angling Category BFT Subquotas
        Currently, there are separate Angling category BFT quota landings allocations for each of the areas north and south of the division line (38°47' N. lat). As stated in the HMS FMP, allocations to the southern area are as follows: (1) 47.2 percent of the school BFT Angling category landings quota, minus the school BFT quota held in reserve; (2) 47.2 percent of the large school/small medium BFT Angling category quota; and (3) 66.7 percent of the large medium and giant BFT Angling category quota. Allocations to the northern area are as follows: (1) 52.8 percent of the school BFT Angling category landings quota, minus the school BFT quota held in reserve; (2) 52.8 percent of the large school/small medium BFT Angling category quota; and (3) 33.3 percent of the large medium and giant BFT Angling category quota.
        If NMFS adjusts the north-south division line, revision of the north and south allocation percentages also may be considered. Various options for revising the north and south allocation percentages include: (1) Maintain the status quo, i.e., no quota allocation change; (2) revise the allocation based on a review of data regarding estimated landings of all sizes of BFT north and south of any new division line; or (3) switch the north-south allocation percentages of school through small medium BFT in conjunction with implementation of an Ocean City, New Jersey area division line, i.e., 52.8 percent for the southern area and 47.2 for the northern area (as suggested to NMFS in previous public comments).
        Request for Comments
        NMFS requests comments on whether the location of the north-south division line in the Angling category should be adjusted and, if so, to where; and whether the subquota allocations for the northern and southern areas should be adjusted and, if so, how. Comments received on this ANPR will assist NMFS in drafting any future proposed changes to the Atlantic HMS regulations. The public will be provided ample opportunity for written and verbal comments following publication of any proposed regulatory amendments concerning these issues.

          Authority:
          16 U.S.C. 971 et
            seq. and 1801 et
            seq.

          Dated: April 4, 2000.
          Bruce C. Morehead,
          Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.

      [FR Doc. 00-8773 Filed 4-7-00; 8:45 am]
      BILLING CODE 3510-22-F


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 679
        RIN 0648-AW06
        Fisheries of the Exclusive Economic Zone Off Alaska; Groundfish Fisheries of the Bering Sea and Aleutian Islands Management Area

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

          ACTION:
          Availability of an amendment to a fishery management plan; request for comments.

          SUMMARY:

          The North Pacific Fishery Management Council has submitted Amendment 89 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) to establish Bering Sea habitat conservation measures. This amendment, if approved, would prohibit nonpelagic trawling in certain waters of the Bering Sea subarea to protect bottom habitat from the potential adverse effects of nonpelagic trawling. This amendment also would establish the Northern Bering Sea Research Area for studying the impacts of nonpelagic trawling on bottom habitat. This action is necessary to protect portions of the Bering Sea subarea bottom habitat from the potential adverse effects of nonpelagic trawling. This action is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the FMP, and other applicable laws. Comments from the public are welcome.

          DATES:
          Written comments on the amendment must be received by 1700 hours, A.l.t. on April 28, 2008.

          ADDRESSES:
          Send comments to Sue Salveson, Assistant Regional Administrator, Sustainable Fisheries Division, Alaska Region, NMFS, Attn: Ellen Sebastian. You may submit comments, identified by 0648-AW06, by any one of the following methods:

          • Electronic Submissions: Submit all electronic public comments via the Federal eRulemaking Portal http://www.regulations.gov.
          • Mail: P.O. Box 21668, Juneau, AK 99802.
          • Hand delivery: 709 West 9th Street, Room 420A, Juneau, AK.
          • Fax: 907-586-7557.

          All comments received are a part of the public record and will generally be posted to http://www.regulations.gov without change. All Personal Identifying Information (e.g., name, address) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information.
          NMFS will accept anonymous comments. Attachments to electronic comments will be accepted in Microsoft Word, Excel, WordPerfect, or Adobe portable document file (pdf) formats only.

          Copies of the FMP amendment, maps of the Bering Sea subarea nonpelagic trawl closure areas and Northern Bering Sea Research Area, and the Environmental Assessment/Regulatory Impact Review/Initial Regulatory Flexibility Analysis (EA/RIR/IRFA) for this action may be obtained from the Alaska Region NMFS address above or from the Alaska Region NMFS website at http://www.fakr.noaa.gov.

          FOR FURTHER INFORMATION CONTACT:
          Melanie Brown, 907-586-7228 or melanie.brown@noaa.gov.

        SUPPLEMENTARY INFORMATION:

        The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) requires that the North Pacific Fishery Management Council (Council) submit any FMP amendment it prepares to NMFS for review and approval, disapproval, or partial approval. The Magnuson-Stevens Act also requires that NMFS, upon receiving an FMP amendment, immediately publish a notice in the Federal Register that the amendment is available for public review and comment.

        If approved by NMFS, this amendment would revise the FMP by establishing areas closed to nonpelagic trawling in the Bering Sea subarea. In June 2007, the Council recommended certain portions of the Bering Sea subarea be closed to nonpelagic trawling to prevent the potential adverse effects of nonpelagic trawling on portions of bottom habitat of the Bering Sea subarea. These closed areas would include locations that have not been previously fished with nonpelagic trawl gear, nearshore bottom habitat areas that may support subsistence marine resources, and a research area that could be used for studying the potential impacts of nonpelagic trawling on bottom habitat. Maps of the four areas that would be closed to nonpelagic trawling and the research area are available from the Alaska Region NMFS website at http://www.fakr.noaa.gov/habitat/efh.htm. Each proposed closed area and the research area are described below.
        Bering Sea Habitat Conservation Area
        The Council recommended preventing expansion of the nonpelagic trawl fisheries into portions of the Bering Sea subarea not previously fished with nonpelagic trawl gear by limiting nonpelagic trawling to locations historically fished with nonpelagic trawl gear. Areas not historically fished with nonpelagic trawl gear include portions of the Bering Sea subarea located in the deep water basin southwest of the continental slope and in the northern portion of the subarea. The portion of the Bering Sea subarea historically fished with nonpelagic trawl gear is on the continental slope northeast of the deep water basin, not including existing trawl closures (such as the Pribilof Island Area Habitat Conservation Zone and the Chum and Chinook Salmon Savings Areas) and south of Nunivak and St. Matthew Islands. Several closures that cover the entire northern portion of the Bering Sea subarea also were recommended by the Council for this proposed amendment and are further explained below.
        The Bering Sea Habitat Conservation Area (BSHCA) is designed to prevent expansion of the nonpelagic trawl fishery. The BSHCA would be located primarily in the deep waters of the Bering Sea subarea including statistical area 530 and portions of areas 518, 523, 533, and 531. The BSHCA would cover 46,776 square nautical miles (nm2).
        Nunivak Island, Etolin Strait, and Kuskokwim Bay Habitat Conservation Area
        The Council consulted with a working group of nonpelagic trawl fishing industry members and subsistence resources users to identify bottom habitat in the Bering Sea subarea that may support subsistence marine resources and to identify potential nonpelagic trawl fishery management measures. This group identified potential important bottom habitat in the Bering Sea subarea that may support subsistence marine resources and recommended locations to be closed to nonpelagic trawling. Based on this workgroup's recommendation, the Council recommended closing waters surrounding Nunivak Island, and within Etolin Strait and Kuskokwim Bay, to nonpelagic trawling. Amendment 89 would establish this area as the Nunivak Island, Etolin Strait, and Kuskokwim Bay Habitat Conservation Area. This habitat conservation area would cover 9,777 nm2.
        St. Lawrence Island Habitat Conservation Area and St. Matthew Islands Habitat Conservation Area
        The Council recommended closing waters near St. Matthew and St. Lawrence Islands to nonpelagic trawling for the protection of blue king crab habitat and to protect bottom habitat areas near St. Lawrence Island that may support subsistence marine resources. Amendment 89 would establish these areas as the St. Matthew Island Habitat Conservation Area and the St. Lawrence Island Habitat Conservation Area. These habitat conservation areas would cover 11,065 nm2.
        Northern Bering Sea Research Area

        The Council also recommended establishing the Northern Bering Sea Research Area (NBSRA) to provide an opportunity to further understand the potential effects of nonpelagic trawling on Bering Sea subarea bottom habitat. This area would contain waters with little or no nonpelagic trawling in the northern portion of the Bering Sea subarea, including portions of statistical areas 514 and 524, exclusive of the closure around St. Lawrence Island. This area would cover 65,859 nm2.
        The NBSRA would be closed to nonpelagic trawling to provide a control area to study the potential effects of nonpelagic trawling on bottom habitat. Nonpelagic trawling within the NBSRA would be allowed only within the scope of a nonpelagic trawling effects research plan. A research plan would be developed, in cooperation with the Alaska Fisheries Science Center, to address potential protection measures for species that may depend on bottom habitat, including king and snow crabs, marine mammals, and Endangered Species Act-listed species, and to address nearshore subsistence resources for Western Alaska communities. This research plan would be reviewed by the Council within 24 months after the publication of the final rule implementing Amendment 89. Nonpelagic trawling in the NBSRA would be limited to fishing under an exempted fishing permit that would be consistent with the nonpelagic trawling research plan approved by the Council.

        NMFS is soliciting public comments on the proposed amendment through April 28, 2008. A proposed rule that would implement the amendment will be published in the Federal Register for public comment at a later date, following NMFS' evaluation under the Magnuson-Stevens Act procedures. Public comments on the proposed rule must be received by the end of the comment period on the amendment in order to be considered in the approval/disapproval decision on the amendment. All comments received on the amendment by the end of the comment period, whether specifically directed to the amendment or to the proposed rule, will be considered in the approval/disapproval decision. Comments received after that date will not be considered in the approval/disapproval decision on the amendment. To be considered, comments must be received—not just postmarked or otherwise transmitted—by 1700 hours, A.l.t. on the last day of the comment period.

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

          Dated: February 20, 2008.
          Emily H. Menashes
          Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.

      [FR Doc. E8-3697 Filed 2-26-08; 8:45 am]
      BILLING CODE 3510-22-S


        DEPARTMENT OF THE INTERIOR
        Fish and Wildlife Service
        50 CFR Part 17
        RIN 1018-AH04

        Endangered and Threatened Wildlife and Plants; Reopening of Public Comment Period and Notice of Availability of Draft Economic Analysis for Proposed Critical Habitat Determination for Chorizanthe pungens var. pungens (Monterey Spineflower)

          AGENCY:
          Fish and Wildlife Service, Interior.

          ACTION:
          Proposed rule; reopening of public comment period and notice of availability of draft economic analysis.

          SUMMARY:

          We, the U.S. Fish and Wildlife Service (Service) announce the availability of a draft economic analysis for the proposed designation of critical habitat for the Monterey spineflower (Chorizanthe pungens var. pungens). We are also providing notice of the reopening of the public comment period for the proposal to designate critical habitat for this plant to allow all interested parties to comment simultaneously on the proposed rule and the associated draft economic analysis. Comments previously submitted need not be resubmitted as they already have been incorporated into the public record and will be fully considered in the final rule. Comments submitted during this comment period will also be incorporated into the public record and will be fully considered in the final rule.

          DATES:
          The comment period is opened and we will accept comments until October 19, 2001. Comments must be received by 5:00 p.m. on the closing date. Any comments that are received after the closing date may not be considered in the final decision on this proposal.

          ADDRESSES:

          Copies of the draft economic analysis are available on the Internet at “www.r1.fws.gov” or by writing to the Field Supervisor, U.S. Fish and Wildlife Service, Ventura Fish and Wildlife Office, 2493 Portola Road, Suite B, Ventura, California 93003. All written comments should be sent to the Field Supervisor at the above address. You may also send comments by electronic mail (e-mail) to “fw1montereysf@r1.fws.gov”. Please submit electronic comments in ASCII file format and avoid the use of special characters and encryption. Please include “Attn: RIN 1018-AH04” and your name and return address in your e-mail message. If you do not receive a confirmation from the system that we have received your e-mail message, contact us directly by calling our Ventura Fish and Wildlife Office at phone number 805-644-1766. Comments and materials received will be available for public inspection, by appointment, during normal business hours at the above Service address.

          FOR FURTHER INFORMATION CONTACT:
          Catrina Martin, Assistant Field Supervisor, Ventura Fish and Wildlife Office, at the above address (telephone 805-644-1766; facsimile 805-644-3958).

        SUPPLEMENTARY INFORMATION:
        Background

          Chorizanthe pungens var. pungens is endemic to sandy soils in coastal areas in southern Santa Cruz and northern Monterey counties, and in the Salinas Valley in interior Monterey County. In California, the spineflower genus (Chorizanthe) in the buckwheat family Polygonaceae comprises species of wiry annual herbs that inhabit dry sandy soils, both along the coast and inland. Because of the patchy and limited distribution of such soils, many species of Chorizanthe tend to be highly localized in their distributions.
        The overall appearance of Chorizanthe pungens var. pungens is of a low-growing herb that is soft-hairy and grayish or reddish in color. The plant has a prostrate to slightly ascending habit, with large individuals reaching 50 centimeters (cm) (20 inches (in)) or more in diameter. This taxon is distinguished by white (rarely pinkish) scarious (membranous) margins on the lobes of the involucre (a whorl of bracts) that subtend the white- to rose-colored flowers. The aggregate of flowers (heads) tend to be small (less than 1 cm (0.4 in) in diameter) and either distinctly or indistinctly aggregate.

          Chorizanthe pungens var. pungens is a short-lived annual species. It germinates during the winter months and flowers from April through June; although pollination ecology has not been studied for this taxon, C. p. var. pungens is likely visited by a wide array of pollinators; observations of pollinators on other species of Chorizanthe that occur in Santa Cruz County have included leaf cutter bees (megachilids), at least six species of butterflies, flies, and sphecid wasps (R. Morgan, biologist, Soquel, CA, pers. comm. 2000). Each flower produces one seed; depending on the vigor of an individual plant, dozens, if not hundreds of seeds could be produced. The importance of pollinator activity in seed set has been demonstrated by the production of seed with low viability where pollinator access was limited (Harding Lawson Associates 2000). Seed is collectable through August. The plants turn a rusty hue as they dry through the summer months, eventually shattering during the fall. Seed dispersal is facilitated by the spines on the involucre, which attach the seed to passing animals. While animal vectors most likely facilitate dispersal between colonies and populations, the prevailing coastal winds undoubtedly play a part in scattering seed within colonies and populations.
        The locations where Chorizanthe pungens var. pungens occurs, with the exception of one (Soledad), are subject to a mild maritime climate, where fog helps keep summer temperatures cool and winter temperatures relatively warm, and provides moisture in addition to the normal winter rains. Chorizanthe pungens var. pungens is found in a variety of seemingly disparate habitat types, including active coastal dunes, grassland, scrub, chaparral, and woodland types on interior upland sites; and interior floodplain dunes. However, all of these habitat types include microhabitat characteristics that are suitable for C. p. var. pungens. First, all sites are on sandy soils; whether the origin of the soils are from active dunes, interior fossil dunes, or floodplain alluvium is apparently unimportant. Second, these sites are relatively open and free of other vegetation. In grassland and oak woodland communities, abundant annual grasses may outcompete C. p. var. pungens, while management of grass species, either through grazing, mowing or fire, may allow the spineflower to persist. In scrub and chaparral communities, C. p. var. pungens does not occur under dense stands, but will occur between more widely spaced shrubs.

          Chorizanthe pungens var. pungens is generally distributed along the rim of Monterey Bay in southern Santa Cruz and northern Monterey counties, and inland along the coastal plain of the Salinas Valley. At coastal sites ranging from the Monterey Peninsula north to Manresa State Beach, C. p. var. pungens is found in active coastal dune systems, and on coastal bluffs upon which windblown sand has been deposited. On coastal dunes, the distribution of suitable habitat is subject to dynamic shifts caused by patterns of dune mobilization, stabilization, and successional trends in coastal dune scrub that increase in cover over time. Accordingly, individual colonies of Chorizanthe pungens var. pungens, found in gaps between stands of scrub, shift in distribution and size over time.

        Portions of the coastal dune and coastal scrub communities that support Chorizanthe pungens var. pungens have been eliminated or altered by recreational use, industrial and urban development, and military activities. Dune communities have also been altered in composition by the introduction of non-native species, especially Carpobrotus species (sea-fig or iceplant) and Ammophila arenaria (European beachgrass), in an attempt to stabilize shifting sands. In the last decade, significant efforts have been made to restore native dune communities, including the elimination of these non-native species.
        At more inland sites, Chorizanthe pungens var. pungens occurs on sandy, well-drained soils in a variety of plant communities, most frequently maritime chaparral, valley oak woodlands, and grasslands. The plant probably has been extirpated from a number of historical locations in the Salinas Valley, primarily due to conversion of the original grasslands and valley oak woodlands to agricultural crops (Reveal & Hardham 1989). Significant populations of C. p. var. pungens occur on lands that are referred to as former Fort Ord (U.S. Army Corps of Engineers 1992). Within grassland communities, C. p. var. pungens occurs along roadsides, in firebreaks, and in other disturbed sites, while in oak woodland, chaparral, and scrub communities, it occurs in sandy openings between shrubs. In older stands with a high cover of shrubs, the plants are restricted to roadsides, firebreaks, and trails that bisect these communities. At former Fort Ord, the highest densities of C. p. var. pungens are located in the central portion of the firing range, where disturbance is the most frequent. This pattern of distribution and densities of the C. p. var. pungens on former Fort Ord indicates that the very activities that have disturbed C. p. var. pungens habitat have also created the open conditions that result in high densities of the plant. Prior to onset of human use of this area, C. p. var. pungens may have been restricted to openings created by wildfires within these communities (Service 1998).
        The southwestern edge of Chorizanthe pungens var. pungens habitat on former Fort Ord was once continuous with habitat found in the community of Del Rey Oaks and at the Monterey Airport (Deb Hillyard, ecologist, California Department of Fish and Game, pers. comm. 2000). Other inland sites that support C. p. var.
          pungens are located in the area between Aptos and La Selva Beach in Santa Cruz County, and near Prunedale in northern Monterey County.
        Farther up the Salinas River, Chorizanthe pungens var. pungens was recently found on a dune located within the river floodplain near Soledad, Monterey County (CNDDB 2000). Two historic sites for C. p. var. pungens occur near here. One, near Mission Soledad, was collected once in 1881; the other, near San Lucas along the Salinas River, was collected once in 1935. Due to conversion to agriculture and channelization activities along the Salinas River over the last century, C. p. var. pungens has most likely been extirpated from these locations. The dune near Soledad is the only one of its size and extent between there and the river mouth (Brad Olsen, East Bay Regional Parks District, pers. comm. 2000).

        Pursuant to the Endangered Species Act of 1973, as amended (Act), Chorizanthe pungens var. pungens was federally listed as threatened on February 4, 1994 (59 FR 5499). On February 15, 2001, we published in the Federal Register (66 FR 10440) a rule proposing critical habitat for the C. p. var. pungens. Approximately 10,400 hectares (25,000 acres) fall within the boundaries of the proposed critical habitat designation. Proposed critical habitat is located in Santa Cruz and Monterey counties, as described in the proposed rule.
        Section 4(b)(2) of the Act requires that the Secretary shall designate or revise critical habitat based upon the best scientific and commercial data available and after taking into consideration the economic impact of specifying any particular area as critical habitat. Based upon the previously published proposal to designate critical habitat for the Monterey spineflower and comments received during the previous comment period, we have prepared a draft economic analysis of the proposed critical habitat designation. The draft economic analysis is available at the above Internet and mailing address.
        Public Comments Solicited

        We have reopened the comment period at this time in order to accept the best and most current scientific and commercial data available regarding the proposed critical habitat determination for the Monterey spineflower and the draft economic analysis of proposed critical habitat determination. Previously submitted written comments on this critical habitat proposal need not be resubmitted. We will accept written comments during this reopened comment period. The current comment period on this proposal closes on October 4, 2001. Written comments may be submitted to the Ventura Fish and Wildlife Office in the ADDRESSES section.
        Author

        The primary author of this notice is Connie Rutherford, U.S. Fish and Wildlife Service, 2493 Portola Road, Suite B, Ventura, California 93003 (see ADDRESSES section).

          Authority:

          The authority for this action is the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.).

          Dated: September 7, 2001.
          Daniel S. Walsworth,
          Acting Manager, California/Nevada Operations Office.

      [FR Doc. 01-23248 Filed 9-18-01; 8:45 am]
      BILLING CODE 4310-55-P


        DEPARTMENT OF DEFENSE
        Defense Acquisition Regulations System
        48 CFR Parts 201, 209, 211, and 252
        [Docket DARS-2018-0059]
        RIN 0750-AJ85
        Defense Federal Acquisition Regulation Supplement: Applicability of Inflation Adjustment of Acquisition Related Thresholds (DFARS Case 2018-D023)

          AGENCY:
          Defense Acquisition Regulations System, Department of Defense (DoD).

          ACTION:
          Proposed rule.

          SUMMARY:
          DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2018 to require that inflation adjustments of statutory acquisition-related thresholds apply to existing contracts and subcontracts in effect on the date of the adjustment that contain the adjusted clauses.

          DATES:
          Comments on the proposed rule should be submitted in writing to the address shown below on or before February 19, 2019, to be considered in the formation of a final rule.

          ADDRESSES:
          Submit comments identified by DFARS Case 2018-D023, using any of the following methods:
          ○ Federal eRulemaking Portal: http://www.regulations.gov. Search for “DFARS Case 2018-D023.” Select “Comment Now” and follow the instructions provided to submit a comment. Please include “DFARS Case 2018-D023” on any attached documents.
          ○ Email: osd.dfars@mail.mil. Include DFARS Case 2018-D023 in the subject line of the message.
          ○ Fax: 571-372-6094.
          ○ Mail: Defense Acquisition Regulations System, Attn: Ms. Heather Kitchens, OUSD(A&S)DPC/DARS, Room 3B941, 3060 Defense Pentagon, Washington, DC 20301-3060.

          Comments received generally will be posted without change to http://www.regulations.gov, including any personal information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

          FOR FURTHER INFORMATION CONTACT:
          Ms. Heather Kitchens, telephone 571-372-6104.

        SUPPLEMENTARY INFORMATION:
        I. Background
        This rule proposes to revise the DFARS to implement section 821 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2018 (Pub. L. 115-91). Section 821 amends 41 U.S.C. 1908(d) to require that the inflation adjustments of statutory acquisition-related thresholds under 41 U.S.C. 1908 apply to existing contracts and subcontracts in effect on the date of the adjustment.

        41 U.S.C. 1908, Inflation adjustment of acquisition-related dollar thresholds, requires an adjustment every five years of statutory acquisition-related thresholds for inflation using the Consumer Price Index for All Urban Consumers (CPI-U), except for the Construction Wage Rate Requirements statute (formerly known as the Davis-Bacon Act), Service Contract Labor Standards statute (formerly known as the Service Contract Act), and trade agreements thresholds. See Federal Acquisition Regulation (FAR) 1.109. The last DFARS case that raised the thresholds for inflation was 2014-D025, a final rule published in the Federal Register (80 FR 36903) on June 26, 2015, effective October 1, 2015. The next final rule to be published raising thresholds for inflation under 41 U.S.C. 1908 will be effective October 1, 2020.

        Section 821 adds the words “and shall apply, in the case of the procurement of property or services by contract, to a contract, and any subcontract at any tier under the contract, in effect on that date without regard to the date of award of the contract or subcontract” at the end of 41 U.S.C. 1908(d). Therefore, if acquisition-related thresholds are adjusted under 41 U.S.C. 1908 during the life of a contract, then that contract and all of the subcontracts under that contract will now be subject to the adjusted thresholds.
        II. Discussion and Analysis
        Currently, the DFARS clauses that contain thresholds subject to inflation adjustment provide the specific dollar amount of the threshold. To implement the new requirements under 41 U.S.C. 1908(d), DoD is proposing to replace the dollar amounts of the thresholds in each clause with a reference to the FAR or DFARS section that provides the overarching policy and the acquisition-related threshold. If the DFARS policy section does not currently include the acquisition-related threshold, this rule proposes amendments to those sections to add the thresholds. In addition, within the affected DFARS clauses, additional text is added to clarify that the threshold with which a contractor or subcontractor must comply is the threshold in effect at the time of contract or subcontract award or issuance of the notice, as appropriate.
        These changes not only reduce the number of places to update the thresholds for future inflation changes, but also ensures that future contracts containing these clauses always include a reference to the current threshold. The following is a summary of the DFARS clauses affected by this rule and the associated FAR or DFARS policy sections that include or will include the acquisition-related threshold as a result of this rule or the related FAR rule:

            DFARS clause
            FAR/DFARS policy section
            Threshold

            252.203-7004, Display of Hotline Posters
            DFARS 203.1004(b)(2)(ii)
            Currently includes threshold.

            252.209-7004, Subcontracting with Firms That Are Owned or Controlled by the Government of a Country that is a State Sponsor of Terrorism
            FAR 9.405-2(b)
            Currently includes threshold.

            252.209-7009, Organizational Conflict of Interest—Major Defense Acquisition Program
            DFARS 209.571-1
            Threshold to be added under this rule.

            252.219-7003, Small Business Subcontracting Plan (DoD Contracts)
            FAR 19.702(a)
            Currently includes threshold.

            252.219-7004, Small Business Subcontracting Plan (Test Program)
            FAR 19.702(a)
            Currently includes threshold.

            252.225-7004, Report of Intended Performance Outside the United States and Canada—Submission after Award
            DFARS 225.870-4(c)(2)(i)(A)(1)
            Currently includes threshold.

            252.249-7002, Notification of Anticipated Contract Termination or Reduction
            DFARS 225.870-4(c)(2)(i)(A)(1) and 225.870-4(c)(2)(i)(C)
            Currently includes threshold.

        In order to incorporate the acquisition-related threshold in the DFARS policy section associated with DFARS clause 252.209-7009 and to be consistent with current drafting conventions, the definitions in DFARS 209.571-1 are proposed to be provided in full text, in lieu of referring to the definitions in clauses. The statutory acquisition-related threshold in DFARS clause 252.211-7000 is proposed to be incorporated in a new DFARS policy section 211.7000.
        Finally, this rule proposes to add a new paragraph at 201.109(a) to advise contracting officers of the new requirements of 41 U.S.C. 1908(d) with regard to the effective date of statutory acquisition-related thresholds that are subject to adjustment based on inflation.
        III. Applicability to Contracts at or Below the Simplified Acquisition Threshold and for Commercial Items, Including Commercially Available Off-the-Shelf Items
        This rule does not propose to create any new provisions or clauses or impact any existing provisions or clauses, except for moving dollar values of thresholds in the stated clauses and adding references in these clauses to the location of the threshold in the associated DFARS policy section. Therefore, there is no change to the applicability of any of the clauses to contracts at or below the simplified acquisition threshold, or to the acquisition of commercial items, including commercially available off-the-shelf items.
        IV. Executive Orders 12866 and 13563
        Executive Order (E.O.s) 12866, Regulatory Planning and Review; and E.O. 13563, Improving Regulation and Regulatory Review, direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This is not a major rule under 5 U.S.C. 804.
        V. Executive Order 13771
        This rule is not an E.O. 13771 regulatory action, because this rule is not significant under E.O. 12866.
        VI. Regulatory Flexibility Act

        DoD does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. The scope of the rule relates to amending the Defense Federal Acquisition Regulation Supplement (DFARS) to require that inflation adjustments of statutory acquisition-related thresholds under 41 U.S.C. 1908 apply to existing contracts and subcontracts in effect on the date of the adjustment. However, an initial regulatory flexibility analysis has been performed and is summarized as follows:
        DoD is proposing to amend the DFARS to make inflation adjustments of statutory acquisition-related thresholds under 41 U.S.C. 1908(d) applicable to existing contracts and subcontracts in effect on the date of the adjustment that contain the revised clauses.

        The objective is to implement section 821 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2018. Section 821 amends 41 U.S.C. 1908(d) to require inflation adjustments of statutory acquisition-related thresholds under 41 U.S.C. 1908 apply to existing contracts and subcontracts in effect on the date of the adjustment. Section 821 adds the words “and shall apply, in the case of the procurement of property or services by contract, to a contract, and any subcontract at any tier under the contract, in effect on that date without regard to the date of award of the contract or subcontract” at the end of 41 U.S.C. 1908(d).
        This proposed rule will likely affect to some extent all small business concerns that submit offers or are awarded contracts by the Federal Government.
        However, this rule is not expected to have any significant economic impact on small business concerns because this rule is only establishing the framework to apply the inflation adjustments of statutory acquisition-related thresholds under 41 U.S.C. 1908 to existing contracts and subcontracts in effect on the date of the adjustment. Any impact on small business concerns will be beneficial by preventing burdensome requirements from applying to the smaller dollar value acquisitions, which are the acquisitions in which small business concerns are most likely to participate.
        For FY 2017, there were 106,438 unique vendors in the Federal Procurement Data System (FPDS) identified as small business concerns.

        As of September 30, 2017, there were 637,791 active entity registrations in SAM.gov. Of those active entity registrations, 452,310 (71%) completed all four modules of the registration, in accordance with Federal Acquisition Regulation 52.204-7(a)(2), including Assertions (where they enter their size metrics and select their North American Industry Classification System (NAICS) Codes) and Representations and Certifications (where they certify to the information they provided and the size indicator by NAICS).
        Of the possible 452,310 active SAM.gov entity registrations, 338,207 (75%) certified to meeting the size standard of small for their primary NAICS Code. Therefore, this rule may be beneficial to 338,207 small business entities that submit proposals that may now fall under the micro-purchase threshold and the simplified acquisition threshold, which provide for the use of streamlined procedures.
        This proposed rule does not include any new reporting or recordkeeping requirements for small entities.
        The rule does not duplicate, overlap, or conflict with any other Federal rules.
        There are no known significant alternative approaches to the proposed rule that would meet the requirements of the applicable statute.
        DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
        DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2018-D023), in correspondence.
        VII. Paperwork Reduction Act
        The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

          List of Subjects in 48 CFR Parts 201, 209, 211, and 252
          Government procurement.

          Jennifer Lee Hawes,
          Regulatory Control Officer, Defense Acquisition Regulations System.

        Therefore, 48 CFR parts 201, 209, 211, and 252 are proposed to be amended as follows:
        1. The authority citation for parts 201, 209, 211, and 252 continues to read as follows:

          Authority:
           41 U.S.C. 1303 and 48 CFR chapter 1.

          PART 201—FEDERAL ACQUISITION REGULATIONS SYSTEM

        2. Amend section 201.109 by—
        a. Designating the paragraph (a) text as paragraph (a)(ii); and
        b. Adding paragraph (a)(i).
        The addition reads as follows:

          201.109
           Statutory acquisition-related dollar thresholds-adjustment for inflation.
          (a)(i) 41 U.S.C. 1908(d) requires the adjustment for inflation of all statutory acquisition-related dollar thresholds in the DFARS be applied to contracts and subcontracts without regard to the date of award of the contract or subcontract, except thresholds based on the Wage Rate Requirements statute, the Service Contract Labor Standards statute, or established by the United States Trade Representative pursuant to the Trade Agreement Act, which are not escalated by the statute.

          PART 209—CONTRACTOR QUALIFICATION

        3. Amend section 209.571-1 by revising the definitions of “Lead system integrator” and “Major subcontractor” to read as follows:

          209.571-1
          Definitions.

          “Lead system integrator” includes lead system integrator with system responsibility and lead system integrator without system responsibility.

          (1) Lead system integrator with system responsibility means a prime contractor for the development or production of a major system, if the prime contractor is not expected at the time of award to perform a substantial portion of the work on the system and the major subsystems.
          (2) Lead system integrator without system responsibility means a prime contractor under a contract for the procurement of services, the primary purpose of which is to perform acquisition functions closely associated with inherently governmental functions (see section 7.503(d) of the Federal Acquisition Regulation) with respect to the development or production of a major system. “Major subcontractor” means a subcontractor that is awarded a subcontract that equals or exceeds—
          (1) Both the certified cost or pricing data threshold and 10 percent of the value of the contract under which the subcontract is awarded; or
          (2) $55 million.

          PART 211—DESCRIBING AGENCY NEEDS

        4. Add section 211.7000 to read as follows:

          211.7000
           Acquisition streamlining.
          Acquisition streamlining is required for all systems acquisition program contracts and for all subcontracts over $1.5 million awarded in the performance of contracts for systems acquisition programs.

          PART 252—SOLICITATION PROVISIONS AND CONTRACT CLAUSES

        5. Amend section 252.203-7004 by—
        a. Removing the clause date of “(OCT 2016)” and adding “(DATE)” in its place;
        b. Revising paragraph (d).
        The revision reads as follows:

          252.203-7004
           Display of Hotline Posters.

          (d) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (d), in all subcontracts that exceed the threshold specified in Defense Federal Acquisition Regulation Supplement 203.1004(b)(2)(ii) on the date of subcontract award except when the subcontract is for the acquisition of a commercial item.

          252.209-7004
           [Amended]

        6. Amend section 252.209-7004 by—

        a. Removing the clause date of “(OCT 2015)” and adding “(DATE)” in its place;

        b. In paragraph (a), removing “$35,000” and adding “the threshold specified in Federal Acquisition Regulation 9.405-2(b) on the date of subcontract award” in its place.
        7. Amend section 252.209-7009 by—
        a. Removing the clause date of “(OCT 2015)” and adding “(DATE)” in its place; and
        b. Revising paragraph (a).
        The revision reads as follows:

          252.209-7009
          Organizational Conflict of Interest—Major Defense Acquisition Program.

          (a) Definition. As used in this clause—

            Major subcontractor means a subcontractor that is awarded a subcontract that equals or exceeds—
          (1) Both the certified cost or pricing data threshold and 10 percent of the value of the contract under which the subcontract is awarded; or
          (2) The threshold specified in the definition of “major subcontractor” at Defense Federal Acquisition Regulation Supplement 209.571-1 on the date of subcontract award.

        8. Amend section 252.219-7003 by—
        a. Removing the clause date of “(APR 2018)” and adding “(DATE)” in its place;
        b. Revising paragraph (g);
        c. In Alternate I—
        i. Removing the clause date of “(APR 2018)” and adding “(DATE)” in its place; and
        b. Revising paragraph (g).
        The revision reads as follows:

          252.219-7003
           Small Business Subcontracting Plan (DoD Contracts)

          (g) Include the clause at Defense Federal Acquisition Regulation Supplement (DFARS) 252.219-7004, Small Business Subcontracting Plan (Test Program), in subcontracts with subcontractors that participate in the Test Program described in DFARS 219.702-70, if the subcontract is expected to exceed the applicable threshold specified in Federal Acquisition Regulation 19.702(a), and to have further subcontracting opportunities.

            Alternate I. * * *
          (g) Include the clause at Defense Federal Acquisition Regulation Supplement (DFARS) 252.219-7004, Small Business Subcontracting Plan (Test Program), in subcontracts with subcontractors that participate in the Test Program described in DFARS 219.702-70, if the subcontract is expected to exceed the applicable threshold specified in Federal Acquisition Regulation 19.702(a), and to have further subcontracting opportunities.

        9. Amend section 252.219-7004 by—
        a. Revising the section heading;
        b. Removing the clause date of “(APR 2018)” and adding “(DATE)” in its place;
        c. Revising paragraph (g) introductory text.
        d. In paragraph (g)(1), removing “252.219-7003” and adding “Defense Federal Acquisition Regulation Supplement (DFARS) 252.219-7003” in its place;
        e. In paragraph (g)(2), removing “252.219-7003” and adding “DFARS 252.219-7003” in its place; and
        f. In paragraph (g)(3), removing “252.219-7004” and adding “DFARS 252.219-7004” in its place.
        The revisions read as follows:

          252.219-7004
           Small Business Subcontracting Plan (Test Program).

          (g) Subcontracts. The Contractor shall include in subcontracts that offer subcontracting opportunities, are expected to exceed the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, and are required to include the clause at FAR 52.219-8, Utilization of Small Business Concerns, the clauses at—

        10. Amend section 252.225-7004 by—
        a. Removing the clause date of “(OCT 2015)” and adding “(DATE)” in its place; and
        b. Revising paragraphs (a) and (b)(1).
        The revisions read as follows:

          252.225-7004
           Report of Intended Performance Outside the United States and Canada—Submission after Award.

          (a) Definition. As used in this clause—

            United States means the 50 States, the District of Columbia, and outlying areas.
          (b) * * *

          (1) Exceeds the threshold specified in Defense Federal Acquisition Regulation Supplement 225.870-4(c)(2)(i)(A)(1) on the date of award of this contract; and

        11. Amend section 252.249-7002 by—
        a. Revising the section heading;
        b. Removing the clause date of “(OCT 2015)” and adding “(DATE)” in its place;
        c. Adding paragraph (a) introductory text; and
        d. Revising paragraphs (d)(1) and (2).
        The addition and revisions read as follows:

          252.249-7002
           Notification of Anticipated Contract Termination or Reduction.

          (a) * * * As used in this clause—

          (d) * * *

          (1) Provide notice of the anticipated termination or reduction to each first-tier subcontractor with a subcontract that equals or exceeds the threshold specified in Defense Federal Acquisition Regulation Supplement (DFARS) 225.870-4(c)(2)(i)(A)(1) at the time of the notice; and
          (2) Require that each such subcontractor—
          (i) Provide notice to each of its subcontractors with a subcontract that equals or exceeds the threshold specified in DFARS 225.870-4(c)(2)(i)(C) at the time of the notice; and
          (ii) Impose a similar notice and flowdown requirement to subcontractors with subcontracts that equal or exceed the threshold specified in DFARS 225.870-4(c)(2)(i)(C) at the time of the notice.

      [FR Doc. 2018-27559 Filed 12-20-18; 8:45 am]
       BILLING CODE 5001-06-P


        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        Food and Drug Administration
        21 CFR Parts 347 and 352
        [Docket No. 1978N-0038] (formerly 78N-0038)
        RIN 0910-AF43
        Sunscreen Drug Products for Over-The-Counter Human Use; Proposed Amendment of Final Monograph; Extension of Comment Period

          AGENCY:
          Food and Drug Administration, HHS.

          ACTION:
          Proposed rule; extension of comment period.

          SUMMARY:
          The Food and Drug Administration (FDA) is extending to December 26, 2007, the comment period for the August 27, 2007, proposed rule to amend the final monograph for over-the-counter (OTC) sunscreen drug products (72 FR 49070).  The comment period for the proposed rule was to end on November 26, 2007.  The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

          DATES:
          Submit written or electronic comments by December 26, 2007.

          ADDRESSES:

          You may submit comments, identified by Docket No. 1978N-0038 and RIN number 0910-AF43, by any of the following methods:

        Electronic Submissions
        Submit electronic comments in the following ways:
        • Federal eRulemaking Portal: http://www.regulations.gov.  Follow the instructions for submitting comments.
        • Agency Web site: http://www.fda.gov/dockets/ecomments.  Follow the instructions for submitting comments on the agency Web site.
        Written Submissions
        Submit written submissions in the following ways:
        • FAX:   301-827-6870.
        • Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions):   Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

        To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail.  FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described in the Electronic Submissions portion of this paragraph.

          Instructions:   All submissions received must include the agency name, docket number and regulatory information number (RIN) for this rulemaking.  All comments received may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided.  For additional information on submitting comments, see the “Request for Comments” heading of the SUPPLEMENTARY INFORMATION section of this document.

          Docket:   For access to the docket to read background documents or comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 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:
          Matthew R. Holman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5414, Silver Spring, MD 20993, 301-796-2090.

        SUPPLEMENTARY INFORMATION:
        I.  Discussion
        In the Federal Register of May 21, 1999 (64 FR 27666), FDA published the final monograph for OTC sunscreen drug products in part 352 (21 CFR part 352) with an effective date of May 21, 2001.  Issues concerning active ingredients, labeling, and test methods for products intended to provide ultraviolet A (UVA) protection were deferred for future regulatory action because more time was required to review comments from interested parties.  In the Federal Register of June 8, 2000 (65 FR 36319), FDA reopened the administrative record of the rulemaking for OTC sunscreen drug products to allow for specific comment on high sun protection factor (SPF) and UVA radiation testing and labeling issues.  FDA also extended the effective date for the final monograph to December 31, 2002.
        In the Federal Register of December 31, 2001 (66 FR 67485), FDA stayed the December 31, 2002, effective date of the final monograph for OTC sunscreen drug products in part 352 pending further notice from FDA in a future issue of the Federal Register.  FDA took this action because we planned to amend part 352 to address formulation, labeling, and testing requirements for both ultraviolet B (UVB) and UVA radiation protection.  The existing stay of the effective date for part 352 remains in effect at this time.
        In the Federal Register of August 27, 2007 (72 FR 49070), FDA issued a proposed rule that would amend the final monograph for OTC sunscreen drug products to address both UVB and UVA testing and labeling requirements for sunscreen and sunscreen-skin protectant combination drug products.  FDA requested comments on the proposed amendments.  FDA also requested comments on issues related to OTC sunscreen drug products containing alpha hydroxy acids or titanium dioxide and zinc oxide formulated in particle sizes as small as a few nanometers.  The comment period on the proposed rule was scheduled to end on November 26, 2007.
        II.  Extension of the Comment Period
        The agency has received requests for an extension of the comment period for the proposed rule.  Each request conveyed concern that the current 90-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule.
        FDA has considered the requests and is extending the comment period for the proposed rule for 30 days, until December 26, 2007.  The agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues.
        In response to several requests to extend the comment period,  we are extending the comment period for 30 days, until December 26, 2007.
        III. Request for Comments

        Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on this document.  Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.  Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

        Please note that in January 2008, the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS).  FDMS is a Government-wide, electronic docket management system.  After the transition date, electronic submissions will be accepted by us through the FDMS only.  When the exact date of the transition to FDMS is known, we will publish a Federal Register notice announcing that date.
        IV.  References

        The following references are on display in the Division of Dockets Management (see ADDRESSES) under Docket No. 1978N-0038 and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.
        1.  Comment No. EXT10.
        2.  Comment No. EXT11.
        3.  Comment No. EXT12.
        4.  Comment No. EXT13.
        5.  Comment No. EXT14.
        6.  Comment No. EXT15.
        7.  Comment No. EXT16.
        8.  Comment No. EXT17.
        9.  Comment No. EXT18.

          Dated: November 21, 2007.
          Randall W. Lutter,
          Deputy Commissioner for Policy.

      [FR Doc. 07-5853 Filed 11-26-07; 9:25 am]
      BILLING CODE 4160-01-S