Title: Almonds Grown in California, Marketing Order No. 981.

OMB Number: 0581-0242.

Expiration Date of Approval: March 31, 2010.

Type of Request: Extension and revision of a currently approved information collection.

Abstract: The information collection requirements in this request are essential to carry out the intent of the Agricultural Marketing Agreement Act of 1937 (Act), as amended (7 U.S.C. 601-674), to provide the respondents the type of service they request, and to administer the California almond marketing order program (order) (7 CFR part 981) which has been operating since 1950.

The order and its rules and regulations authorize the Almond Board of California (board), the agency responsible for local administration of the order, to require handlers and other certain entities to submit information.

In September 2007, a mandatory program was implemented under the order to help reduce the potential for Salmonella in almonds. The board has developed forms as a means for persons to file required information with the board relating to the treatment of almonds to reduce the potential for Salmonella. Almond handlers are required to submit annual treatment plans to the board and inspection agency regarding how they plan to treat their almonds to reduce the potential for Salmonella. Entities interested in being almond process authorities that validate technologies are required to submit an application to the board on ABC Form No. 51, “Application for Process Authority for Almonds.” Manufacturers in the United States, Canada, and Mexico interested in being approved to accept untreated almonds, provided they agree to treat the almonds themselves under the board's Direct Verifiable (DV) program are required to submit an application to the board on ABC Form No. 52, “Application for Direct Verifiable (DV) Program for Further Processing of Untreated Almonds.” Entities interested in being approved DV user auditors are required to submit an application to the board on ABC Form No. 53, “Application for Direct Verifiable (DV) Program Auditors.”

The information collected would be used only by authorized representatives of USDA, including AMS, Fruit and Vegetable Programs' regional and headquarters' staff, and authorized employees and agents of the board. Authorized board employees, agents, and the industry are the primary users of the information and AMS is the secondary user.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 13.77 hours per response.

Respondents: Almond handlers; persons or organizations that would like to qualify to be board-approved process authorities that validate treatments and technologies; manufacturers who would like to qualify to participate in the board's DV program; and entities that would like to qualify as auditors under the DV program.

Estimated Number of Respondents: 175.

Estimated Number of Responses per Respondent: 1.74.

Estimated Total Annual Burden on Respondents: 4,200 hours.

Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Comments should reference this docket number and the appropriate marketing order and be sent to the USDA in care of the Docket Clerk at the address above. All comments received will be available for public inspection during regular business hours at the same address.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record.

Title: Guaranteed Loanmaking—Business and Industry Loans.

OMB Number: 0570-0017.

Expiration Date of Approval: February 28, 2010.

Type of Request: Extension of a Currently Approved Information Collection.

Abstract: The Business and Industry (B&I) Guaranteed Loan Program was legislated in 1972 under Section 310B of the Consolidated Farm and Rural Development Act, as amended. The purpose of the program is to improve, develop, or finance businesses, industries, and employment and improve the economic and environmental climate in rural communities. This purpose is achieved through bolstering the existing private credit structure through the guaranteeing of quality loans made by lending institutions, thereby providing lasting community benefits.

Estimate of Burden: Public reporting for this collection of information is estimated to average 2 hours per response.

Respondents: Business or other for-profit; State, Local or Tribal; Lenders, accountants, attorneys.

Estimated Number of Respondents: 870.

Estimated Number of Responses per Respondent: 1.

Estimated Number of Responses: 8,686.

Estimated Total Annual Burden on Respondents: 19,907 hours.

Copies of this information collection can be obtained from Linda Watts Thomas, Regulations and Paperwork Management Branch, Support Services Division at (202) 692-0226.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of RBS, including whether the information will have practical utility; (b) the accuracy of RBS's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to Linda Watts Thomas, Regulations and Paperwork Management Branch, Support Services Division, U.S. Department of Agriculture, Rural Development, STOP 0742, 1400 Independence Ave., SW., Washington, DC 20250. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

Agenda items to be covered include: (1) Vote on committee bylaws and elect a chairperson (2) Vote on Title II projects (3) Public Comment. The meeting is open to the public. Public input opportunity will be provided and individuals will have the opportunity to address the Committee at that time.

The United States Patent and Trademark Office (USPTO), pursuant to the Trademark Act, 15 U.S.C. 1051 et seq. and Chapter 37 of the Code of Federal Regulations, issues Office Actions in which it requests that applicants for trademark registration furnish information that is required for the issuance of a registration but that was not provided with the initial submission of the application for registration. The Response to Office Action form may be used to reply to an Office Action that was issued in connection with an application for registration or after the submission of a Statement of Use.

Additionally, applicants may supplement their applications by providing additional information voluntarily. When such information is provided before the USPTO has reviewed the application, the submission is in the nature of a Preliminary Amendment.

The Request for Reconsideration after Final Action is filed after issuance of a final Office Action but before the deadline for filing an appeal. Filing the Request for Reconsideration early in the six-month response period can eliminate the need for some appeals or petitions and reduce the need for remands and transfers of applications on appeal.

Applicants may also file a Post Publication Amendment in order to submit a proposed amendment to an application that has already been approved for publication by the examining attorney. If an applicant receives a Suspension Inquiry or Letter of Suspension from the USPTO, the applicant may use the response form to file a reply.

The forms in this collection are available in electronic format through the Trademark Electronic Application System (TEAS), which may be accessed on the USPTO Web site. Applicants may also submit the information in paper form by mail, fax or hand delivery.

OMB Number: 0651-0050.

Form Number(s): PTO Forms 1771, 1822, 1957, 1960 and 1966.

Type of Review: Revision of a currently approved collection.

Affected Public: Primarily business or other for-profit organizations.

Estimated Number of Respondents: 208,360 per year.

Estimated Time Per Response: The USPTO estimates that it will take approximately 10 minutes (0.17 hours) to 23 minutes (0.38 hours) to gather the necessary information, create the document, and submit the completed request, depending on whether the information is submitted electronically or on paper.

Estimated Total Annual Respondent Burden Hours: 57,416 hours per year.

Estimated Total Annual Respondent Cost Burden: $17,798,960. The USPTO believes that attorneys will complete the information in this collection. The professional hourly rate for attorneys in private firms is $310. This is a fully-loaded hourly rate. Therefore, the USPTO estimates that the respondent cost burden for this collection will be approximately $17,798,960 per year.

Estimated Total Annual (Non-hour) Respondent Cost Burden: $1,126. There are no capital start-up, operation, maintenance or record keeping costs, nor are there filing fees associated with this information collection.

Customers incur postage costs when submitting non-electronic information to the USPTO by mail through the United States Postal Service. The USPTO estimates that the majority of submissions for these paper forms are made via first class mail at a cost of 44 cents per submission. Therefore, the total estimated postage cost for this collection is $1,126 (2560 responses × $0.44).

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized or included in the request for OMB approval of this information collection; they will also become a matter of public record.

Section 101(a)(5)(A) of the MMPA (16 U.S.C. 1361 et seq. ) directs the NMFS to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by United States citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region, if certain findings are made by NMFS and regulations are issued. Under the MMPA, the term “taking” means to harass, hunt, capture, or kill or to attempt to harass, hunt capture, or kill marine mammals.

Authorization for incidental taking, in the form of annual LOAs, may be granted by NMFS for periods up to five years if NMFS finds, after notification and opportunity for public comment, that the taking will have a negligible impact on the species or stock(s) of marine mammals, and will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant). In addition, NMFS must prescribe regulations that include permissible methods of taking and other means effecting the least practicable adverse impact on the species and its habitat (i.e., mitigation), and on the availability of the species for subsistence uses, paying particular attention to rookeries, mating rounds, and areas of similar significance. The regulations also must include requirements pertaining to the monitoring and reporting of such taking. Regulations governing the taking incidental to EROS were published on June 19, 2008 (73 FR 34889), and remain in effect through July 19, 2013. For detailed information on this action, please refer to that Federal Register notice. The species that applicants may take in small numbers during EROS activities are bottlenose dolphins ( Tursiops truncatus ), Atlantic spotted dolphins ( Stenella frontalis ), pantropical spotted dolphins ( Stenella attenuata ), Clymene dolphins ( Stenella clymene ), striped dolphins ( Stenella coeruleoalba ), spinner dolphins ( Stenella longirostris ), rough-toothed dolphins ( Steno bredanensis ), Risso's dolphins ( Grampus griseus ), melon-headed whales ( Peponocephala electra ), short-finned pilot whales ( Globicephala macrorhynchus ), and sperm whales ( Physeter macrocephalus ).

Pursuant to these regulations, NMFS has issued an LOA to Tarpon Operating & Development, L.L.C. Issuance of the LOA is based on a finding made in the preamble to the final rule that the total taking by these activities (with monitoring, mitigation, and reporting measures) will result in no more than a negligible impact on the affected species or stock(s) of marine mammals and will not have an unmitigable adverse impact on subsistence uses. NMFS also finds that the applicant will meet the requirements contained in the implementing regulations and LOA, including monitoring, mitigation, and reporting requirements.

Review Joint Protocol; Status of Steller Sea Lion Biological Opinion; Discuss Board proposals potentially affecting federal groundfish fisheries; Status of proposed GOA cod federal actions; Status of chum salmon bycatch action; Crab and Scallop annual catch limits; Update on Council community outreach; Update on Walrus and fishery interaction issues; Update on Arctic Fishery Management Plan; Update on Federal Observer Program changes; Other business. The Agenda is subject to change, and the latest version will be posted at http://www.alaskafisheries.noaa.gov/npfmc/ .

Although other non-emergency issues not on the agenda may come before this group for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Gail Bendixen at (907) 271-2809 at least 7 working days prior to the meeting date.

On the first day of the meeting, the Standing and Special Reef Fish Scientific and Statistical Committees and the Red Snapper Advisory Panel will meet jointly to hear a presentation on the update stock assessment for red snapper. Following the presentation, the Scientific and Statistical Committees and Advisory Panel will reconvene separately to continue any discussion of the update stock assessment and make any management recommendations. The Scientific and Statistical Committees will evaluate the adequacy of the assessment for management purposes and will recommend a level of acceptable biological catch. The acceptable biological catch is a catch level which the Council cannot exceed when setting the annual catch limit for red snapper. The Scientific and Statistical Committees will also review a draft Acceptable Biological Catch Control Rule that is being developed by an Acceptable Biological Catch Control Rule Working Group, will discuss acceptable biological catch Control rules for data-moderate and data-poor stocks, review analyses of species groupings and recommend groupings for Acceptable Biological Catches, and discuss the next steps to take in the development of acceptable biological catch control rules. The recommendations made by the Scientific and Statistical Committees will be presented to the Council at its February 1 - 4, 2010 meeting in Mobile, AL.

Copies of the agenda and other related materials can be obtained by calling (813) 348-1630 or can be downloaded from the Council's ftp site, ftp.gulfcouncil.org .

Although other non-emergency issues not on the agenda may come before the Scientific and Statistical Committees for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Scientific and Statistical Committees will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Tina O'Hern at the Council (see ADDRESSES ) at least 5 working days prior to the meeting.

On the first day of the meeting, the Standing and Special Reef Fish Scientific and Statistical Committees and the Red Snapper Advisory Panel will meet jointly to hear a presentation on the update stock assessment for red snapper. Following the presentation, Special Reef Fish Scientific and Statistical Committees and the Red Snapper Advisory Panel will reconvene separately to continue any discussion of the update stock assessment and make any management recommendations. Other issues on the agenda include: red snapper season openings and closings, settlements for recreational fishing violations, and potential donation of seized catches. There will also be election of a chair and vice-chair. The comments and recommendations made by the Red Snapper Advisory Panel will be presented to the Council at its February 1 - 4, 2010 meeting in Mobile, AL.

Copies of the agenda and other related materials can be obtained by calling (813) 348-1630 or can be downloaded from the Council's ftp site, ftp.gulfcouncil.org .

Although other non-emergency issues not on the agenda may come before the Advisory Panel for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Advisory Panel will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Tina O'Hern at the Council (see ADDRESSES ) at least 5 working days prior to the meeting.

The documents being made available include (1) the proposed HCP, (2) the IA, and (3) the DEIS. This notice is provided pursuant to the ESA and the National Environmental Policy Act (NEPA) as amended. NMFS and FWS are furnishing this notice to allow other agencies and the public an opportunity to review and comment on these documents. All comments received will become part of the public record for this action. Hard bound copies of the HCP, IA, and DEIS are available for viewing, or for partial or complete duplication, at the following locations:

1. Siskiyou County Library, 719 4th St., Yreka, CA 96097.

2. Humboldt County Library, 1313 3rd St., Eureka, CA 95501.

3. Del Norte County Library, 190 Price Mall, Crescent City, CA 95531.

4. National Marine Fisheries Service, 1655 Heindon Rd., Arcata, CA 95521.

5. Yreka Fish and Wildlife Office, 1829 South Oregon St., Yreka, CA 96097.

Section 9 of the ESA prohibits the ''take'' of wildlife species listed as endangered or threatened by either the FWS or NMFS (16 USC 1538). The ESA defines the term ''take'' as to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect listed species, or attempt to engage in such conduct. “Harm” is defined to include significant habitat modification or degradation where it actually kills or injures wildlife by significantly impairing essential behavioral patterns, including breeding, feeding, spawning, migrating, rearing, and sheltering (64 FR 60727). Pursuant to section 10(a)(1)(B) of the ESA, FWS and NMFS may issue ITPs authorizing the take of listed species if, among other things, such taking is incidental to, and not the purpose of, otherwise lawful activities.

Take of listed plant species is not prohibited under the ESA, and cannot be authorized under a section 10 permit. However, the applicant proposes to include Yreka phlox (Phlox hirsuta) in the HCP to extend the plan's conservation benefits to this species. The applicant would receive assurances under the “No Surprises” regulations found in 50 CFR 17.22(b)(5), 17.32(b)(5), and 222.307(g) for all proposed covered species in the ITP.

To receive an ITP under the ESA, an applicant must prepare an HCP that specifies the following: (1) the impact of the taking; (2) steps the applicant will take to minimize and mitigate the impact; (3) funding available to implement the steps; (4) what alternative actions to the taking the applicant considered and the reasons why these actions were not taken; and (5) any other measures NMFS or FWS may require as being necessary or appropriate for the purpose of the plan (16 USC 1539(a)(2)(A)). To issue a permit, NMFS and FWS must find that: (1) the taking will be incidental; (2) the applicant will minimize and mitigate impacts of the take to the maximum extent practicable; (3) the applicant will ensure adequate funding for the HCP; (4) the taking will not appreciably reduce the likelihood of the survival and recovery of the species in the wild; and (5) the applicant will meet other measures required by FWS and NMFS. Regulations governing issuance of FWS permits for endangered and threatened species are at 50 CFR 17.22 and 17.32, and for NMFS-issued permits at 50 CFR 222.301 through 307.

The applicant has prepared a multi-species HCP and has applied for ITPs under the ESA. The HCP applies to 152,163 acres of commercial timberland owned by Fruit Growers Supply Company in Siskiyou County, California. The ownership consists of three management units: Klamath River (64,867 acres), Scott Valley (38,814 acres), and Grass Lake (48,482 acres). The Klamath River and Scott Valley management units are located west of Interstate 5, adjacent to and intermixed with Klamath National Forest (KNF) lands. The Grass Lake management unit (also adjacent to the KNF) lies east of Interstate 5 and predominantly north of State Highway 97. These lands are referred to as the Plan Area.

The applicant has requested coverage from FWS for northern spotted owl ( Strix occidentalis caurina ) and Yreka phlox ( Phlox hirsuta ), and from NMFS for the Southern Oregon/Northern California Coasts coho salmon ( Oncorhynchus kisutch ) Evolutionarily Significant Unit (ESU). The applicant also has requested coverage under the ITP for the unlisted Klamath and Trinity Rivers Chinook salmon ( O. tshawytscha ) ESU and the Klamath Mountains Province steelhead ( O. mykiss ) ESU. Should these unlisted covered species become listed under the ESA during the term of the permit, take authorization for those species would become effective upon listing. The HCP describes the habitat-based conservation approach, with species-specific objectives. This includes an Aquatic Species Conservation Program for salmonids and Terrestrial Species Conservation Program for the northern spotted owl and Yreka phlox.

Activities proposed for ITPs coverage include mechanized timber harvest; forest product transportation; road and landing construction, use, maintenance, and abandonment; site preparation; tree planting; certain types of vegetation management; silvicultural thinning and other silvicultural activities; fire suppression; rock quarry and borrow pit operations; aquatic habitat restoration; minor forest management activities such as forest product collecting; and monitoring activities and scientific work in the Plan Area.

The proposed duration of the ITPs and HCP is 50 years, though many aspects of the plan's conservation strategy are intended to benefit the covered species long into the future. The goals of this HCP are to: (1) protect and improve habitats required by species covered by the HCP and (2) establish appropriate guidelines for continuing timber harvests and other forest management activities.

NMFS and FWS formally initiated an environmental review of the project through publication of a Notice of Intent to prepare an Environmental Impact Statement in the Federal Register on February 22, 2008 (73 FR 9776). That document also announced a public scoping period during which interested parties were invited to provide written comments expressing their issues or concerns relating to the proposal and attend one of two public scoping meetings held in Yreka and Happy Camp, California.

NMFS and FWS have jointly prepared a DEIS to analyze the effects of alternatives on the human environment. Proposed issuance of the associated ITPs from both NMFS and FWS for covered species and applicant implementation of the HCP make up the Proposed Alternative in the DEIS. The other alternatives analyzed in the DEIS include: (1) the No Action Alternative (ITPs would not be issued and there would not be an HCP); (2) Alternative A (ITPs would be issued by both agencies, and northern spotted owl conservation areas would be based on the Northwest Forest Plan (NWFP) system of late-successional reserves (LSRs), and the Aquatic Species Conservation Program would be based on concepts outlined in the NWFP for the protection of aquatic habitats); and (3) Alternative B (FWS would issue an ITP for northern spotted owl, with spotted owl conservation based on management of foraging and dispersal habitat across the Plan Area).

If you wish to comment on the permit application, the HCP, IA, or DEIS, you may submit your comments to the address listed in the ADDRESSES section of this document. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment including your personal identifying information may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

The public meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Lisa Roberts, National Marine Fisheries Service (707) 825-5178, at least 5 working days prior to the meeting date.

NMFS and FWS will evaluate the applications, associated documents, and comments submitted to them to prepare a final EIS. A permit decision will be made no sooner than 30 days after the publication of the final EIS and completion of the Record of Decision.

All applicants must comply with all requirements contained in the Federal Funding Opportunity (FFO) announcements for each of these CIs.

CI Concept/Program Background: A CI is a NOAA-supported, nonfederal organization that has established an outstanding research program in one or more areas that are relevant to the NOAA mission. CIs are established at research institutions with outstanding graduate degree programs in NOAA-related sciences. CIs provide significant coordination of resources among all non-government partners and promote the involvement of students and postdoctoral scientists in NOAA-funded research. The CI provides mutual benefits with value provided by all parties. For each CI, NOAA has identified the need to establish a CI to focus on scientific research associated in support of NOAA's Strategic Plan, NOAA's 5-year Research Plan, and NOAA's 20-year Research Vision. (All documents are available at http://www.nrc.noaa.gov/plans.html ).

A CI may partner with one or more research institutions that demonstrate outstanding performance within one or more established research programs in NOAA-related sciences, including Minority Serving Institutions and universities that can contribute to the proposed activities of the CI. If a CI is awarded to a consortium of institutions, the consortium must propose a governance structure that includes a single director and one award.

CIs will conduct research under approved scientific research themes, described in detail in Section I.B of each Federal Funding Opportunity announcement. Activities of the CI are usually organized into three Tasks (additional tasks can be proposed by the CI).

i. Task I activities are related to the management of the CI, as well as general education and outreach activities. This task also includes support of postdoctoral and visiting scientists conducting activities within the research themes of the CI that are approved by the CI Director, in consultation with NOAA, and are relevant to NOAA and the CI's mission goals.

ii. Task II activities usually involve on-going direct collaboration with NOAA scientists. This collaboration typically is fostered by the collocation of Federal and CI employees.

iii. Task III activities require minimal collaboration with NOAA scientists and may include research funded by other NOAA competitive grant programs.

Base funding for Task 1 is provided annually by NOAA to the CI, contingent upon the availability of Federal appropriations. Throughout the award period, funding for additional Task I activities, as well as Task II and III (or other tasks by a particular CI) activities is added to the CI award as research project proposals are submitted by the CI and approved by NOAA.

Generally, applications must include all relevant Federal Standard Forms, a project description that includes sufficient information to address all the evaluation criteria identified in the FFO announcement, a budget, and a budget justification. The project description must include a thorough explanation of all themes and Tasks. The application should also identify the capability and the capacity of the CI to conduct research in the themes described in the FFO, as well as a summary of clearly stated goals to be achieved, reflecting NOAA's strategic goals and vision. Additional elements may also be requested. Applicants are directed to the FFO for all application information and requirements.

The proposed Pacific Northwest CI should possess outstanding capabilities to provide research under seven themes: (1) Ocean and coastal observations, (2) climate research and impacts, (3) environmental chemistry, (4) seafloor processes, (5) marine ecosystems, (6) protection and restoration of marine resources, and (7) tsunami observations and modeling. To conduct research under these themes, the proposed CI should possess the flexibility needed to work on multi-disciplinary research in collaboration with NOAA's Pacific Marine Environmental Laboratory, Climate Program Office, Alaska Fisheries Science Center, Northwest Fisheries Science Center, other CIs, and relevant Sea Grant programs. The location of the CI is required to be within a daily commuting distance to the Pacific Northwest NOAA facilities in Seattle, Washington, to promote ongoing close collaborations and training for the next generation of NOAA scientists. If the proposed CI is comprised of multiple member institutions, only the lead institution applying for the award and where the CI will be established must satisfy the daily commuting distance requirement.

Funding Availability: The award period will be 5 years, and may be renewed for up to an additional 5 years based on the outcome of a CI review in the fourth year. All funding is contingent upon the availability of Federal appropriations. NOAA anticipates that up to approximately $20M will be available annually for this CI. Of that amount, approximately $500,000 will be available per year for Task I. The final amount of funding available for Task I will be determined during the negotiation phase of the award based on availability of funding. The actual annual funding that the CI receives may be less than the anticipated amount and will depend on the actual projects that are proposed by the CI and approved by NOAA after the main CI award begins, the availability of funding, the quality of the research, the satisfactory progress in achieving the stated goals described in project proposals, and continued relevance to program objectives.

The proposed Southwestern U.S. CI should possess outstanding capabilities to provide research under four themes: (1) Climate and coastal observations, analysis and prediction; (2) climate research and impacts; (3) marine ecosystems; and (4) ecosystem management. To conduct research under these themes, the proposed CI should possess the flexibility needed to work on multi-disciplinary research in collaboration with NOAA's Southwest Fisheries Science Center, Climate Program Office, relevant Sea Grant programs, and other CIs. The location of the CI is required to be within a daily commuting distance to the Southwest Fisheries Science Center in La Jolla, California, to promote ongoing close collaborations with NOAA and training for the next generation of NOAA scientists. If the proposed CI is comprised of multiple member institutions, only the lead institution applying for the award and where the CI will be established must satisfy the daily commuting distance requirement.

Funding Availability: The award period will be 5 years, and may be renewed for up to an additional 5 years based on the outcome of a CI review in the fourth year. All funding is contingent upon the availability of Federal appropriations. NOAA anticipates that up to approximately $11M will be available annually for this CI. Of that amount, approximately $500,000 will be available per year for Task I. The final amount of funding available for Task I will be determined during the negotiation phase of the award based on availability of funding. The actual annual funding that the CI receives may be less than the anticipated amount and will depend on the actual projects that are proposed by the CI and approved by NOAA after the main CI award begins, the availability of funding, the quality of the research, the satisfactory progress in achieving the stated goals described in project proposals, and continued relevance to program objectives.

The proposed Southeastern Regional CI should possess outstanding capabilities to provide research under seven themes: (1) Sustained ocean and coastal observations, (2) climate research and impacts, (3) tropical weather, (4) ocean modeling, (5) ecosystem modeling and forecasting, (6) ecosystem management, and (7) protection and restoration of resources. To conduct research under these themes, the proposed CI should possess the flexibility needed to work on multi-disciplinary research in collaboration with NOAA's Southeast Fisheries Science Center, Atlantic Oceanographic and Meteorological Laboratory, relevant Sea Grant programs, and other CIs. The location of the CI is required to be within a daily commuting distance to NOAA's Atlantic Oceanographic and Meteorological Laboratory and Southeast Fisheries Science Center in Miami, Florida, to promote ongoing close collaborations with NOAA and training for the next generation of NOAA scientists. If the proposed CI is comprised of multiple member institutions, only the lead institution applying for the award and where the CI will be established must satisfy the daily commuting distance requirement.

Funding Availability: The award period will be 5 years, and may be renewed for up to an additional 5 years based on the outcome of a CI review in the fourth year. All funding is contingent upon the availability of Federal appropriations. NOAA anticipates that up to approximately $10M will be available annually for this CI. Of that amount, approximately $500,000 will be available per year for Task I. The final amount of funding available for Task I will be determined during the negotiation phase of the award based on availability of funding. The actual annual funding that the CI receives may be less than the anticipated amount and will depend on the actual projects that are proposed by the CI and approved by NOAA after the main CI award begins, the availability of funding, the quality of the research, the satisfactory progress in achieving the stated goals described in project proposals, and continued relevance to program objectives.

Electronic Access: Applicants can access, download, and submit electronic grant applications, including the full funding opportunity announcement, for NOAA programs at the Grants.gov Web site: http://www.grants.gov . The closing date will be the same as for the paper submissions noted in this announcement. For applicants filing through Grants.gov, NOAA strongly recommends that you do not wait until the application deadline date to begin the application process through Grants.gov. Registration may take up to 10 business days.

Proposals must include elements requested in the full Federal Funding Opportunity announcement on the grants.gov portal. If a hard copy application is submitted, NOAA requests that the original and two unbound copies of the proposal be included. Proposals, electronic or paper, should be no more than 75 pages (numbered) in length, excluding budget, investigators, vitae, and all appendices. Federally mandated forms are not included within the page count. Facsimile transmissions and electronic mail submission of full proposals will not be accepted.

Eligibility: Eligibility is limited to non-Federal public and private non-profit universities, colleges and research institutions that offer accredited graduate level degree-granting programs in NOAA-related sciences. The lead institution applying for the award and where the CI will be established must also satisfy the daily commuting distance requirement.

Cost Sharing Requirements: To stress the collaborative nature and investment of a CI by both NOAA and the research institution, cost sharing is required. There is no minimum cost sharing requirement; however, the amount of cost sharing will be considered when determining the level of the CI's commitment under NOAA's standard evaluation criteria for overall qualifications of applicants. Acceptable cost-sharing proposals include, but are not limited to, offering a reduced indirect cost rate against activities in one or more Tasks, waiver of any indirect costs assessed by the awardee on subawards, waiver of indirect costs assessed against base funds and/or Task I activities, waiver or reduction of any costs associated with the use of facilities at the CI, and full or partial salary funding for the CI director, administrative staff, graduate students, visiting scientists, or postdoctoral scientists.

Evaluation Criteria and Review and Selection Procedures: The general evaluation criteria and selection factors that apply to full applications to this funding opportunity are summarized below. The evaluation criteria for full applications will have different weights and details. Further information about the evaluation criteria and selection factors can be found in the official full Federal Funding Opportunity announcement which is only available through the Grants.gov Web site ( http://www.grants.gov ).

Evaluation Criteria for Projects: Proposals will be evaluated using the standard NOAA evaluation criteria. Various questions under each criterion are provided to ensure that the applicant includes information that NOAA will consider important during the evaluation, in addition to any other information provided by the applicant.

1. Importance and/or relevance and applicability of proposed project to the program goals (25 percent): This criterion ascertains whether there is intrinsic value in the proposed work and/or relevance to NOAA, Federal, regional, state, or local activities.

• Does the proposal include research goals and projects that address the critical issues identified in NOAA's 5-year Research Plan, NOAA's Strategic Plan, and program priorities ( see Section I.B. of the full funding opportunity announcement)?

• Is there a demonstrated commitment (in terms of resources and facilities) to enhance existing NOAA and CI resources to foster a long-term collaborative research environment/culture?

• Is there a strong education program with established graduate degree programs in NOAA-related sciences that also encourage student participation in NOAA-related research studies?

2. Technical/scientific merit (30 percent): This criterion assesses whether the approach is technically sound and/or innovative, if the methods are appropriate, and whether there are clear project goals and objectives.

• Does the project description include a summary of clearly stated goals to be achieved during the five year period that reflect NOAA's strategic plan and goals?

• Does the CI involve partnerships with other universities or research institutions, including Minority Serving Institutions and universities that can contribute to the proposed activities of the CI?

3. Overall qualifications of applicants (30 percent): This criterion ascertains whether the applicant possesses the necessary education, experience, training, facilities, and administrative resources to accomplish the project.

• If the institution(s) and/or principal investigators have received current or recent NOAA funding, is there a demonstrated record of outstanding performance working with NOAA and/or NOAA scientists on research projects?

• Is there nationally and/or internationally recognized expertise within the appropriate disciplines needed to conduct the collaborative/interdisciplinary research described in the proposal?

• Is there a well-developed business plan that includes fiscal and human resource management, as well as strategic planning and accountability?

• Are there any unique capabilities in a mission-critical area of research for NOAA?

• Has the applicant shown a substantial investment to the NOAA partnership, as demonstrated by the amount of the cost sharing contribution?

4. Project costs (5 percent): The budget is evaluated to determine if it is realistic and commensurate with the project needs and time-frame.

5. Outreach and education (10 percent): NOAA assesses whether this project provides a focused and effective education and outreach strategy regarding NOAA's mission to protect the Nation's natural resources.

Review and Selection Process: An initial administrative review/screening is conducted to determine compliance with requirements/completeness. All proposals will be evaluated and individually ranked in accordance with the assigned weights of the above-listed evaluation criteria by an independent peer review panel. At least three experts, who may be Federal or non-Federal, will be used in this process. If non-Federal experts participate in the review process, each expert will submit an individual review and there will be no consensus opinion. The merit reviewers' ratings are used to produce a rank order of the proposals. The Selecting Official selects proposals after considering the peer reviews and selection factors listed below. In making the final selections, the Selecting Official will award in rank order unless the proposal is justified to be selected out of rank order based upon one or more of the selection factors. The Selecting Official makes the final award recommendation to the Grants Officer authorized to obligate funds.

Selection Factors: The merit review ratings shall provide a rank order to the Selecting Official for final funding recommendations. The Selecting Official shall award in the rank order unless the proposal is justified to be selected out of rank order based upon one or more of the following factors:

1. Availability of funding.

2. Balance/distribution of funds:

(a) Geographically

(b) By type of institutions

(c) By type of partners

(d) By research areas

(e) By project types

3. Whether this project duplicates other projects funded or considered for funding by NOAA or other Federal agencies.

4. Program priorities and policy factors.

5. Applicant's prior award performance.

6. Partnerships and/or participation of targeted groups.

7. Adequacy of information necessary for NOAA staff to make a National Environmental Policy Act (NEPA) determination and draft necessary documentation before recommendations for funding are made to the Grants Officer.

Intergovernmental Review: Applications under this program are not subject to Executive Order 12372, “Intergovernmental Review of Federal Programs.”

Limitation of Liability: In no event will NOAA or the Department of Commerce be responsible for proposal preparation costs if these programs fail to receive funding or are cancelled because of other agency priorities. Publication of this announcement does not oblige NOAA to award any specific project or to obligate any available funds.

National Environmental Policy Act (NEPA): National Environmental Policy Act (NEPA). NOAA must analyze the potential environmental impacts, as required by NEPA, for applicant projects or proposals which are seeking NOAA federal funding opportunities. Detailed information on NOAA compliance with NEPA can be found at the NOAA NEPA Web site, http://www.nepa.noaa.gov , including our NOAA Administrative Order 216-6 for NEPA, http://www.corporateservices.noaa.gov/%7Eames/NAOs/Chap_216/naos_216_6.html , and the Council on Environmental Quality implementation regulations, http://www.nepa.gov/nepa/regs/ceq/toc_ceq.htm . Consequently, as part of an applicant's package, and under their description of their program activities, applicants are required to provide detailed information on the activities to be conducted, locations, sites, species and habitat to be affected, possible construction activities, and any environmental concerns that may exist (e.g., the use and disposal of hazardous or toxic chemicals, introduction of non-indigenous species, impacts to endangered and threatened species, aquaculture projects, and impacts to coral reef systems). In addition to providing specific information that will serve as the basis for any required impact analyses, applicants may also be requested to assist NOAA in drafting of an environmental assessment, if NOAA determines an assessment is required.

Applicants will also be required to cooperate with NOAA in identifying feasible measures to reduce or avoid any identified adverse environmental impacts of their proposal. The failure to do so shall be grounds for not selecting an application. In some cases if additional information is required after an application is selected, funds can be withheld by the Grants Officer under a special award condition requiring the recipient to submit additional environmental compliance information sufficient to enable NOAA to make an assessment on any impacts that a project may have on the environment.

The Department of Commerce Pre-Award Notification Requirements for Grants and Cooperative Agreements: The Department of Commerce Pre-Award Notification Requirements for Grants and Cooperative Agreements contained in the Federal Register notice of February 11, 2008 (73 FR 7696), are applicable to this solicitation.

Paperwork Reduction Act: This document contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA). The use of Standard Forms 424, 424A, 424B, and SF-LLL has been approved by the Office of Management and Budget (OMB) under the respective control numbers 4040-004, 4040-006, 0348-0040, and 0348-0046. Notwithstanding any other provision of law, no person is required to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA unless that collection of information displays a currently valid OMB control number.

Executive Order 12866: This notice has been determined to be not significant for purposes of Executive Order 12866.

Executive Order 13132 (Federalism): It has been determined that this notice does not contain policies with Federalism implications as that term is defined in Executive Order 13132.

Administrative Procedure Act/Regulatory Flexibility Act: Prior notice and an opportunity for public comment are not required by the Administrative Procedure Act or any other law for rules concerning public property, loans, grants, benefits, and contracts (5 U.S.C. 553(a)(2)). Because notice and opportunity for comment are not required pursuant to 5 U.S.C. 553 or any other law, the analytical requirements for the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are inapplicable. Therefore, a regulatory flexibility analysis has not been prepared.

On October 8, 2009, notice was published in the Federal Register (74 FR 51836) that a request for a scientific research permit to take shortnose sturgeon had been submitted by the above-named individual. The requested permit has been issued under the authority of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ) and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

The purpose of the proposed research is to maintain and conduct research on 95 hatchery-reared shortnose sturgeon at the University of Georgia to meet the following objectives: (1) quantify differences in the environmental tolerances of northern versus southern range shortnose sturgeon, and (2) evaluate ontogenetic changes in the environmental tolerances of juvenile shortnose sturgeon. The fish will be obtained from the Warm Springs National Fish Hatchery and Regional Fisheries Center (USFWS), Warm Springs, Georgia 31830, under NMFS Permit 1604. Using a series of replicated laboratory (lethal and non-lethal) experiments, the researcher will evaluate the individual, additive, and interactive effects of the three habitat variables most critical in determining summer habitat quality for both juveniles and adult shortnose sturgeon: maximum water temperature, maximum salinity, and minimum concentration of dissolved oxygen. Researchers will also examine how environmental tolerances of shortnose sturgeon change with age and conditioning (chronic exposure). Future scientific research with these fish will involve studies of nutrition, tagging, physiology, environmental tolerance, contaminants, fish health, behavioral, tagging, genetics, and fish culture techniques. The permit does not authorize any takes from the wild, nor does it authorize any release of captive sturgeon into the wild.

Issuance of this permit, as required by the ESA, was based on a finding that such permit (1) was applied for in good faith, (2) will not operate to the disadvantage of such endangered or threatened species, and (3) is consistent with the purposes and policies set forth in section 2 of the ESA.

KCBT and KCBTCC (Petitioners) jointly submitted a request to the Commission for an exemptive order under Section 4(c) of the CEA. 1 The order would permit KCBT to list certain wheat calendar swaps for “clearing only” and permit KCBTCC to clear those wheat calendar swaps (cleared-only contracts). 2 The contract size (5,000 bushels), position limits (5,000 contracts for any single month and 6,500 contracts for all months combined), and minimum price fluctuations ($.0025) of the cleared-only contracts would be the same as those of the KCBT wheat futures contract. However, the cleared-only contracts would be cash-settled, in contrast to KCBT's wheat futures contract, which is physically-settled, and would be listed for any of the 12 calendar months, as compared to the wheat futures contract which is listed only for March, May, July, September, and December.

The OTC wheat calendar swaps would be negotiated between eligible swap participants in the OTC market and then cleared by clearing members acting on behalf of their own customers or the customers of non-clearing member FCMs or non-member FCMs. Previous requests to clear OTC agricultural swaps were limited to clearing member FCMs acting on behalf of their own customers. 3

In support of their request, Petitioners represent that daily large trader reporting information allows KCBT to monitor for position concentration among non-clearing member and non-member FCMs, and the risk management and financial surveillance procedures of the non-clearing member and non-member FCMs' designated self-regulatory organizations (DSROs) are similar or identical to those employed by KCBT. The Commission requests comment on the impact of permitting the OTC wheat calendar swaps to be cleared by clearing FCMs on behalf of the customers of non-clearing member FCMs or non-member FCMs, and whether there are any conditions that should be placed upon DSROs or FCMs to facilitate risk management in connection with such transactions in the cleared-only contracts.

Part 35 of the Commission's regulations  4 exempts swap agreements and eligible persons entering into such agreements from most provisions of the CEA. 5 The term “swap agreement” is defined to include, among other types of agreements, a “commodity swap.”  6 Part 35 was promulgated pursuant to authority conferred upon the Commission in Section 4(c) of the CEA to exempt certain transactions in order to promote innovation and competition. 7 Various exemptions and exclusions were subsequently added to the CEA by the Commodity Futures Modernization Act of 2000 (CFMA), 8 but none apply to agricultural contracts. 9

Part 35 requires, among other things, that a swap agreement not be part of a fungible class of agreements that are standardized as to their material economic terms  10 and that the creditworthiness of any party having an interest under the agreement be a material consideration in entering into or negotiating the terms of the agreement. 11 Under the arrangement proposed by Petitioners, a cleared-only contract could be offset by another cleared-only contract. Thus, clearing of the OTC wheat calendar swaps would result in contracts that are fungible with other cleared-only contracts with equivalent terms. In addition, the creditworthiness of the counterparty would not be a consideration. Accordingly, the OTC swaps KCBTCC would clear would not satisfy all of the conditions of Part 35. 12

A. Background

The Commission is authorized under section 5(a) of the Consumer Product Safety Act (CPSA), 15 U.S.C. 2054(a), to conduct studies and investigations relating to the causes and prevention of deaths, accidents, injuries, illnesses, other health impairments, and economic losses associated with consumer products. Section 5(b) of the CPSA, 15 U.S.C. 2054(b), further provides that the Commission may conduct research, studies and investigations on the safety of consumer products or test consumer products and develop product safety test methods and testing devices.

In order to better identify and evaluate the risks of product-related incidents, the Commission staff seeks to solicit consumer opinions and perceptions related to consumer product use, on a voluntary basis, through questions posted on the CPSC's Consumer Opinion Forum. Through the forum, consumers will be able to answer questions and provide information regarding their experiences, opinions and/or perceptions on the use or pattern of use of a specific product or type of product. The Consumer Opinion Forum is intended for consumers, 18 years and older, who have access to the Internet and e-mail, who voluntarily register to participate through a participant registration process, and respond to the questions posted in the Consumer Opinion Forum. A link to the Consumer Opinion Forum login page is available on the CPSC Web site, http://www.cpsc.gov. Consumers may link directly to the login page for the Consumer Opinion Forum at https://www.cpsc.gov/cgibin/cof/login.aspx . When new questions are posted on the CPSC Web site, registered participants will be invited via e-mail to respond to various questions, but not more frequently than once every four weeks.

The information collected from the Consumer Opinion Forum will help inform the Commission's evaluation of consumer products and product use by providing insight and information into consumer perceptions and usage patterns. Such information may also assist the Commission in its efforts to support voluntary standards activities, and help the staff identify areas regarding consumer safety issues that need additional research. In addition, based on the information obtained, the staff may be able to provide safety information to the public that is easier to read and is more easily understood by a wider range of consumers. For example, the staff may be able to propose new language or revisions to existing language in warning labels or manuals if the staff finds that certain warning language is perceived by many participants to be unclear or subject to misinterpretation. Finally, the Consumer Opinion Forum may be used to solicit consumer opinions and feedback regarding the effectiveness of product recall communications and in determining what action is being taken by consumers in response to such communications and why. This may aid in tailoring future recall activities to increase the success of those activities. If this information is not collected, the Commission would not have available useful information regarding consumer experiences, opinions, and perceptions related to specific product use, which the Commission relies on in its ongoing efforts to improve the safety of consumer products on behalf of consumers.

During the past two years, 2,300 individuals have registered to participate in the Consumer Opinion Forum. Although the registration is still open, the Commission staff does not expect the number of registrants will exceed 5,000 over the next few years. The Commission staff estimates that each respondent will take 10 minutes or less to complete the one-time registration process. Based on that estimate, the registration burden is estimated to have been approximately 192 burden hours per year for 2,300 registrants.

The Commission staff further estimates that the amount of time required to respond to each set of questions on the Consumer Opinion Forum will be 5 minutes or less. The Commission staff foresees the possibility of up to 4 surveys per year. If, at the maximum, each respondent responds to 4 sets of questions over the course of a year, the yearly burden would result in approximately 20 minutes per year for each respondent. Based on an estimated 44 percent response rate for 2,300 potential respondents, the annual burden could total 337 hours. If as many as 5,000 registrants respond, the Commission staff estimates that the annual burden could total approximately 733 hours per year (44 percent response rate for 5,000 potential respondents at 5 minutes per survey for four surveys).

The Commission staff estimates that the total estimated burden for new registrations and surveys, combined, will not exceed 925 hours annually (no more than 733 hours for four surveys per year, plus no more than 192 hours for new registrations). The Commission staff estimated the value of the time of respondents to this collection of information at $29.39 an hour. This is based on the 2009 U.S. Department of Labor Employer Costs for Employee Compensation. At this valuation, the estimated annual cost to the public of this information collection will be about $27,000 per year.

The Commission will expend approximately 1 month of professional staff time annually for preparing questions and analysis of responses for each survey. Assuming that 4 surveys will be conducted annually, (and 4 staff months) the total annual cost to the Federal government of the collection of information is estimated to be $55,360.

The Commission solicits written comments from all interested persons about the proposed collection of information. The Commission specifically solicits information relevant to the following topics:

—Whether the collection of information described above is necessary for the proper performance of the Commission's functions, including whether the information would have practical utility;

—Whether the estimated burden of the proposed collection of information is accurate;

—Whether the quality, utility, and clarity of the information to be collected could be enhanced; and

—Whether the burden imposed by the collection of information could be minimized by use of automated, electronic or other technological collection techniques, or other forms of information technology.

Section 14(a)(1) of the Consumer Product Safety Act (CPSA) (15 U.S.C. 2063(a)(2)), as amended by the Consumer Product Safety Improvement Act of 2008 (CPSIA), establishes requirements for the testing and certification of products subject to a consumer product safety rule under the CPSA or similar rule, ban, standard, or regulation under any other Act enforced by the Commission and which are imported for consumption or warehousing or distributed in commerce. Under section 14(a)(1)(A) of the CPSA, manufacturers and private labelers must issue a certificate which “shall certify, based on a test of each product or upon a reasonable testing program, that such product complies with all rules, bans, standards, or regulations applicable to the product under the CPSA or any other Act enforced by the Commission.” CPSC regulations, at 16 CFR part 1110, further define the certificate requirement as applying only to importers and domestic manufacturers. Section 14(a)(1)(B) of the CPSA further requires that the certificate provided by the importer or domestic manufacturer “specify each such rule, ban, standard, or regulation applicable to the product.” The certificate described in section 14(a)(1) of the CPSA is known as a General Conformity Certification.

Section 14(a)(2) of the CPSA (15 U.S.C. 2063(a)(2)) establishes testing requirements for children's products that are subject to a children's product safety rule. (Section 3(a)(2) of the CPSA (15 U.S.C. 2052(a)(2)) defines a children's product as a consumer product designed or intended primarily for children 12 and younger.) Section 14(a)(2)(A) of the CPSA also states that, before a children's product that is subject to a children's product safety rule is imported for consumption or warehousing or distributed in commerce, the manufacturer or private labeler of such children's product must submit sufficient samples of the children's product “or samples that are identical in all material respects to the product” to an accredited “third party conformity assessment body” to be tested for compliance with the children's product safety rule. Based on such testing, the manufacturer or private labeler, under section 14(a)(2)(B) of the CPSA, must issue a certificate that certifies that such children's product complied with the children's product safety rule based on the assessment of a third party conformity assessment body accredited to perform such tests.

Section 14(d)(2)(A) of the CPSA requires the Commission to initiate a program by which a manufacturer or private labeler may label a consumer product as complying with the certification requirements. This provision applies to all consumer products that are subject to a product safety rule administered by the Commission.

Section 14(d)(2)(B) of the CPSA requires the Commission to establish protocols and standards for:

• Ensuring that a children's product tested for compliance with a children's product safety rule is subject to testing periodically and when there has been a material change in the product's design or manufacturing process, including the sourcing of component parts;

• Testing of random samples;

• Verifying that a children's product tested by a conformity assessment body complies with applicable children's product safety rules; and

• Safeguarding against the exercise of undue influence on a third party conformity assessment body by a manufacturer or private labeler.

Although section 14 of the CPSA appears to impose the same testing and certification requirements for consumer products and for children's products, there are significant differences between consumer products, children's products, manufacturers, and even testing methods and sampling methods. These differences make it difficult to devise a regulatory approach that is:

• General enough to apply to most, if not all, consumer products subject to section 14 of the CPSA;

• Detailed enough so that interested parties know what tests need to be performed, how often those tests need to be performed, and how many samples need to be tested;

• Rigorous enough so that the test results provide confidence that all (rather than most or some) consumer products comply with consumer product safety rules; and

• Sensitive enough to the needs of small businesses and individuals, such that any regulatory program designed to implement section 14 of the CPSA does not prove so costly or so burdensome as to drive those small businesses and individuals out of business regardless of the quality or safety of the products they make.

For example, one can imagine that the testing requirements that apply to a manufacturer who makes tens of thousands of electronic toys that will be sold at retail outlets throughout the world will and should differ from the testing requirements that apply to an individual who hand-carves ten wooden toys and sells them at local craft shows. Nevertheless, under section 14 of the CPSA, the electronic toys and wooden toys both may fit the definition of “children's product” and be subject to testing by a third party conformity assessment body. Similarly, one can imagine that a large manufacturer has the financial and technical resources and sophistication to devise testing programs and to source its products to ensure that the product and the components used to make the product comply with consumer product safety rules, whereas an individual might not. Nevertheless, under section 14 of the CPSA, both the large manufacturer and the individual must test and certify their products and must specify each such rule, ban, standard, or regulation applicable to the product.

The Commission, therefore, will conduct a two-day workshop to discuss possible options for implementing section 14 of the CPSA. We believe that a properly structured testing program will greatly reduce the likelihood of unsafe or otherwise non-compliant products entering the market. A properly structured testing and certification program also may result in fewer product recalls and CPSC enforcement actions, increased consumer confidence, and safer consumer products.

In general, the workshop will focus on the following topics:

• Reasonable Testing Programs;

• Additional Third-Party Testing Requirements for Children's Products;

• Issues Affecting Importers and Small Businesses;

• The Consumer Product Labeling Program; and

• Certification.

We address these topics in greater detail in parts III.A through III.E of this document.

As explained in part I of this document, section 14(a)(1)(A) of the CPSA requires manufacturers and private labelers of a product which is subject to a consumer product safety rule under the CPSA or similar rule, ban, standard, or regulation under any other Act enforced by the Commission to issue a certificate that is based on a test of each product or upon a reasonable testing program. Section 14(a)(1)(A) of the CPSA, however, begins with the phrase “except as provided by” section 14(a)(2) and (a)(3) of the CPSA. (Section 14(a)(2) of the CPSA pertains to third party testing of children's products while section 14(a)(3) of the CPSA establishes a schedule for third party testing.) While one might interpret the “except for” clause in section 14(a)(1) of the CPSA as not extending the “reasonable testing program” requirement to children's products, section 14(b) of the CPSA authorizes the Commission to prescribe reasonable testing programs for any product subject to a consumer product safety rule under the CPSA or a similar rule, regulation, standard, or ban under any other Act enforced by the Commission and for which a certificate is required under section 14(a) of the CPSA. Thus, because children's products are subject to a certificate requirement under section 14(a) of the CPSA, the Commission, by regulation, may prescribe a reasonable testing program for children's products.

We envision a reasonable testing program as having five elements regardless of the quantity of product manufactured or the size of the importer or manufacturer. The five elements are:

• Product specifications that describe the consumer product and list the safety rules, standards, etc., with which the product must comply. The product specification should include a complete description of the product and any other information, including, but not limited to, a bill of materials, parts listing, raw material selection and sourcing, and/or model names or numbers of items necessary to describe the product and differentiate it from other products.

• Certification tests which are performed on samples of the manufacturer's consumer product to demonstrate that the product is capable of passing the tests prescribed by the standard.

• A production testing plan which describes the tests that must be performed and the testing intervals to provide reasonable assurance that the products as produced meet all applicable safety rules.

• A remedial action plan which must be employed whenever samples of the consumer product or results from any other tests used to assess compliance yield unacceptable or failing test results.

• Documentation of the reasonable testing program and how it was implemented.

We invite discussion and comment on the following issues pertaining to a “reasonable testing program:”

• Certain CPSC regulations, such as 16 CFR 1203.33(b) (describing characteristics of a “reasonable testing program” for testing bicycle helmets) include product specifications, certification testing, production testing, and corrective action as elements of a “reasonable testing program.” However, those other CPSC regulations tend to be specific to a single product type and affect a limited number of manufacturers. In part III.A.1 of this document, we described the five elements we believe should constitute a “reasonable testing program” for all manufacturers. Please discuss whether the five elements are appropriate for all manufacturers and whether additional requirements or modifications should be made. For example, we have heard about one testing program that evaluates hazards and risk assessment when the product is being designed; this step would occur before any testing is conducted, so one might consider whether additional requirements should be part of a reasonable testing program or modifications to the CPSC's five elements. Please identify any references, standards, and other regulatory approaches that may be helpful.

• What factors should be considered to determine a reasonable frequency for production testing? For example, should the frequency for testing product samples be determined by production volume, the amount of time that has elapsed since the product was last tested, or some combination of those two and/or other factors? How should the testing frequency be determined for very low volumes or seasonal production? What rationale should be used to determine the frequency of production testing? What references, standards, or models exist?

○ Should the potential hazard (either the severity or the probability of occurrence) be considered in determining how frequently the testing is conducted? For example, should a product subject to a consumer product safety rule, where the potential hazard is death, be tested more frequently than a product where the potential hazard is some lesser degree of harm? If so, how might a rule incorporate potential hazard into testing frequency?

• How should a reasonable testing program requirement address the number of samples to be tested? Production volumes can vary tremendously among manufacturers; one manufacturer might make hundreds of thousands of the same item, whereas an individual who hand-weaves or carves a product might make only one item. Please identify any references, standards, and other regulatory approaches that may be helpful.

• How might component or batch testing be incorporated into a “reasonable testing program?” What circumstances would warrant new component or batch testing?

○ Under what circumstances should component testing be permitted or not permitted?

○ Are there particular types of component testing which should or should not be permitted?

○ What are the potential problems in or obstacles to using component testing?

• Section 19(a)(6) of the CPSA makes it unlawful for any person to fail to furnish a certificate required by the CPSA or any other act enforced by the Commission or to issue a false certificate if such person “in the exercise of due care has reason to know that the certificate is false or misleading in any material respect * * *.” If, under a reasonable testing program, a manufacturer may rely on certificates provided by a component supplier, what criteria or factors should we consider in determining whether a manufacturer has exercised “due care?” How might a reasonable testing program's results apply in determining whether a certificate is false or misleading?

• What problems (if any) will small manufacturers or manufacturers of low volume products encounter in establishing a reasonable testing program as described in part III.A.1 of this document? To what extent do small businesses or manufacturers of low volume products already have procedures in place that are intended to ensure that their products meet the applicable product safety rules?

• What quality assurance procedures do manufacturers use now that might overlap with the reasonable testing program envisioned here?

Section 14(d)(2)(B)(i) of the CPSA requires the Commission to establish protocols and standards for ensuring that a children's product tested for compliance with a children's product safety rule is subject to testing periodically and when there has been a material change in the product's design or manufacturing process, including the sourcing of component parts.

• Should the potential hazard (either the severity or the probability of occurrence) be considered in determining how frequently the periodic testing is conducted? For example, should a product subject to a consumer product safety rule, where the potential hazard is death, be tested more frequently than a product where the potential hazard is some lesser degree of harm? If so, how might a rule incorporate potential hazard into testing frequency?

• What changes should constitute a “material change” in a product's design or manufacturing process? Are there criteria by which one might determine whether a change is a “material” change? For example, a material change in a product's design or manufacturing process could be described as a change that affects the product's ability to comply with a consumer product safety rule. However, as a practical matter, it may be difficult to determine what consumer product safety rules apply to the product and the extent to which compliance with those rules is affected by a change.

• Under what circumstances or conditions might the testing be limited to the change itself? For example, assume that a product is painted using paint made by Paint Company A, but then the product manufacturer changes to use paint made by Paint Company B. Would it be acceptable to test only the paint made by Paint Company B, under section 14(d)(2)(B)(i) of the CPSA, rather than test the entire product?

• Section 14(d)(2)(B)(ii) of the CPSA refers to the “testing of random samples to ensure continued compliance.” What constitutes a “random sample?” How should the sample be collected, and who should collect it? How should a regulation address the number of samples to be tested? Please identify any references, standards, and other regulatory approaches that may be helpful. For products that are arguably unique, such as hand-made or custom products, what would constitute a “random sample?”

• Section 14(d)(2)(B)(iii) of the CPSA requires the Commission to establish protocols and standards for “verifying that a children's product tested by a conformity assessment body complies with applicable children's product safety rules.” What requirements or procedures are needed to verify compliance? Who conducts the verification process and how? For example, should verification be done by a different third party conformity assessment body and using the same tests that were applied to the children's product? How often should verification be conducted? Please identify any references, standards, and other regulatory approaches that may be helpful.

• Section 14(d)(2)(B)(iv) of the CPSA requires the Commission to establish protocols and standards for “safeguarding against the exercise of undue influence” on third party conformity assessment bodies.

○ What specific requirements should a rule specify to ensure that a third party conformity assessment body is safeguarded against undue influence by a manufacturer or private labeler?

○ What specific requirements should a rule establish to ensure that manufacturers and private labelers do not exercise or attempt to exercise undue influence on third party conformity assessment bodies?

Currently, the notices of requirements we have issued for the accreditation of third party conformity assessment bodies specify that “firewalled” conformity assessment bodies (which are third party conformity assessment bodies that are owned, managed, or controlled by a manufacturer or private labeler) must submit to the Commission copies, in English, of their training documents showing how employees are trained to notify the Commission immediately and confidentially of any attempt by the manufacturer, private labeler, or other interested party to hide or exert undue influence over the third party conformity assessment body's test results. We have heard recommendations to strengthen or increase the evidence needed to protect against the exercise of undue influence and to apply such recommendations to all third party conformity assessment bodies and perhaps to manufacturers and private labelers. For example, individual employees could sign documents acknowledging that they are aware of and/or have received training pertaining to safeguards against undue influence. Please identify any references, standards, and other regulatory approaches that may be helpful.

• What provisions (if any) should be made for small manufacturers and manufacturers with low production volumes and why? For example, specifying the frequency of periodic testing or the number of random samples to be tested may be inappropriate where the volume of children's products being manufactured is low or where the children's product is one-of-a-kind.

• Although the enforcement of most third party testing requirements of the CPSA has been stayed at least until February 10, 2010 (74 FR 6396 (February 9, 2009)), many manufacturers and importers have subjected their products to third party testing. We are interested in learning about:

○ The experiences of firms in obtaining third party testing, including information on the actual testing costs, and the experiences of small firms and crafters, especially those with no more than a few employees or with low volume products ( e.g. , less than 10,000 units per year);

○ Testing costs and the possible impacts of required periodic testing on the financial health of the businesses;

○ The use of component testing to reduce the cost of testing or the potential for using component testing for lowering the cost of testing;

○ The circumstances under which component testing should or should not be permitted. For example, component testing may be appropriate for testing parts for lead and for phthalates, but inappropriate for testing pursuant to 16 CFR part 1203 (Safety Standard for Bicycle Helmets). As another example, one might argue that component testing may be appropriate for raw materials under certain circumstances, but that certain items should not be considered to be “component” and, therefore, are not appropriate for component testing. How might we define “component?” May the Consumer Product Safety Improvement Act of 2008 be read to require foreign manufacturers of components meant for children's products to issue certifications?;

○ Whether particular types of component testing should or should not be permitted. For example, assume that the product is a doll with painted eyes. If a manufacturer can develop a sample doll whose entire head is painted, using the same paint as used for the eyes, a testing laboratory would be able to obtain a sufficient paint sample from a smaller number of sample dolls compared to the number of dolls that would need to be tested if the manufacturer's samples had to have the same sized painted eyes as the dolls to be sold on the market. As another example, assume that a product is assembled in pieces; if a manufacturer can test the pieces before assembling the product, a testing laboratory would not have to receive an assembled final product and then break the product down into pieces for testing; and

○ The potential problems in or obstacles to using component testing.

We recognize that importers, small businesses, and others may operate in an environment that may differ significantly from that of large manufacturers. For example, importers may acquire their product from many sources, including manufacturing operations under their control and contract manufacturers or foreign wholesalers that are not under their control. If an importer is not directly involved in the manufacturing process, its ability to monitor and control the manufacturing process may be limited.

• How might an importer involved with a contract manufacturer ensure testing is conducted when the source of a component part changes? We seek information on approaches that will ensure that consumer products comply with consumer product safety rules and similar rules, bans, standards, or regulations under other acts enforced by the Commission while recognizing that importers and others may face constraints due to their lack of direct involvement in the manufacture and production of the consumer product.

• Many small businesses have expressed concerns about the implementation of section 14(a)(2) of the CPSA, particularly small businesses importing or manufacturing children's products which require testing by a third party conformity assessment body. While we do not have sufficient information regarding the size or production volume of all children's product manufacturers, the information that is available suggests that, in 2006, 98 percent of domestic firms manufacturing toys, dolls, and/or games employed fewer than 500 employees, and 81 percent employed fewer than 20 employees. ( See Employer Firms, & Employment by Employment Size of Firm by NAICS Codes, 2006 (North American Industry Classification System (NAICS) Code 33993 pertaining to the doll, toy, and game manufacturing industry), available on the Internet at http://www.sba.gov/advo/research/us06_n6.pdf. )

○ There will be an economic impact on all parties required to obtain third party testing of children's products. Those dealing with higher volumes may be able to amortize the testing costs over a larger volume of product, thereby reducing the incremental per-piece testing cost. However, requiring all businesses to abide by the same protocols and standards, regardless of their size or methods of production, may burden the smallest volume businesses with significant testing costs. We seek a better understanding of the potential cost impact on these smaller businesses and how a testing program pursuant to section 14(d)(2)(B) of the CPSA might be structured to minimize the cost burden while ensuring product safety.

○ Small businesses producing a very small volume of children's products, often custom-ordered, present unique challenges. These small businesses often buy small quantities of components at retail establishments. These components often are not children's products when sold at retail and therefore are not subject to the third party testing requirements. However, when the components are used to manufacture a children's product, they must meet all applicable standards. For example, a plain button sold at retail is not a children's product and is not subject to third party testing. If the same button is used to manufacture a toy, the button becomes a component of a children's product and becomes subject to the third party testing requirement and to children's product safety rules. We invite comment on possible approaches for product testing, including component testing, in these situations.

Section 14(d)(2)(A) of the CPSA requires the Commission to initiate, by regulation, a program by which a manufacturer or private labeler may label a consumer product as complying with the certification requirements in section 14(a) of the CPSA for consumer products and for children's products.

We believe that the party certifying the consumer product is responsible for ensuring that the product complies with all applicable consumer product safety rules or similar rules, bans, standards, or regulations under any other act enforced by the Commission and that only the party certifying the product's compliance, or its authorized representative, may affix the label to the consumer product. We also believe that the label should be affixed before the consumer product is placed on the market and should be affixed to the product packaging or, if there is no packaging, to the product or on a tag or other material included with the product.

• What requirements, if any, should be specified as part of the label program? For example, should a rule specify the label's text or provide other specifications such as size, color, font, and location? Should a rule impose any restrictions on the label's use? If so, what should the specifications or restrictions be?

• What challenges, if any, would a label program present to manufacturers, such as manufacturers of certain products or small manufacturers, and how could such challenges be addressed?

Section 14(g)(3) of the CPSA states that every certificate required under section 14 of the CPSA “shall accompany” the product or shipment of products covered by the same certificate and that a copy of the certificate shall be furnished to each distributor or retailer. Section 14(g)(4) of the CPSA allows for electronic filing of certificates up to 24 hours before arrival of an imported product and directs manufacturers and private labelers to furnish a copy to the Commission and to the Commissioner of Customs upon request.

• What constitutes or should constitute “accompanying” the product or shipment?

• In the Federal Register of November 18, 2008 (73 FR 68328), we issued a final rule discussing, among other things, the electronic certificate. The final rule allowed an electronic certificate to “accompany” the product or shipment if the certificate is identified by a unique identifier and can be accessed through a World Wide Web URL or other electronic means as long as the URL or other electronic means and the unique identifier are created in advance and are available to the Commission or to Customs and Border Protection when the product is available for inspection. The final rule also stated that importers and domestic manufacturers and private labelers satisfy the requirement of “furnishing” the certificate to distributors and retailers if they are given “a reasonable means to access the certificate.” ( See 16 CFR 111.13, “Availability of electronic certificate”.) The final rule, however, gave no specific details on what constitutes a “unique identifier,” “other electronic means,” or “reasonable means.” What changes, if any, are needed to the rule regarding electronic certificates? Should foreign manufacturers be required to issue a certificate?

The workshop will be held from 9:30 a.m. to 4 p.m. on Thursday, December 10, 2009, and Friday, December 11, 2009 at the CPSC's headquarters building at 4330 East West Highway, Bethesda, Maryland 20814, in the 4th Floor Hearing Room.

The workshop will open with a review of CPSC staff's current work on sections 14(a) and 14(d)(2) of the CPSA, including a discussion of the factors involved in sampling and an overview of the economic issues, followed by break-out sessions on the following subjects:

• The Consumer Product Labeling Program;

• Reasonable Testing Programs;

• Sampling Plans;

• Safeguarding Against Undue Influence on Product Testing;

• Additional Third-Party Testing Requirements for Children's Products; and

• Verification of Children's Product Testing Results.

If you do not wish to make a presentation, you do not need to notify the CPSC, but please be aware that seating will be on a first-come, first-served basis.

If you need special accommodations because of disability, please contact Mr. Howell at least 7 days before the workshop.

In addition, we encourage written or electronic comments to the docket. Written or electronic comments will be accepted until January 11, 2010. Please note that all comments should be restricted to how the CPSC should interpret and implement the requirements found in sections 14(a) and 14(d)(2) of the CPSA so as to promote increased product safety while minimizing possible adverse impacts or unintentional consequences of the implementing regulations to be developed.

1. Description of Proposed Project: The proposed reservoir dam would be located in Bois d'Arc Creek, in the Red River watershed, approximately 15 miles northeast of the town of Bonham, between Farm-to-Market (FM) Road 1396 and FM Road 409, in Fannin County, TX. The proposed project site consists of 17,068 acres. Approximately 38 percent of the project site is cropland, 37 percent is bottomland hardwoods and riparian woodlands. The remaining 25 percent is mostly upland deciduous forest.

The purpose of the proposed project is to impound the waters of Bois d'Arc Creek and its tributaries to create a new 16,641 acre water supply reservoir for NTMWD. Approximately 427 acres would be required for the construction of the dam and spillways. NTMWD has requested the right to impound up to 367,609 acre-feet of water, to produce an estimated firm yield of 126,200 acre-feet of water per year. State population projections show the NTMWD service population to increase from 1.6 million to 3.3 million by 2060. The Lower Bois d'Arc Creek Reservoir would provide a new water supply to help meet this increasing demand.

Lower Bois d'Arc Creek Reservoir Dam would be about 10,400 feet in length and would have a maximum height of about 90 feet. The design top elevation of the embankment would be 553.5′ msl with a conservation pool elevation of 534.0′ msl controlled by a service spillway at elevation 534.0′ msl with a crest length of 150 feet. The service spillway would be located at the right (east) abutment of the dam. Required low-flow releases would be made through a 36-inch diameter low-flow outlet. An emergency spillway would also be located in the right abutment of the dam. The emergency spillway would be a 1,400-foot wide uncontrolled broad crested weir structure with a crest elevation of 541′ msl. This elevation was selected to contain the 100-year storm such that no flow passes through the emergency spillway during this event.

Raw water from the reservoir would be transported by 29 miles of 90-inch pipeline to a proposed water treatment plant near the City of Leonard in southwest Fannin County. To allow the NTMWD the ability to treat water from Lower Bois d'Arc Creek Reservoir at its existing facilities in Wylie, TX, 14 miles of 66-inch pipeline would also extend from the water treatment plant to an outfall on Pilot Grove Creek, a tributary of the East Fork of the Trinity River, to deliver raw water to Lake Lavon, in the Trinity River basin.

Construction of the dam and impoundment of the water within the normal pool elevation of 534′ msl would result in direct fill impact or inundation of approximately 120 acres of perennial streams, 99 acres of intermittent streams, 87 acres of open water, 4,602 acres of forested wetlands, 1,223 acres of herbaceous wetlands, and 49 acres of shrub wetlands.

2. Alternatives: Alternatives available to the USACE are to: (1) Issue the Department of the Army permit; (2) issue the Department of the Army permit with special conditions; or (3) deny the Department of the Army permit. Alternatives available to NTMWD include: (1) Construct Lower Bios d'Arc Creek Reservoir as proposed; (2) construct Lower Bois d'Arc Creek Reservoir as proposed by NTMWD, with modifications; (3) developing or acquiring other water supply sources; or (4) no action. As part of the EIS process, a full range of reasonable alternatives, including the applicant's preferred alternative, will be evaluated.

3. Scoping and Public Involvement: A public notice for the Section 404 CWA permit application was issued on the proposal on October 14, 2008 soliciting comments from federal, state, and local agencies and officials, interested individuals and the general public. The 30-day comment period was extended by 30 days until December 12, 2008 to afford ample opportunity for public and agency comment on this project. A public Scoping Meeting will be held regarding the proposed action to seek public comments on the proposed project and its potential effects to the human environment ( See DATES AND ADDRESSES ). The USACE will be conducting the public scoping meeting to describe the project, preliminary alternatives, the NEPA compliance process, and to solicit input on the issues and alternatives to be evaluated and other related matters. Written comments for scoping will be accepted until January 9, 2010.

4. Significant Issues: Issues to be given analysis in the EIS are likely to include, but will not be limited to: The effects of the lake on the immediate and adjacent property owners, nearby communities, downstream hydraulics and hydrology, wetlands, surface water quality and quantity, groundwater quality and quantity, geological resources, vegetation, fish and wildlife, federally-listed threatened and endangered species, soils, prime farmland, noise, light, aesthetics, historic and pre-historic cultural resources, socioeconomics, land use, public lands, public roads, air quality, and the effects of construction of related facilities.

5. Cooperating Agencies: The USACE has invited the U.S. Environmental Protection Agency, U.S. Fish and Wildlife Service, U.S. Forest Service, Texas Commission on Environmental Quality, Texas Parks and Wildlife Department, Texas Historical Commission, and Texas Water Development Board to be Cooperating Agencies (CA) in the formulation of the EIS. No decisions have been made on CA status at this time. Regardless of final CA status decisions, these agencies, as well as other federal, tribal, state, and local governmental entities are expected to be involved in the review and comment of the Draft EIS.

6. Additional Review and Consultation: Compliance with other Federal and State requirements that will be addressed in the EIS include, but are not limited to, state water quality certification under Section 401 of the CWA, protection of water quality under the Texas Pollutant Discharge Elimination System, protection of air quality under the Texas Air Quality Act, protection of endangered and threatened species under Section 7 of the Endangered Species Act, and protection of cultural resources under Section 106 of the National Historic Preservation Act.

7. Availability of Draft EIS: The Draft EIS is projected to be available by September 2010. There will be a public comment cycle (a public meeting(s) and opportunity for public hearing) following the release of the Draft EIS.

The Army has decided to proceed with implementing the Preferred Alternative (Alternative 2) identified in the FEIS to reorganize and augment its aviation assets in Alaska as an Aviation Task Force (ATF). The ATF will be formed by augmenting USARAK's existing assigned aviation assets (approximately 490 Soldiers and 32 helicopters) with 710 additional Soldiers and 40 additional helicopters. Alternative 2 will result in 1,200 total Soldiers and 72 total helicopters at Fort Wainwright (FWA), with a total projected population increase of approximately 2,005 (including Soldiers, Family members, and Civilian support personnel). The ATF will be permanently stationed at FWA. Construction of new facilities as well as demolition within the FWA Main Post and operation of additional generators and vehicles will be required. Training will occur on current USARAK training lands and use existing flight corridors.

By choosing to implement Alternative 2 in the ROD, the Army expects direct, indirect, and cumulative impacts as a result of troop stationing, facilities construction, and helicopter training exercises at USARAK. The principal environmental impacts will be to airspace management, cultural and visual resources, noise, hazardous materials and hazardous waste, and wildlife. Although additional helicopters will be stationed in Alaska, existing airspace aviation travel routes will be utilized, resulting in minor increases in air traffic. Significant adverse impacts will occur to the Ladd Field National Historic Landmark as a result of facility construction at FWA. Adverse impacts will be the result of the new construction being out of scale with historic buildings, historical viewshed obstruction and change in use of two historic buildings. Temporary minor noise impacts will occur due to facility construction. Noise associated with helicopter training will increase but not to a level that will significantly increase annoyance levels at FWA or surrounding lands. Hazardous materials and waste, both existing sources and those created by the stationing and operation of an aviation unit, will be managed under existing programs and agreements. Facility construction is proposed within known areas of contamination. USARAK will continue to consult with the appropriate State and federal agencies as outlined in existing agreements in order to protect human health and the environment. Various wildlife species will be affected by increased military training, specifically moose, bison, caribou, trumpeter swan, and bear; however, population level impacts will not occur. In addition, increased hunting pressure on game mammals could result from increased stationing of Soldiers.

As part of the decision to implement Alternative 2 at FWA, the Army will enact environmental mitigation measures to minimize the impacts of this decision, including the implementation and continuation of existing environmental management programs, use of best management practices, and other specific mitigation measures. The majority of mitigation measures the Army has committed to in the ROD involve the continued use of existing management programs and existing best management practices. In addition to these existing programs, the Army and the National Historic Preservation Act Section 106 consulting parties have developed specific mitigation measures to minimize the adverse effects to the Ladd Field National Historic Landmark at FWA. These measures have been outlined and agreed to in a Programmatic Agreement between the Army and the Section 106 consulting parties.

The ROD outlines that Alternative 2 reflects the proper balance of enhancing USARAK aviation capabilities, improving training opportunities for existing USARAK forces, improving the Army's ability to support worldwide military operations, and protecting the environment.

Copies of the ROD can be viewed and downloaded at http://www.usarak.army.mil/conservation/NEPA_home.html .

Requests to make brief oral comments or provide written statements to the SPES should be sent to Jennifer Peyser at (202) 965-6215 or jpeyser@RESOLV.org. All requests must be received no later than November 24, 2009.

Meeting Access: For information on access or services for individuals with disabilities, please contact Jennifer Peyser at jpeyser@RESOLV.org. To request accommodation of a disability, please contact Jennifer Peyser at least 10 days prior to the meeting to give EPA as much time as possible to process your request.

Publication of the Performance Review Board (PRB) membership is required by 5 U.S.C. 4314(c)(4). The PRB reviews and evaluates the initial appraisal of a senior executive's performance by the supervisor, and makes written recommendations to the Acting Chairman of EEOC regarding performance ratings, performance awards, and pay-for-performance pay adjustments. The Board shall consist of at least three voting members. In the case of an appraisal of a career appointee, more than half of the members shall consist of career appointees, pursuant to 5 U.S.C. 4314(c)(5). The following individuals have been designated to serve on the Commission's Performance Review Board:

Primary Members: Lisa M. Williams, Chief Human Capital Officer, (Chair); Deidre M. Flippen, Director, Office of Research, Information and Planning; Danny G. Harter, Director, Indianapolis District Office; John Clarke Hendrickson, Senior Litigation Project Manager (Regional Attorney), Chicago District Office; Cynthia G. Pierre, PhD, Enforcement Director, U.S. Department of Education, Office of Civil Rights; Jocelyn Samuels, Senior Counselor to the Assistant Attorney General, Department of Justice, Civil Rights Division; and Thomas J. Schlageter, Director, Advice and External Litigation Division, Office of Legal Counsel.

Alternate: Mary Jo O'Neill, Regional Attorney, Phoenix District Office.

Title III of the Defense Production Act (DPA) of 1950 authorizes various forms of Government assistance to encourage expansion of production capacity and supply of industrial resources essential to national defense. The DPA Amendments of 1992 provide for the testing, qualification, and use of industrial resources manufactured or developed with assistance provided under Title III of the DPA.

FAR 34.1 and 52.234-1 require contractors, upon the direction of the contracting officer, to test Title III industrial resources for qualification, and provide the test results to the Defense Production Act Office. The FAR coverage also expresses Government policy to pay for such testing and provides definitions, procedures, and a contract clause to implement the policy. This information is used by the Defense Production Act Office, Title III Program, to determine whether the Title III industrial resource has been provided an impartial opportunity to qualify.

Respondents: 6.

Responses per Respondent: 3.

Total Annual Responses: 18.

Hours per Response: 100.

Total Burden Hours: 1,800.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (MVPR), 1800 F Street, NW., Room 4041, Washington, DC 20405, telephone (202) 501-4755. Please cite OMB Control Number 9000-0133, Defense Production Act Amendments, in all correspondence.

A. Purpose

FAR 30.6 and 52.230-5 include pertinent rules and regulations related to the Cost Accounting Standards along with necessary administrative policies and procedures. These administrative policies require certain contractors to submit cost impact estimates and descriptions in cost accounting practices and also to provide information on CAS-covered subcontractors.

Number of Respondents: 644.

Responses per Respondent: 2.27.

Total Responses: 1,462.

Average Burden Hours per Response: 200.85.

Total Burden Hours: 293,643.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (MVPR), 1800 F Street, NW., Room 4041, Washington, DC 20405, telephone (202) 501-4755. Please cite OMB Control No. 9000-0129, Cost Accounting Standards Administration, in all correspondence.

The Federal Acquisition Streamlining Act of 1994 included Title VIII, entitled Commercial Items. The title made numerous additions and revisions to both the civilian agency and Armed Service acquisition statutes to encourage and facilitate the acquisition of commercial items and services by Federal Government agencies.

To implement these changes, DOD, NASA, and GSA amended the Federal Acquisition Regulation (FAR) to include several streamlined and simplified clauses and provisions to be used in place of existing clauses and provisions. They were designed to simplify solicitations and contracts for commercial items.

Information is used by Federal agencies to facilitate the acquisition of commercial items and services.

Respondents: 37,500.

Responses per Respondent: 34.

Total Responses: 1,275,000.

Hours per Response: .312.

Total Burden Hours: 397,800.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (MVPR), 1800 F Street, NW., Room 4041, Washington, DC 20405, telephone (202) 501-4755. Please cite OMB Control No. 9000-0136, Commercial Item Acquisitions, in all correspondence.

A. Purpose

As prescribed in FAR 7.305(c), Right of First Refusal of Employment is a regulation which establishes policy regarding adversely affected or separated Government employees resulting from the conversion from in-house performance to performance by contract. The policy will enable these employees to have an opportunity to work for the contractor who is awarded the contract.

The information gathered will be used by the Government to gain knowledge of which employees, adversely affected or separated as a result of the contract award, have gained employment with the contractor within 90 days after contract performance begins.

Number of Respondents: 304.

Responses per Respondent: 1.

Total Responses: 304.

Average Burden Hours per Response: 3.

Total Burden Hours: 912.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (MVPR), 1800 F Street, NW., Room 4041, Washington, DC 20405, telephone (202) 501-4755. Please cite OMB Control Number 9000-0114, Right of First Refusal of Employment, in all correspondence.

Federal Acquisition Regulation (FAR) 52.203-7, Anti-Kickback Procedures, requires that all contractors have in place and follow reasonable procedures designed to prevent and detect in its own operations and direct business relationships, violations of section 3 of the Anti-Kickback Act of 1986 (41 U.S.C. 51-58). Whenever prime contractors or subcontractors have reasonable grounds to believe that a violation of section 3 of the Act may have occurred, they are required to report the possible violation in writing to the contracting agency or the Department of Justice. The information is used to determine if any violations of section 3 of the Act have occurred.

Respondents: 100.

Responses per Respondent: 1.

Annual Responses: 100.

Hours per Response: 1.

Total Burden Hours: 100.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (MVPR), 1800 F Street, NW., Room 4041, Washington, DC 20405, telephone (202) 501-4755. Please cite OMB Control No. 9000-0091, Anti-Kickback Procedures, in all correspondence.

In accordance with FAR the Contractor shall, within five days after work commences on the contract or another period of time determined by the Contracting Officer, prepare and submit to the Contracting Officer for approval three copies of a practicable schedule showing the order in which the Contractor proposes to perform the work, and the dates on which the Contractor contemplates starting and completing the several salient features of the work (including acquiring materials, plants, and equipment). The schedule shall be in the form of a progress chart of suitable scale to indicate appropriately the percentage of work scheduled for completion by any given date during the period. If the Contractor fails to submit a schedule within the time prescribes, the Contracting Officer may withhold approval of progress payments until the Contractor submits the required schedule.

Respondents: 2,600.

Responses per Respondent: 2.

Annual Responses: 5,200.

Hours per Response: 1.

Total Burden Hours: 5,200.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (MVPR), 1800 F Street, NW., Room 4041, Washington, DC 20405, telephone (202) 501-4755. Please cite OMB Control No. 9000-0058, Schedules for Construction Contracts, in all correspondence.

The clause requires the contractor to report a quarterly dollar value of all sales under the contract by calendar quarter. A separate report is required for each National Stock Number (NSN) or sub-item. The report is made electronically in accordance with the program office requirements. It is also used primarily by contracting officers to estimate requirements for the subsequent year, evaluate the effectiveness of a FSS contract, negotiate better prices based on volume and for special reports. The information is used primarily by contracting officers to estimate requirements for the subsequent year, evaluate the effectiveness of a schedule, negotiate better prices based on volume and for special reports.

Respondents: 17,000.

Responses per Respondent: 20.

Total Responses: 340,000.

Hours per Response: .0833.

Total Burden Hours: 28,322.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (MVPR), 1800 F Street, NW., Room 4041, Washington, DC 20405, telephone (202) 501-4755. Please cite OMB Control No. 3090-0121, Industrial Funding Fee and Sales Reporting, in all correspondence.

Under section 212(a)(1)(A)(ii) of the Immigration and Nationality Act (INA) (8 U.S.C. 1182(a)(1)(A)(ii)), any alien who seeks admission into the United States as an immigrant, or who seeks adjustment of status to the status of an alien lawfully admitted for permanent residence, is inadmissible into the United States if the alien is unable to present documentation of having received vaccination against “vaccine-preventable diseases, which shall include at least the following diseases: Mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus influenzae type B, and hepatitis B, and any other vaccinations against vaccine-preventable diseases recommended by the Advisory Committee on Immunization Practices.” Aliens subject to this provision may apply for a waiver in certain circumstances, e.g., if the vaccination is not medically appropriate or contrary to the alien's religious beliefs or moral convictions.

Medical examinations, including an evaluation to determine whether an alien has received these vaccinations, are authorized under section 232 of the INA (8 U.S.C. 1222). Under sections 212(a)(1) and 232 of the INA (8 U.S.C. 1182(a)(1), 1222), and section 325 of the Public Health Service Act (42 U.S.C. 252), the Department of Health and Human Services (HHS) publishes regulations establishing requirements for the medical examination. The Secretary of HHS has delegated the authority for administering these regulations to the Centers for Disease Control and Prevention (CDC). The regulations are codified in 42 CFR part 34. Panel physicians and civil surgeons, through contractual agreements and by designations with the Department of State (DOS) and the Department of Homeland Security (DHS), respectively, conduct the medical examinations in accordance with these regulations. CDC also publishes Technical Instructions (TIs) for the medical examinations, which must be followed by panel physicians and civil surgeons. The vaccinations required by the INA are listed in the Technical Instructions ( see http://www.cdc.gov/ncidod/dq/technica.htm ).

Since 1996, when the vaccination requirement was added to the INA, CDC has required immigrants subject to the INA vaccination requirement to receive all vaccinations routinely recommended by the Advisory Committee on Immunization Practices (ACIP) for the general U.S. population. Vaccine development has evolved since 1996 and, in addition, a greater number of vaccines are recommended by ACIP than were recommended when the legislation was enacted. As a result, CDC is reassessing which of these vaccinations are appropriate for immigration purposes, taking into consideration both the context in which they are given as well as the interests of public health.

To meet the threshold for consideration, a vaccine must first be an age-appropriate vaccine as recommended by the ACIP for the general U.S. population. After this determination is satisfied, the vaccine must protect against (1) a disease that has the potential to cause an outbreak, and/or (2) a disease that has been eliminated in the United States or is in the process for elimination in the United States. Outbreak is defined as the occurrence of more cases of disease than could be anticipated in a given area or among a specific group of people over a particular period of time. The determination of an outbreak may be made in a variety of scenarios. For example, an outbreak may be determined by comparing the current number of cases of disease with the background rate of the disease. The “background rate” of disease is the rate at which the disease usually occurs, at a particular time, in a particular population, or in a particular place. Therefore, the occurrence of a disease above the background rate, so that more people than usual or an unexpected group of people have become ill with the same disease in a given geographic area, or over a given period of time, could be viewed as an outbreak.

In general, and as observed through previous experience, an outbreak is associated with a public health response (e.g., initiation of an investigation, dissemination of prophylaxis, or public health messaging to change behavior).

CDC will also consider whether the disease has been eliminated in the United States or is in the process for elimination in the United States. “Elimination” is the reduction to zero of the incidence of infection caused by a specific agent in a defined geographic area as a result of deliberate public health efforts; continued measures to prevent re-establishment of transmission are required. 3 Therefore, if a vaccine is an age-appropriate vaccine as recommended by the ACIP for the general U.S. population, and the disease is in the process for elimination in the United States, it will be required for immigration purposes. The prevention of outbreaks and progress toward elimination represent two core public health goals. These criteria aim to prevent outbreaks and the re-introduction of vaccine-preventable diseases that have been eliminated or are in the process for elimination in the U.S. through the immunization of immigrants.

Congress mandated vaccinations for immigrants to decrease the public health threat from disease importation. Outbreak potential and absence of a vaccine-preventable disease in the United States (because of elimination or movement toward elimination through vaccination) are the critical public health concerns in determining which vaccines should be mandated for immigration to the United States. Evidence shows that disease importation contributes to many current vaccine-preventable disease outbreaks in the United States, and is solely responsible for outbreaks of eliminated diseases. For example, close to 90% of the measles cases reported in the U.S. during 2008 were either acquired abroad or linked to imported cases resulting in 7 outbreaks involving 135 persons. 4 Some of these cases are attributable to traveling unvaccinated U.S. citizens. Such disease vulnerability among U.S. citizens is beyond the scope of this notice and should be addressed by states and other public health authorities. The INA immigrant vaccination mandate, however, provides a significant opportunity to reduce the potential of disease importation, in particular of those diseases (1) where a single case has the potential to spread widely or (2) to threaten reintroduction of an eliminated disease.

Disease prevention vigilance at the borders through imposition of vaccination mandates focused on those diseases of outbreak or elimination significance serves a critical role in the multi-layered public health response to vaccine-preventable diseases. State vaccination mandates for school attendance and availability of vaccines for children through public health programs add other layers to that public health response. Working together, these layers result in vibrant vaccination coverage that protects the health of our citizens, individually and as a whole.

Further, it should be noted that given the existence of this multi-layered public health system for assuring adequate vaccination of all Americans, determination that a vaccine should not be mandated at time of immigration or change in status is not relevant to and should not in any way be considered a factor in determining whether or not that vaccine should be required for school entry or otherwise mandated by a state or other public health entity. Immunization mandates at various times and places are a highly important and effective public health tool for preventing vaccine-preventable diseases.

CDC has developed and accepted the criteria described in this Notice specifically for the required medical examination performed for U.S. immigration purposes. CDC stands behind all ACIP recommendations for the general U.S. population of which the immigrants will become part. CDC expects that such individuals will avail themselves of those vaccines not mandated for immigration as they make future wise medical decisions for themselves and encounter the other public health layers present to minimize vaccine-preventable diseases in our communities.

ACIP recommendations serve multifactorial purposes, including optimizing individual health status, protecting the public health of the Nation, and providing technical guidance for State-based mandates for school, child care, employment, and other settings. However, to date, the ACIP recommendations for the general U.S. population have been applied to aliens seeking admission into the United States without further consideration of the public health impact and need of these immunizations at the time of the medical examination for immigration. CDC believes specific public health criteria that focus on preventing infectious diseases that can cause outbreaks or are in the process of elimination should be used to determine which ACIP-recommended vaccinations for the U.S. population are appropriate to mandate for aliens seeking admission into the United States or seeking to adjust their status to that of lawful permanent resident at the time of the medical examination.

On April 8, 2009, CDC published a notice in the Federal Register seeking public comment on criteria CDC proposed to be used for these purposes. See 74 FR 15986. CDC proposed the following criteria:

1. The vaccine must be an age-appropriate vaccine, as recommended by ACIP for the general U.S. population, and

2. At least one of the following:

a. The vaccine must protect against a disease that has the potential to cause an outbreak. 5

b. The vaccine must protect against a disease that has been eliminated in the United States, or is in the process for elimination in the United States. 6

CDC received a total of forty (40) comments to the Federal Register notice, some of which contained multiple topics and some of which were the collaborative effort of multiple groups. Twenty-six comments were received regarding Human Papillomavirus (HPV) vaccine specifically, including two comments that suggested alternatives HHS/CDC could adopt if the HPV vaccine were not removed from the list as a result of the application of the adopted criteria. Twenty-four comments were received regarding HHS/CDC's current practice of requiring vaccines for the purpose of immigration. Nineteen comments were received that discussed the proposed criteria to be used in determining which vaccines recommended by ACIP for the U.S. population should be required for immigration purposes. Ten comments were received regarding the vaccine for the prevention of herpes zoster (zoster vaccine). Three comments were received regarding HHS/CDC's technical instructions. Finally, nine comments were received which were either outside the scope of the Notice or beyond the scope of HHS/CDC's mission. Below is a summary of public comments received and CDC's responses to those comments.

One commenter noted that the current requirements work very well in practice and wondered what might be accomplished by a change.

Response: The current process for determining which vaccines should be required does not take into consideration the purpose of the medical examination for U.S. immigration, i.e., to prevent the importation of infectious diseases of public health significance. The change to the current process will allow for the necessary flexibility to identify vaccines from a growing list of vaccines against vaccine-preventable diseases with highest public health impact (as defined in the criteria) at the time of the medical examination.

Some commenters asserted that CDC's current practice of listing all ACIP vaccines in its technical instructions is too broad and inflexible, and likely to lead to unnecessary requirements that do not allow immigrant women to make an informed decision about whether to obtain certain recommended vaccines.

Response: The issue of consent is not a subject of this notice. Congress has mandated (with opportunity for medical/religious/moral waiver) that particular vaccines be received by immigrants and that other vaccines also be received by them based on ACIP recommendations. Therefore, beyond application of waivers, immigrants do not have discretion to choose which mandated vaccines to receive.

Some commenters wondered why certain vaccines are required for immigrants and not U.S. citizens. Other commenters incorrectly assumed that the Federal Register Notice and proposed criteria applied to refugees.

Response: Vaccination requirements for aliens seeking admission into the United States are based on the Immigration and Nationality Act (INA). Section 212(a)(1)(A)(ii) of the INA requires any person who seeks admission as an immigrant, or who seeks adjustment of status to that of an alien lawfully admitted for permanent residence to document proof of vaccination of having received vaccination against certain vaccine-preventable diseases as listed in the statute or recommended by ACIP. The vaccine requirements provided in the INA do not apply to U.S. citizens. Additionally, the current vaccination requirements apply to refugees only when they apply to adjust their status to lawful permanent resident, typically one year after arrival into the United States.

Several commenters expressed concern that the DHS waiver for moral convictions or religious reasons is an ineffective tool because waiving all vaccinations for an individual—instead of waiving particular vaccinations—results in a completely unvaccinated individual and, therefore, a threat to public health. Further, not all immigrants are aware that such a waiver exists, or it may not be an option for them because they previously received vaccines.

Response: This issue is outside the scope of the request for comments—HHS does not issue waivers with respect to immigrant vaccination mandates. This is a function carried out by DHS under its regulations.

Some commenters agreed with the criteria and urged CDC to adopt them as proposed.

Response: CDC has adopted the criteria as proposed. Application of criteria to ACIP recommendations will begin thirty (30) days after publication of this Notice.

Some commenters expressed concern over the potential for an overly broad reading of proposed criterion 2b, which states: “is in the process for elimination in the United States.” These commenters suggested this text be narrowed to reflect an appropriate standard by which to evaluate the current and potential mandatory vaccinations for immigrants.

Response: CDC follows an accepted definition for elimination of infections that states: “Elimination is the reduction to zero of the incidence of infection caused by a specific agent in a defined geographic area as a result of deliberate efforts; continued measures to prevent re-establishment of transmission are required.”  7 Hence, in order to meet the criterion of an infection being in the process of elimination, deliberate efforts need to be in place for the elimination of infection, not merely the prevention of infection. CDC will rely on subject-matter experts, including national and international public health bodies such as the ACIP and the World Health Organization (WHO), to make such determinations. To date, only measles, polio, and rubella are considered to have been eliminated (or, in the case of polio, “eradicated”) in the United States.

One commenter raised concern that “potential to cause an outbreak,” as defined in the April 8, 2009 Federal Register Notice, is vague and overly broad and could be used to make a specious case that it encompasses noninfectious diseases. HPV, which can lead to cancer, is currently the most common sexually transmitted disease in the United States, which could be interpreted as being “an outbreak.” This commenter suggested that the definition of outbreak should be narrowed to include the spread of disease through the respiratory route or common public contact, and should also reference the difficulty of containing the spread due to unavoidable exposure.

Response: CDC is adopting the language provided for in the Federal Register notice because it is widely established and accepted in public health. CDC recognizes that the mode of transmission itself does not define an outbreak potential. Similarly, as discussed in the Background section above, high prevalence in and of itself does not constitute an outbreak—in that it does not automatically mean there are “more cases of disease than could be anticipated in a given area or among a specific group of people over a particular period of time” per the applied definition of an outbreak. For endemic diseases, an outbreak occurs when the incidence rises above the normal expected level. While HPV is a common infection, the occurrence of more cases than expected (as defined by an outbreak, discussed above) is not met. Further, HPV has not been eliminated, nor is in the process of elimination, in the United States. Therefore, because HPV does not meet the adopted criteria, it will not be a required vaccine for immigrant and adjustment of status to permanent residence applicants.

Some commenters rejected the proposed criteria and developed a list of vaccinations which should be required based upon their personal beliefs or practices.

Response: Commenters should be aware that not all vaccination requirements are subject to change as a result of the adoption of these criteria. For example, vaccinations are not required for any alien for whom a civil surgeon, medical officer, or panel physician certifies that the vaccination would not be medically appropriate or for whom the vaccination requirement would be contrary to religious beliefs or moral convictions, in accordance with regulations promulgated by DHS. Further, commenters should be aware that most adopted children 10 years of age or younger are not required to receive such vaccinations provided certain requirements are met. This includes a requirement that, prior to the admission of the child, an adoptive or prospective adoptive parent of the child who has sponsored the child for admission as an immediate relative must execute an affidavit stating that the parent is aware of the vaccination requirements and will ensure that the child receives the required vaccinations within 30 days of the child's admission, or earlier if medically appropriate.

CDC received numerous comments both advocating for and against inclusion of HPV vaccine.

Response: CDC has applied the criteria and determined that once these criteria become effective December 14, 2009, the HPV vaccine will not be required for aliens seeking admission as an immigrant or seeking adjustment of status to that of an alien lawfully admitted for permanent residence. In reaching this decision, CDC applied the adopted criteria. Genital infection with HPV is an extremely common infection due to its efficient transmission via sexual intercourse. There are approximately 6 million incident infections occurring annually in the United States. Over half of sexually active men and women will develop HPV infection at some point in their lives and 15% of all Americans have current infection with HPV. 8 Even more individuals will have been infected previously in their lives.

Although millions of HPV infections occur annually, most are asymptomatic and resolve. About 10,000 cases of cervical cancer (the most important biologic outcome of HPV infection) develop annually in the United States. Because HPV infection is common in the general US population, is asymptomatic, and because it is not possible to distinguish infections which resolve spontaneously from those that result in cervical cancer, HPV is not the target of outbreak control. Rather a routine vaccination program is recommended to prevent infection. Similarly, HPV is not the target of a disease elimination campaign in the United States.

Therefore, while HPV may be an age-appropriate vaccine for an immigrant applicant, HPV neither causes outbreaks nor is it associated with outbreaks (per explanation in the background section). Further, HPV has not been eliminated, nor is in the process of elimination, in the United States. Therefore, because HPV does not meet the adopted criteria, it will not be a required vaccine for immigrant and adjustment of status to permanent residence applicants.

One commenter asked CDC to clarify if the phrase “through 26 years of age,” as written in the Technical Instructions for administration of the HPV vaccine, means “past the age of 26 and up to 27,” or “up to the age of 26.”

Response: CDC clarifies that “through 26 years of age” means past the age of 26 and up to the 27th birthday.

One commenter suggested that if, as a result of these published criteria, the HPV vaccine is not removed from the list of required vaccinations, aliens should be allowed to forego a required vaccination on the basis that it protects against a noninfectious disease. Further, that commenter asserted that there should be no charge or application for opting out of such vaccines, and the Attorney General should not have the discretion to deny aliens this option.

Response: As indicated above, when the newly adopted criteria become effective (30 days after publication of this Notice), the HPV vaccine will no longer be required for immigration purposes. For those vaccines mandated for immigration, the only basis for opting out is receipt of a medical, religious, or moral convictions waiver. Whether or not the Attorney General has the authority to require a fee or application as part of a waiver process for vaccinations, is beyond the scope of this Notice.

One commenter requested CDC to direct the ACIP to modify its recommendation to state that the HPV vaccination should not be mandated for immigrants.

Response: The nature of an advisory committee is to provide its independent, unfettered expertise and advice to the agency, as described in the committee's administrative charter. The agency does not mandate that it receive any particular advice.

One commenter urged CDC to direct the U.S. Citizenship and Immigration Services agency (USCIS) to suspend the HPV vaccination requirement for immigrants applying to adjust their immigration status or obtain visas for the United States.

Response: HHS/CDC has no authority to direct component agencies within DHS to take action. However, HHS/CDC has determined that the HPV vaccine does not meet the necessary elements of the proposed criteria and will no longer be required for immigration purposes once the criteria become effective (30 days after publication of this notice).

Several commenters opposed the requirement of Zoster vaccine based upon the proposed criteria, and further found the costs to immigrants and refugees for this vaccine to be prohibitive.

Response: Upon application of the criteria adopted in this final notice, CDC has determined that Zoster vaccine will no longer be required for immigration purposes once the criteria become effective (30 days after publication of this notice). In reaching this decision, CDC applied the adopted criteria. Varicella Zoster Virus (VZV) is an exclusively human pathogen that infects approximately 98% of the adult population in the United States. 9 Approximately 1 million new cases of Zoster occur in the United States annually and approximately one in three persons in the general population will develop zoster during their lifetime. These statistics alone indicate that VZV has neither been eliminated, nor is in the process of elimination in the United States. 10 Further, Zoster neither causes outbreaks nor is it associated with outbreaks of varicella: Its high prevalence in the U.S. is in keeping with the background rate of the disease (i.e., no more people than usual, or an unexpected group of people, have become ill with VZV in a given geographic area in the U.S. over a given period of time). Therefore, because Zoster does not meet the criteria, it will not be a required vaccine for immigrant and adjustment of status to permanent residence applicants.

One commenter requested that state immunization programs be notified of any change in vaccination requirements.

Response: Any changes in the vaccination requirements for immigrant visa and adjustment of status applicants are posted on the CDC and DHS (USCIS) Web sites. Thus, they are available to the public and all organizations (e.g., civil surgeons, health departments) involved in vaccination issues.

One commenter requested that the Technical Instructions be updated to reflect any change in vaccination requirements.

Response: The Technical Instructions are routinely revised to reflect needed changes (e.g., addition of new vaccines). Two key changes to the Technical Instructions are based on the adoption of the criteria in this Federal Register Notice, i.e., that neither the HPV nor Zoster vaccines be required as part of the medical examination. These changes, which become effective 30 days after publication of this notice, will be reflected in the revised Technical Instructions posted on the CDC Web site at http://www.cdc.gov/ncidod/dq/technica.htm.

One commenter suggested that the current Technical Instructions do not follow the ACIP recommendations and are confusing regarding the age-appropriate vaccinations and minimum intervals.

Response: The current Technical Instructions are based on age-appropriate vaccinations and minimum intervals of vaccine doses provided by the ACIP recommendations for the general population. The vaccine tables for children and adults based on the ACIP recommendations are located on CDC's Web site at the following Internet address: http://www.cdc.gov/vaccines/recs/schedules/.

One commenter requested that the Technical Instructions be reviewed (if not written) by the National Center for Immunization and Respiratory Diseases (NCIRD) staff who are very familiar with immunizations.

Response: The Technical Instructions are developed in coordination with numerous components of CDC, including NCIRD and other programs with expertise in immunization matters. Following their development, the Technical Instructions then undergo official agency clearance, which also includes review by relevant components of the agency. Ultimately, the Technical Instructions are published by CDC's Division of Global Migration and Quarantine (DGMQ), which is the component of CDC responsible for administering them for use by civil surgeons and panel physicians.

One commenter called attention to the incorrect deadline for submission of comments which was originally posted in the Federal Register Notice.

Response: CDC appreciates this comment and had already made changes to the original notice and published the corrected date on April 20, 2009 in the Federal Register (74 FR 17966) to accurately reflect 30 days after the April 8, 2009, publication.

Another commenter urged the CDC to halt all immigration to the United States, thus making the vaccination issue moot.

Response: Immigration laws are promulgated by the U.S. Congress and implemented by DHS. While CDC administers regulations describing medical examinations that aliens must undergo, as described above, CDC has no authority over immigration matters.

Commenters requested that all people immigrating to the United States receive all available vaccinations to protect the U.S. public health.

Response: The current vaccination requirements are based on the Immigration and Nationality Act, which requires any person who seeks an immigrant visa or who applies for adjustment of status to lawful permanent resident to have certain specified vaccines, as well as those recommended by ACIP. CDC has adopted criteria for determining which of the vaccinations recommended by ACIP are appropriate for the immigration population, in order to take into consideration the highest public health impact as defined in the criteria at the time of the medical examination for U.S. immigration.

One commenter suggested that, rather than seek public comment on which vaccinations should be required for immigration purposes, CDC should focus on the connection between vaccines and autism.

Response: HHS has a statutory obligation to describe medical examinations certain aliens must undergo. This responsibility has been delegated to CDC/DGMQ. This notice is being implemented under that authority. While HHS/CDC does work on the subject of autism, it is outside the scope of this notice.

After consideration of public comments received through this notice, as well as those received during an ACIP meeting held at CDC February 25-26, 2009, CDC is adopting the criteria as proposed and will begin applying the criteria to determine which vaccines recommended by ACIP for the general U.S. population will be required (in addition to those statutorily mandated) for immigrants in accordance with section 212(a)(1)(A)(ii) of the Immigration and Nationality Act, 8 U.S.C. 1182(a)(1)(A)(ii)). The current vaccine tables for children and adults based on the ACIP recommendations for the U.S. population are located on CDC's Web site at: http://www.cdc.gov/vaccines/recs/schedules/.

The criteria that CDC is adopting today and will apply 30 days after publication of this notice are as follows:

1. The vaccine must be an age-appropriate vaccine as recommended by the ACIP for the general U.S. population, and

2. At least one of the following:

a. The vaccine must protect against a disease that has the potential to cause an outbreak. 11

b. The vaccine must protect against a disease that has been eliminated in the United States or is in the process for elimination in the United States. 12

The updated vaccination requirements will be listed in the Technical Instructions (see http://www.cdc.gov/ncidod/dq/technica.htm ) and will become effective 30 days after publication of this notice. CDC will continue to require the vaccinations explicitly referenced in section 212(a)(1)(A)(ii): Mumps, measles, rubella, polio, Tetanus and diphtheria toxoids, pertussis, Haemophilus influenzae type B and hepatitis B). All vaccines will remain subject to statutory waivers, if applicable. CDC will periodically review the list of vaccines recommended by ACIP for the general U.S. population to determine whether additional vaccinations fall within CDC's recommended criteria. Any changes to the list of required vaccines, which result from an application of these criteria, will be reflected in CDC's Technical Instructions, available to the public at http://www.cdc.gov/ncidod/dq/technica.htm ). If there is a future need for CDC to reconsider these established criteria, CDC will solicit comments through publication in the Federal Register.

Section 306(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 335a(a)(2)(B)) requires debarment of an individual if FDA finds that the individual has been convicted of a felony under Federal law for conduct otherwise relating to the regulation of any drug product under the act.

On January 4, 2006, the U.S. District Court for the District of Minnesota entered judgment against Michelle L. Torgerson for one count of misbranding a drug, a federal felony offense under sections 301(k), 303(a)(2), and 352(b)(1) (21 U.S.C. 331(k), 333(a)(2), and 353(b)(1)), after accepting her guilty plea on May 19, 2005. This offense was committed when Michelle L. Torgerson was employed as a nurse by Maxim Health Systems in the State of Minnesota. During that time, Ms. Torgerson conducted unauthorized flu vaccination clinics on the campus of Augsburg College, without the approval of her employer, Maxim Health Systems. Ms. Torgerson also falsely represented that the American Heart Association was sponsoring or otherwise authorizing the clinics. Michelle L. Torgerson acknowledged that, in conducting the unauthorized clinics, she acted with the intent to defraud and mislead the public and that she caused a quantity of a prescription drug, namely, the flu virus vaccine Fluzone®, to be misbranded within the meaning of 21 U.S.C. 353(b)(1), while the flu virus vaccine was being held for sale after being shipped in interstate commerce. Specifically, Ms. Torgerson acknowledged that she dispensed the flu virus vaccine without a written prescription of a practitioner licensed by law to administer the flu virus vaccine. Ms. Torgerson knew that, as a Licensed Practical Nurse, she was not authorized to dispense the flu virus vaccine without a physician's orders. She also acknowledged that she diluted some of the vaccine with saline knowing that this would reduce the flu vaccine's quality and strength.

As a result of this conviction, FDA sent Ms. Torgerson by certified mail on August 7, 2009, a notice proposing to permanently debar her from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(a)(2)(B) of the act that Michelle L. Torgerson was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. The proposal also offered Ms. Torgerson an opportunity to request a hearing, providing her 30 days from the date of receipt of the letter in which to file the request, and advised her that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Ms. Torgerson failed to respond within the timeframe prescribed by regulation and has, therefore, waived her opportunity for a hearing and any contentions concerning her debarment (21 CFR part 12).

Therefore, the Acting Director, Office of Enforcement, Office of Regulatory Affairs, under section 306(a)(2)(B) of the act, and under authority delegated to the Acting Director (Staff Manual Guide 1410.35), finds that Michelle L. Torgerson has been convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act.

As a result of the foregoing finding, Ms. Torgerson is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES ) (see sections 306(c)(1)(B), 306(c)(2)(A)(ii), and 201(dd) of the act (21 U.S.C.321(dd)). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of Michelle L. Torgerson, in any capacity, during Ms. Torgerson's permanent debarment, will be subject to civil money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6)). If Ms. Torgerson, during her period of debarment, provides services in any capacity to a person with an approved or pending drug product application, she will be subject to civil money penalties (section 307(a)(7) of the act). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Ms. Torgerson during her period of debarment (section 306(c)(1)(B) of the act).

Any application by Ms. Torgerson for special termination of debarment under section 306(d)(4) of the act should be identified with Docket No. FDA-2009-N-0292 and sent to the Division of Dockets Management (see ADDRESSES ). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j).

Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

In the Federal Register of September 12, 2008 (73 FR 53028), FDA published a notice announcing the opening of a public docket to receive information and comments on the post market experience associated with the use of laser-assisted in situ keratomileusis (LASIK) devices, as well as information regarding potential barriers that may exist in providing the agency with feedback regarding LASIK procedures. Interested persons were invited to submit comments by September 14, 2009. At this time, the agency is reopening the docket to continue to receive public comments. Information and comments submitted to the docket will assist us in identifying ways in which we can improve our public outreach efforts regarding the safety and effectiveness of LASIK devices.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) electronic or written comments regarding 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. All comments submitted to the public docket are public information and may be posted to the FDA's Web site at http://www.fda.gov for public viewing. 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.

This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the

Information collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

This notice also lists the following information:

Title of Proposal: Request for Approval of Advance of Escrow Funds.

OMB Approval Number: 2502-0018.

Form Numbers: HUD-92464.

Description of the Need for the Information and Its Proposed Use: The Department requires mortgagors/borrowers and mortgagee/Lenders to execute a Building Loan Agreement setting forth terms and conditions under which progress payments may be advanced during project construction. The Agreement is executed before initial endorsement of mortgage insurance. HUD-92464 is a document used for assurance of completion for escrowed funds.

Frequency of Submission: On occasion.

Total Estimated Burden Hours: 1,872.

Status: Extension of a currently approved collection.

This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the Information collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

This notice also lists the following information:

Title of Proposal: Direct Endorsement Underwriter/HUD Reviewer-Analysis of Appraisal Report.

OMB Approval Number: 2502-0477.

Form Numbers: HUD-54114.

Description of the Need for the Information and Its Proposed Use: The information collection is used to capture information on appraisal reports considered deficient by the underwriter, and to document efforts to resolve any discrepancies. The basic respondents are lender underwriters.

Frequency of Submission: On occasion.

Total Estimated Burden Hours: 27,916.

Status: Extension of a currently approved collection.

This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the Information collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

This notice also lists the following information:

Title of Proposal: Debt Resolution Program.

OMB Approval Number: 2502-0483.

Form Numbers: HUD-56141, HUD-56142, HUD-56146 and HUD-92090.

Description of the Need for the Information and Its Proposed Use:

HUD is required to collect debt owed to the agency. As part of the collection process, demand for repayment is made on the debtor(s). In response, debtors opt to ignore the debt, pay the debt or dispute the debt. Disputes and offers to repay the debt result in information collections. Borrowers who wish to pay less than the full amount due must submit a Personal Financial Statement Offer. HUD uses the information to analyze debtors' financial positions and then approve settlements, repayment agreements, and pre-authorized electronic payments to HUD. Borrowers who wish to dispute must provide information to support their position.

Frequency of Submission: On occasion.

Total Estimated Burden Hours: 854.

Status: Extension of a currently approved collection.

This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the Information collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

This notice also lists the following information:

Title of Proposal: Technical Processing Requirements for Multifamily Project Mortgage Insurance.

OMB Approval Number: 2502-0500.

Form Numbers: HUD-2415, HUD-2456, HUD-92466, HUD-2283, FHA-2455, FHA-1710, HUD-92433, HUD-92450, HUD-92443, FHA-2459 HUD-3305, HUD-3306, HUD-92403.1

Description of the Need for the Information and Its Proposed Use: This information is collected form mortgagees, mortgagors, contractors, and attorneys for the purpose of obtaining multifamily mortgage insurance for new or rehabilitated housing. The information collected is used to determine if key principals are acceptable and have the ability to manage the development, construction, completion, and successful lease-up of the proposed property.

Frequency of Submission: Other required with each project application.

Total Estimated Burden Hours: 11,050.

Status: Reinstatement, with change, of prevision of approved collection.

Authority: Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 35, as amended.

This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the Information collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

This notice also lists the following information:

Title of Proposal: Standardized form for “Race and Ethnic Data Collection”.

OMB Approval Number: 2535-0113.

Form Numbers: HUD-27061.

Description of the Need for the Information and Its Proposed Use: All HUD program offices use this form when collecting information concerning the race and ethnicity of the populations intended to benefit from HUD funding as required by Title VI of the Civil Rights Act of 1964.

Frequency of Submission: On occasion, quarterly, annually.

Total Estimated Burden Hours: 1

Status: Extension of a currently approved collection.

Authority: Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 35, as amended.

This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the

Information collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

This notice also lists the following information:

Title of Proposal: Contract and Subcontract Activity Reporting on Minority Business Enterprise (MBE).

OMB Approval Number: 2535-0117.

Form Numbers: HUD-2516.

Description of the Need for the Information and Its Proposed Use: The information is collected from developers, borrowers, sponsors, or project managers. Summaries from this report enable HUD to monitor and evaluate progress toward designated Minority Business Enterprise (MBE) goals of Executive Order 12432. The information is used for the Department's annual report.

Frequency of Submission: Annually.

Total Estimated Burden Hours: 5,901.

Status: Extension of a currently approved collection.