Notices. Notice

8,634 words·~39 min read·/register/2007/03/28/07-1498

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4160-18-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Public Comment on the Proposed Adoption of ANA Program Policies and Procedures; Correction AGENCY: Administration for Native Americans

(ANA)ACTION: Notice. SUMMARY: Pursuant to section 814 of the Native American Programs Act of 1974 (the Act) 42 U.S.C. 2992b-1, ANA herein describes its proposed interpretive rules, statements of general policy and rules of agency procedure or practice in relation to the Social and Economic Development Strategies (hereinafter referred to as SEDS), Native Language Preservation and Maintenance (hereinafter referred to as Native Language), Environmental Regulatory Enhancement (hereinafter referred to as Environmental), Environmental Mitigation (hereinafter referred to as Mitigation), Improving the Well-Being of Children—Native American Healthy Marriage Initiative (hereinafter referred to as Healthy Marriage) programs and any Special Initiatives. Under the statute, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, statements of general policy and rules of agency procedure or practice and to give notice of the final adoption of such changes at least thirty

(30)days before the changes become effective. This Notice also provides additional information about ANA's plan for administering the programs. On July 18, 2005, ANA published a Notice of Public Comment

(NOPC)in the **Federal Register** (Vol. 70, No. 136) announcing an administrative policy change on the number of awards an eligible applicant could receive under the SEDS program, Catalog of Federal Domestic Assistance number 93.612. This change only affected the Healthy Marriage program. On November 21, 2006, ANA published the annual NOPC in the **Federal Register** (Vol. 71, No. 224), which did not include a necessary correction to the revised administrative policy published on July 18, 2005. On December 22, 2006, ANA published a third **Federal Register** notice (Vol. 71, No. 246) to clarify the revised administrative policy published on July 18, 2005, on the number of awards an eligible applicant could receive under the SEDS program, Catalog of Federal Domestic Assistance number 93.612. ANA received three responses to the December 22, 2006, NOPC clarification. After review and consideration of the comments received, ANA determined that the administrative policy originally published on July 18, 2005, required clarification and revision. This Notice clarifies the agency's intent and provides a definitive statement on the number of awards an eligible applicant can receive under the Catalog of Federal Domestic Assistance number 93.612. FOR FURTHER INFORMATION CONTACT: Sheila K. Cooper, Director of Program Operations, toll-free at

(877)922-9262. *Additional Information:* The following statement corrects previous notices: VI. ANA Administrative Policy Change In the July 18, 2005, **Federal Register** (Vol. 70, No. 136), ANA made an administrative policy change that eligible applicants applying for funding under ANA's healthy marriage special initiative under Catalog of Federal Domestic Assistance number 93.612, would not be held to the long-standing ANA policy: “An applicant can have only one active Social and Economic Development Strategies

(SEDS)grant operating at any given time.” On December 22, 2006, ANA published notice that ANA was clarifying its policy pertaining to funding under the SEDS program. The **Federal Register** notice (Vol. 71, No. 246) stated that ANA was “reinforcing the policy that applicants may submit only one application for SEDS or one application for NAHMI but not for both.” Three public comments were received in response to the notice. All of the comments stated that Native communities experience tremendous needs and Tribes and Native Organizations plan and target their requests for financial assistance, and requested that ANA allow multiple awards under Catalog of Federal Domestic Assistance number 93.612. After review and further consideration of the comments, an analysis of the annual requests for funding, which far exceed the funding amount available, and review of the award distribution among applicants for ANA funding, it is necessary that ANA issue this Notice applying to the Healthy Marriage program ANA's long-standing policy that applicants may only receive one award at any one time under Catalog of Federal Domestic Assistance number 93.612. Therefore, applicants may submit only one application for project funding under the SEDS program or one application for project funding under NAHMI, but not for both. Dated: February 26, 2007. Sheila Cooper, Director of the Division of Program Operations, Administration for Native Americans. [FR Doc. E7-5630 Filed 3-27-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families State Median Income Estimate for a Four-Person Family: Notice of the Federal Fiscal Year

(FFY)2008 State Median Income Estimates for Use Under the Low Income Home Energy Assistance Program (LIHEAP), Administered by the U.S. Department of Health and Human Services (HHS), Administration for Children and Families, Office of Community Services, Division of Energy Assistance AGENCY: Administration for Children and Families, Office of Community Services, Division of Energy Assistance, HHS. ACTION: Notice of estimated State median income estimates for FFY 2008. SUMMARY: This notice announces the estimated median income for four-person families in each State and the District of Columbia for FFY 2008 (October 1, 2007 to September 30, 2008). LIHEAP grantees may adopt the State median income estimates beginning with the date of publication in the **Federal Register** or at a later date as discussed below. This enables LIHEAP grantees to choose to implement this notice during the period between the heating and cooling seasons. However, by October 1, 2007, or the beginning of a grantee's fiscal year, whichever is later, LIHEAP grantees using State median income estimates must adjust their income eligibility criteria to be in accord with the FFY 2008 State median income estimates. This listing of estimated State median incomes provides one of the maximum income criteria that LIHEAP grantees may use in determining a household's income eligibility for LIHEAP. DATES: *Effective Date:* The estimates are effective at any time between the date of this publication and October 1, 2007, or until the beginning of a LIHEAP grantee's fiscal year, whichever is later. FOR FURTHER INFORMATION CONTACT: Peter Edelman, Office of Community Services, Division of Energy Assistance, 5th Floor West, 370 L'Enfant Promenade, SW., Washington, DC 20447, Telephone:

(202)401-5292, E-Mail: *peter.edelman@acf.hhs.gov.* SUPPLEMENTARY INFORMATION: Under the provisions of section 2603(11) of Title XXVI of the Omnibus Budget Reconciliation Act of 1981, Public Law

(PL)97-35, as amended, HHS announces the estimated median income of a four-person family for each State, the District of Columbia, and the United States for FFY 2008 (October 1, 2007, through September 30, 2008). Section 2605(b)(2)(B)(ii) of the LIHEAP statute provides that 60 percent of the median income for each State, as annually established by the Secretary of the Department of Health and Human Services, is one of the income criteria that LIHEAP grantees may use in determining a household's eligibility for LIHEAP. LIHEAP is authorized through the end of FFY 2008 by the Energy Policy Act of 2005, PL 109-58, enacted on August 8, 2005. Estimates of the median income for a four-person family for each State and the District of Columbia for FFY 2008 are produced by the Census Bureau of the U.S. Department of Commerce, using the most recently available income data. In previous years, model-based estimates of the median income for a four-person family used the following data sources:

(1)The Current Population Survey's Annual Social and Economic Supplement File;

(2)the 2000 Decennial Census of Population; and

(3)per capita personal income estimates, by State, from the Bureau of Economic Analysis

(BEA)of the U.S. Department of Commerce. In preparing State-level, four-person family median income estimates for FFY 2008, the Census Bureau revised its methodology. The Census Bureau chose to use direct estimates derived from the American Community Survey

(ACS)instead of using the model-based estimates. Generally, this change decreased, on average, State median income estimates by about 0.8 percent compared to the model-based estimates. There are two key advantages in using the ACS over the previous methodology. First, as the Federal Government's largest current household survey (approximately 3 million addresses per year), the ACS is able to produce State-level estimates with very low sampling errors. Second, since it is possible to obtain reliable State income estimates directly from the ACS (as opposed to the previous methodology that used a model based on several data sources), ACS estimates will be available on a more timely basis. For example, the ACS 2005 State median income estimates were released by the Census Bureau in August 2006. Information about the ACS is available at *http://www.census.gov/acs/www/.* For further information on the ACS State median income estimates, contact the Housing and Household Economic Statistics Division, at the Census Bureau

(301)763-3243. A State-by-State listing of median income and 60 percent of median income for a four-person family for FFY 2008 follows. The listing describes the method for adjusting median income for families of different sizes as specified in regulations applicable to LIHEAP, at 45 CFR 96.85(b), published in the **Federal Register** on March 3, 1988 at 53 FR 6824. Dated: March 21, 2007. Yolanda Butler, Deputy Director, Office of Community Services. Estimated State Median Income for a Four-Person Family, by State, Federal Fiscal Year

(FFY)2008 1 States Estimated State median income for a four-person family 2 60 percent of estimated State median income for a four-person family Alabama $53,690 $32,214 Alaska 76,560 45,936 Arizona 61,102 36,661 Arkansas 52,217 31,330 California 70,712 42,427 Colorado 70,300 42,180 Connecticut 92,205 55,323 Delaware 76,288 45,773 District of Columbia 50,248 30,149 Florida 62,269 37,361 Georgia 64,427 38,656 Hawaii 79,240 47,544 Idaho 52,470 31,482 Illinois 72,368 43,421 Indiana 64,564 38,738 Iowa 65,575 39,345 Kansas 64,929 38,957 Kentucky 54,992 32,995 Louisiana 55,945 33,567 Maine 64,806 38,884 Maryland 89,608 53,765 Massachusetts 85,420 51,252 Michigan 71,542 42,925 Minnesota 77,395 46,437 Mississippi 47,726 28,636 Missouri 63,847 38,308 Montana 55,641 33,385 Nebraska 64,800 38,880 Nevada 61,777 37,066 New Hampshire 81,522 48,913 New Jersey 90,261 54,157 New Mexico 48,223 28,934 New York 72,170 43,302 North Carolina 59,481 35,689 North Dakota 59,926 35,956 Ohio 66,734 40,040 Oklahoma 53,138 31,883 Oregon 61,945 37,167 Pennsylvania 68,646 41,188 Rhode Island 78,297 46,978 South Carolina 57,932 34,759 South Dakota 61,309 36,785 Tennessee 56,874 34,124 Texas 57,511 34,507 Utah 57,999 34,799 Vermont 71,382 42,829 Virginia 77,430 46,458 Washington 72,103 43,262 West Virginia 52,292 31,375 Wisconsin 71,064 42,638 Wyoming 62,933 37,760 Note: FFY 2008 covers the period of October 1, 2007 through September 30, 2008. The estimated median income for a four-person family living in the United States is $67,019 for FFY 2008. The estimates are effective for the Low Income Home Energy Assistance Program (LIHEAP) at any time between the date of this publication and October 1, 2007, or by the beginning of a LIHEAP grantee's fiscal year, whichever is later. 1 In accordance with 45 CFR 96.85, each State's estimated median income for a four-person family is multiplied by the following percentages to adjust for family size for LIHEAP: 52 percent for one person, 68 percent for two persons, 84 percent for three persons, 100 percent for four persons, 116 percent for five persons, and 132 percent for six persons. For each additional family member above six persons, add 3 percentage points to the percentage for a six-person family (132 percent), and multiply the new percentage by the State's estimated median income for a four-person family. 2 Prepared by the Census Bureau from the 2005 American Community Survey. For further information, contact the Housing and Household Economic Statistics Division at the Census Bureau (301-763-3243). [FR Doc. E7-5631 Filed 3-27-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0091] Agency Information Collection Activities; Proposed Collection; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions in the guidance document entitled “Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition.” DATES: Submit written or electronic comments on the collection of information by May 29, 2007. ADDRESSES: Submit electronic comments on the collection of information to: http://www.fda.gov/dockets/ecomments. Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA'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 respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition (OMB Control Number 0910-0541)—Extension As an integral part of its decisionmaking process, FDA is obligated under the National Environmental Policy Act of 1969

(NEPA)to consider the environmental impact of its actions, including allowing notifications for food contact substances to become effective and approving food additive petitions, color additive petitions, GRAS affirmation petitions, requests for exemption from regulation as a food additive, and actions on certain food labeling citizen petitions, nutrient content claims petitions, and health claims petitions. In 1997, FDA amended its regulations in part 25 (21 CFR part 25) to provide for categorical exclusions for additional classes of actions that do not individually or cumulatively have a significant effect on the human environment (62 FR 40570, July 29, 1997). As a result of that rulemaking, FDA no longer routinely requires submission of information about the manufacturing and production of FDA-regulated articles. FDA also has eliminated the previously required Environmental Assessment

(EA)and abbreviated EA formats from the amended regulations. Instead, FDA has provided guidance that contains sample formats to help industry submit a claim of categorical exclusion or an EA to CFSAN. The guidance document entitled “Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition” identifies, interprets, and clarifies existing requirements imposed by statute and regulation, consistent with the Council on Environmental Quality regulations (40 CFR 1507.3). It consists of recommendations that do not themselves create requirements; rather, they are explanatory guidance for FDA's own procedures in order to ensure full compliance with the purposes and provisions of NEPA. The guidance provides information to assist in the preparation of claims of categorical exclusion and EAs for submission to CFSAN. The following questions are covered in this guidance:

(1)What types of industry-initiated actions are subject to a claim of categorical exclusion?

(2)What must a claim of categorical exclusion include by regulation?

(3)What is an EA?

(4)When is an EA required by regulation and what format should be used?

(5)What are extraordinary circumstances? and

(6)What suggestions does CFSAN have for preparing an EA? Although CFSAN encourages industry to use the EA formats described in the guidance because standardized documentation submitted by industry increases the efficiency of the review process, alternative approaches may be used if these approaches satisfy the requirements of the applicable statutes and regulations. FDA is requesting the extension of OMB approval for the information collection provisions in the guidance. *Description of Respondents* : The likely respondents include businesses engaged in the manufacture or sale of food, food ingredients, and substances used in materials that come into contact with food. FDA estimates the burden of this collection of information as follows: ** Table 1.—Estimated Annual Reporting Burden 1 ** 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Burden Hours 25.32(i) 52 3 156 1 156 25.32(o) 1 1 1 1 1 25.32(q) 7 2 14 1 14 Total 171 171 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The above estimates for respondents and numbers of responses are based on the annualized numbers of petitions and notifications qualifying for § 25.32(i) and

(q)that the agency has received in the past 3 years. Please note that, in the past 3 years, there have been no submissions that requested an action that would have been subject to the categorical exclusion in § 25.32(o). To avoid counting this burden as zero, FDA has estimated the burden for this categorical exclusion at one respondent making one submission a year for a total of one annual submission. To calculate the estimate for the hours per response values, we assumed that the information requested in this guidance for each of these three categorical exclusions is readily available to the submitter. For the information requested for the exclusion in § 25.32(i), we expect that submitter will need to gather information from appropriate persons in the submitter's company and to prepare this information for attachment to the claim for categorical exclusion. We believe that this effort should take no longer than 1 hour per submission. For the information requested for the exclusions in § 25.32(o) and (q), the submitters will almost always merely need to copy existing documentation and attach it to the claim for categorical exclusion. We believe that collecting this information should also take no longer than 1 hour per submission. Dated: March 22, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-5634 Filed 3-27-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2003E-0243 and 2003E-0244] Determination of Regulatory Review Period for Purposes of Patent Extension; INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of two applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that medical device. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA recently approved for marketing the medical device INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE. INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease

(DDD)at one level from L4—S1. Subsequent to this approval, the Patent and Trademark Office received two patent term restoration applications for INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (U.S. Patent Nos. 5,782,919 and 5,984,967)) from SDGI Holdings, Inc., and the Patent and Trademark Office requested FDA's assistance in determining these patents' eligibility for patent term restoration. In a letter dated April 6, 2004, FDA advised the Patent and Trademark Office that this medical device had undergone a regulatory review period and that the approval of INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE is 2,052 days. Of this time, 1,515 days occurred during the testing phase of the regulatory review period, while 537 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this device became effective* : November 20, 1996. FDA has verified the applicant's claim that the date the investigational device exemption

(IDE)required under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) for human tests to begin became effective November 20, 1996. 2. *The date the application was initially submitted with respect to the device under section 515 of the act (21 U.S.C. 360e)* : January 12, 2001. FDA has verified the applicant's claim that the premarket approval application

(PMA)for INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (PMA P000058) was initially submitted January 12, 2001. 3. *The date the application was approved* : July 2, 2002. FDA has verified the applicant's claim that PMA P000058 was approved on July 2, 2002. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 463 days of patent term extension for U.S. Patent No. 5,984,967 or 347 days of patent term extension for U.S. Patent No. 5,782,919. Anyone with knowledge that any of the dates as published is incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by May 29, 2007. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by September 24, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: March 12, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7-5635 Filed 3-27-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration

(FDA)Chicago District, in cooperation with the Society of Clinical Research Associates (SoCRA), is announcing a workshop on FDA clinical trial statutory and regulatory requirements. This 2-day workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards, and those who interact with them for the purpose of conducting FDA-regulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA. *Date and Time* : The public workshop is scheduled for May 16, 2007, from 8:30 a.m. to 5 p.m. and May 17, 2007, from 8:30 a.m. to 4:30 p.m. *Location* : The public workshop will be held at the Oak Brook Hills Marriott Resort, 3500 Midwest Rd., Oak Brook, IL 60523, 630-850-5555, FAX: 630-850-5569. *Contact* : Marie Falcone, Food and Drug Administration, U.S. Customhouse, 200 Chestnut St., rm. 900, Philadelphia, PA 19106, 215-717-3703, FAX: 215-597-5798, e-mail: *marie.falcone@fda.hhs.gov.* *Registration* : Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $575 (member), $650 (nonmember), or $525 (Federal Government employee nonmember). (Registration fee for nonmembers includes a 1-year membership.) The registration fee for FDA employees is waived. Make the registration fee payable to SoCRA, 530 West Butler Ave., suite 109, Chalfont, PA, 18914. To register via the Internet go to *www.socra.org* (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the **Federal Register** ). The registrar will also accept payment by major credit cards. For more information on the meeting, or for questions on registration, contact 800-SoCRA92 (800-762-7292), or 215-822-8644, or via e-mail: *socramail@aol.com* . Attendees are responsible for their own accommodations. To make reservations at the Oak Brook Hills Marriott Resort, at the reduced conference rate, contact the Oak Brook Hills Marriott Resort (see *Location* ) before April 24, 2007, citing meeting code SCRSCRA. The registration fee will be used to offset the expenses of hosting the conference, including meals, refreshments, meeting rooms, and materials. Space is limited, therefore interested parties are encouraged to register early. Limited onsite registration may be available. Please arrive early to ensure prompt registration. If you need special accommodations due to a disability, please contact Marie Falcone (see *Contact* ) at least 7 days in advance of the workshop. SUPPLEMENTARY INFORMATION: The workshop on FDA clinical trials statutory and regulatory requirements helps fulfill the Department of Health and Human Services' and FDA's important mission to protect the public health by educating researchers on proper conduct of clinical trials. Topics for discussion include the following:

(1)FDA regulation of the conduct of clinical research;

(2)medical device, drug, biological and food product aspects of clinical research;

(3)investigator initiated research;

(4)pre-investigational new drug application meetings and FDA meeting process;

(5)informed consent requirements;

(6)ethics in subject enrollment;

(7)FDA regulation of institutional review boards;

(8)electronic records requirements;

(9)adverse event reporting;

(10)how FDA conducts bioresearch inspections; and

(11)what happens after the FDA inspection. FDA has made education of the research community a high priority to ensure the quality of clinical data and protect research subjects. The workshop helps to implement the objectives of section 406 of the FDA Modernization Act (21 U.S.C. 393) and the FDA Plan for Statutory Compliance, which includes working more closely with stakeholders and ensuring access to needed scientific and technical expertise. The workshop also furthers the goals of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121) by providing outreach activities by Government agencies directed to small businesses. Dated: March 22, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-5633 Filed 3-27-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service American Indians into Psychology; Notice of Competitive Grant Applications for American Indians Into Psychology Program *Announcement Type:* New. *Funding Opportunity Number:* HHS-IHS-2007-INPSY-0001. *CFDA Number:* 92.970. Key Dates: *Application Deadline:* May 7, 2007. *Application Review:* May 30, 2007. *Application Notification:* June 22, 2007. *Anticipated Award Start Date:* August 1, 2007. I. Funding Opportunity Description The Indian Health Service

(IHS)announces that competitive grant applications are being accepted for the American Indians into Psychology Program. This grant is established under the authority of “25 U.S.C. 1621p(a-d).”, Indian Health Care Improvement Act, Pub. L. 94-437, as amended by Pub. L. 102-573. The purpose of the Indians into Psychology Program is to augment the number of Indian health professionals serving Indians by encouraging Indians to enter the health professions and removing the multiple barriers to their entrance into IHS and private practice among Indians. This program is described at 93.970 in the Catalog of Federal Domestic Assistance. Costs will be determined in accordance with applicable Office of Management and Budget Circulars. The Public Health Service

(PHS)is committed to achieving the health promotion and disease prevention objectives of Health People 2010, a PHS-led activity for setting priority areas. This program announcement is related to the priority area of Educational and Community-based programs. Potential applicants may obtain a copy of Healthy People 2010, summary report in print, Stock No. 017-001-00547-9, or via CD-ROM, Stock No. 107-0017-00549-5, through the Superintendent of Documents, Government Printing Office, P.O. Box 371954, Pittsburgh, PA 15250-7945,

(202)512-1800. You may access this information via the Internet at the following Web site: *http://www.health.gov/healthypeople* The Public Health Service strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Pub. L. 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of the facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. II. Award Information *Type of Awards:* Grant. *Estimated Funds Available:* the total amount identified for Fiscal year 2007 is $246,332. The award is for 12 months in duration and the average award is approximately $246,322. Awards under this announcement are subject to the availability of funds. *Anticipated Number of Awards:* An estimated 1 award will be made under the program. If funding becomes available, additional awards may be made. *Project Period:* 36 months. *Award Amount:* $246,322, per year. III. Eligibility Information 1. Eligible Applicants: Public and nonprofit private colleges and universities are eligible to apply for a grant. However, only one grant will be awarded and funded to a college or university per funding cycle. 2. Cost Sharing/Matching: This announcement does not require matching funds or cost sharing. 3. Other Requirements: Required Affiliations—The grant applicant must submit official documentation indicating a Tribe's cooperation with and support of the program within the schools on its reservation and its willingness to have a Tribal representative serving on the program advisory board. Documentation must be in the form prescribed by the Tribe's governing body, i.e., letter of support or Tribal resolution. Documentation must be submitted from every Tribe involved in the grant program. If application budgets exceed the stated dollar amount that is outlined within this announcement it will not be considered for funding. IV. Applicant and Submission Information 1. Applicant package may be found in Grants.gov ( *www.grants.gov* ) or at *http://www.ihs.gov/NonMedicalPrograms/gogp/gogp_funding.asp* . Information regarding the electronic application process may be directed to Michelle G. Bulls, at

(301)443 6528 or *Michelle-Bulls@ihs.gov* . The entire application package is available at: *http://www.grants.gov/Apply.* Detailed application instructions for this announcement are downloadable on *www.Grants.gov* 2. Content and Form of Application Submission: • Be single spaced. • By typewritten. • Have consecutively numbered pages. • Use black type not smaller than 12 characters per one inch. • Contain a narrative that does not exceed 7 typed pages that includes the other submission requirements below. The 7 page narrative does not include the work plan, standard forms, Tribal resolutions or letters of support (if necessary), table of contents, budget, budget justifications, narratives, and/or other appendix items. *Public Policy Requirements:* All Federal-wide public policies apply to IHS grants with the exception of Lobbying and Discrimination. 3. Submission Dates and Times: Applications must be submitted electronically through Grants.gov by 12 midnight Eastern Standard Time (EST). If technical challenges arise and the applicant is unable to successfully complete the electronic application process, the applicant should contact Michelle G. Bulls, Grants Policy Staff, fifteen days prior to the application deadline and advise of the difficulties that your organization is experiencing. The grantee must obtain prior approval, in writing (e-mails are acceptable) allowing the paper submission. If submission of a paper application is requested and approved, the original and two copies may be sent to the appropriate grants contact that is listed in Section IV above. Applications not submitted through Grants.gov, without an approved waiver, may be returned to the applicant without review or consideration. Late applications will not be accepted for processing, will be returned to the applicant and will not be considered for funding. 4. Intergovernmental Review: Executive Order 12372 requiring intergovernmental review is not applicable to this program. 5. Funding Restrictions: • Pre award costs are allowable pending prior approval from the awarding agency. However, in accordance with 45 CFR part 74 all pre award costs are incurred at the recipient's risk. The awarding office is under no obligation to reimburse such costs if for any reason the applicant does not receive an award or if the award to the recipient is less than anticipated. • The available funds are inclusive of direct and appropriate indirect costs. • Only one grant will be awarded per applicant. • IHS will not acknowledge receipt of applications. *Electronic Submission* —The preferred method for receipt of applications is electronic submission through Grants.gov. However, should any technical challenges arise regarding the submission, please contact Grants.gov Customer Support at 1-800-518-4726 or *support@grants.gov* . The Contact Center hours of operation are Monday-Friday from 7 a.m. to 9 p.m. EST. If you require additional assistance please call

(301)443-6290 and identify the need for assistance regarding your Grants.gov application. Your call will be transferred to the appropriate grants staff member. The applicant must seek assistance at least fifteen days prior to the application deadline. Applicants that do not adhere to the timelines for Central Contractor Registry

(CCR)and/or Grants.gov registration and/or requesting timely assistance with technical issues will not be a candidate for paper applications. To submit an application electronically, please use the Grants.gov Search: *www.grants.gov* . Download a copy of the application package on the Grants.gov Web site, complete it offline and then upload and submit the application via the Grants.gov site. You may not e-mail an electronic copy of a grant application to IHS. Please be reminded of the following: • Under the new IHS application submission requirements, paper applications are not the preferred method. However, if you have technical problems submitting your application on line, please directly contact Grants.gov Customer Support at: *http://www.grants.gov/CustomerSupport* . • Upon contacting Grants.gov obtain a tracking number as proof of contact. The tracking number is helpful if there are technical issues that cannot be resolved and a waiver request from Grants Policy must be obtained. • If it is determined that a formal waiver is necessary, the applicant must submit a request, in writing (e-mails are acceptable), to *Michelle.Bulls@ihs.gov* that includes a justification for the need to deviate from the standard electronic submission process. Upon receipt of approval, a hard copy application package must be downloaded by the applicant from Grants.gov, and sent directly to the Division of Grants Operations (DGO), 801 Thompson Avenue, TMP 360, Rockville, MD 20852 by the due date, May 7, 2007. • Upon entering the Grants.gov site, there is information available that outlines the requirements to the applicant regarding electronic submission of an application through Grants.gov, as well as the hours of operation. Applicants must not wait until the deadline date to begin the application process through Grants.gov as the registration process for CCR could take up to fifteen working days. • To use Grants.gov, you, as the applicant, must have a DUNS Number and register in the CCR. You should allow a minimum of ten days working days to complete CCR registration. See below on how to apply. • You must submit all documents electronically, including all information typically included on the SF-424 and all necessary assurances and certifications. • Please use the optional attachment feature in Grants.gov to attach additional documentation that may be requested by IHS. • If Tribal resolutions or letters of support are required, pleas include them as an attachment in your electronic application. • Your application must comply with any page limitation requirements described in the program announcement. • After you electronically submit your application, you will receive an automatic acknowledgement from Grants.gov that contains a Grants.gov tracking number. The DGO will retrieve your application from Grants.gov. The DGO will not notify applicant from Grants.gov. The DGO will not notify applicants that the application has been received. • You may access the electronic application for this program on *http://www.Grants.gov.* • You may search for the downloadable application package using the CFDA number or the Funding Opportunity Number. Both numbers are identified in the heading of this announcement. • The applicant must provide the Funding Opportunity Number: HHS-IHS-2007-INPSY-0001. Again, e-mail applications will not accepted under this announcement. DUNS Number Applicants are required to have a Dun and Bradstreet

(DUNS)number to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a nine digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access *http://www.dunandbradstreet.com* or call 866-705-5711. Interested parties may wish to obtain their DUNS number by phone to expedite the process. Applications submitted electronically must be also be registered with the Central Contractor Registry (CCR). A DUNS number is required before CCR registration can be completed. Many organizations may already have a DUNS number. Please use the number listed above to investigate whether or not your organization has a DUNS number. Registration with the CCR is free of charge. Applicants may register by calling 1-888-227-2423. Please review and complete the CCR Registration Worksheet located on *http://www.grants.gov/CCRRegister.* More detailed information regarding these registration processes can be found at *http://www.grants.gov.* V. Application Review Information Criteria 1. Introduction and Potential Effectiveness of Project (30 pts.) a. Describe your legal status and organization. b. State specific objectives of the project, and the extent to which they are measurable and quantifiable, significant to the needs of Indian people, logical, complete, and consistent with the purpose of section 217. c. Describe briefly what the project intends to accomplish. Identify the expected results, benefits, and outcomes or projects to be derived from each objective of the project. d. Provide a project specific work plan (milestone chart) which lists each objective, the tasks to be conducted in order to reach the objective, and the time fame needed to accomplish each task. Time frames should be projected in a realistic manner to assure that the scope of work can be completed within each budget period. (A work plan format is provided.) e. In the case of proposed projects for identification of Indians with a potential for education or training in the health professions, include a method for assessing the potential of interested Indians for undertaking necessary education or training in such health professions. f. State clearly the criteria by which the project's progress will be evaluated and by which the success of the project will be determined. g. Explain the methodology that will be used to determine if the needs, goals, and objectives identified and discussed in the application are being met and if the results and benefits identified are being achieved. h. Identify who will perform the evaluation and when. 2. Project Administration (20 pts.) a. Provide an organizational chart and describe the administrative, managerial and organizational arrangements and the facilities and resources to be utilized to conduct the proposed project (include in appendix). b. Provide the name and qualifications of the project director or other individuals responsible for the conduct of the project; the qualifications of the principal staff carrying out the project; and a description of the manner in which the applicant's staff is or will be organized and supervised to carry out the proposed project. Include biographical sketches of key personnel (or job descriptions if the position is vacant) (include in appendix). c. Describe any prior experience in administering similar projects. d. Discuss the commitment of the organization, i.e., although not required, the level of non-Federal support. List the intended financial participation, if any, of the applicant in the proposed project specifying the type of contributions such as cash or services, loans of full or part-time staff, equipment, space, materials or facilities or other contributions. e. Describe the ability or provide outreach and recruitment for health professions to Indian communities including elementary and secondary schools and community colleges located on Indian reservations which will be served by the program. f. Incorporate a program advisory board comprised of representatives from the Tribes and communities which will be served by the program. g. To the maximum extent feasible, employ qualified Indians in the program. 3. Accessibility to Target Population (20 pts.) a. Describe the current and proposed participation of Indians (if any) in your organization. b. Identify the target Indian population to be served by your proposed project and the relationship of your organization to that population. c. Describe the methodology to be used to access the target population. d. Identify affiliation agreements with Tribal community colleges, the IHS, university affiliated programs, and other appropriate entities to enhance the education of Indian students. e. Identify existing university tutoring, counseling and student support services. 4. Relationship of Objectives to Manpower Deficiencies (20 pts.) a. Provide data and supporting documentation to substantiate need for recruitment. b. Indicate the number of potential Indian students to be contacted and recruited as well as potential cost per student recruited. Those project that have the potential to serve a greater number of Indians will be given first consideration. 5. Project Budget (10 pts.) a. Clearly define the budget. Provide a justification and detailed breakdown of the funding by category for the first year of the project. Information on the project director and project staff should include salaries and percentage of time assigned to the grant. List equipment purchases necessary to conduct of the project. b. The available funding level of $246,332 is inclusive of both direct and indirect costs or 8 percent of total direct costs. Because this project is for a training grant, the Department of Health and Human Services' policy limiting reimbursement of indirect cost tot he lesser of the applicant's actual indirect costs or 8 percent of total direct costs (exclusive of tuition and related fees and expenditures for equipment) is applicable. This limitation applies to all institutions of higher education. c. The applicant may include as a direct cost tuition and student support for students who have been selected to receive a scholarship through the American Indians into Psychology Program grant. Scholarship support consists of full tuition/fees and a monthly stipend for 12 months. The current stipend is to be $1250.00 per month and adjusted annually at 2%. d. Projects requiring a second and third year must include a program narrative and categorical budget and justification for each additional year of funding requested (this is not considered part of the 15-page narrative). e. Provide budgetary information for summer preparatory programs for Indian students, who need enrichment in the subjects of math and science in order to pursue training in the health professions. f. Provide budget information on stipends that will be provided to undergraduate and graduate students to pursue a career in clinical psychology. Stipends for individuals will not be funded during the first year of the project only if the grantee has not had an established American Indians into Psychology Program grant because the first year will involve recruiting individuals. Stipends must be included in the budget and narrative for the second and third years of the project. Multi-Year Project Requirements 1. Applications must include a narrative, budget, and budget justification for the second and third years of funding. Appendix to include: a. Resumes and position descriptions. b. Organizational Chart. c. Work Plan. d. Tribal Resolution(s)/letters of support. 2. Review and Selection Process. Applications meeting eligibility requirements that are complete, responsive, and conform to this program announcement will be reviewed by an Objective Review Committee

(ORC)in accordance with IHS objective review procedures The objective review process ensures a nationwide competition for limited funding. The ORC will be comprised of IHS (40% or less) or other Federal individuals and (60% or more) non-Federal individuals with appropriate expertise. The ORC will review each application against established criteria. Based upon the evaluation criteria, the reviewer will assign a numerical score to each application, which will be used in making the final funding decision. Approved applications scoring less than 60 points will not be considered for funding. The results of the review are forwarded to the Director, Office of Public Health Support (OPHS), for final review and approval. The Director, OPHS, will also consider the recommendations from the Division of Health Professions Support and the Division of Grants Operations (DGO). 3. Anticipated Announcement and Award Dates. The IHS anticipates an awards start date of August 1, 2007. VI. Award Administration Information 1. Award Notices The Notice of award

(NoA)will be initiated by the DGO and will be mailed via postal mail on or before June 22, 2007 to each entity that is approved for funding under this announcement. The NoA will be signed by the Grants Management Officer and this is the authorizing document for which funds are dispersed to the approved entities. The NoA will serve as the official notification of the grant award and will reflect the amount of Federal funds awarded, the purpose of the grant, the terms and conditions of the award, the effective date of the award, and the budget/project period. The NoA is the legal binding document. Applicants who are approved but unfunded or disapproved based on their Objective Review score will receive a copy of the Executive Summary which identifies the weaknesses and strengths of the application submitted. 2. Administrative Requirements Grants are administered in accordance with the following documents: • This Program Announcement. • 45 CFR Part 92, A Uniform Administrative Requirements for Grants and Cooperative Agreements to State, Local and Tribal Governments, or 45 CFR Part 74, A Uniform Administrative Requirements for Awards to Institutions of Higher Education, Hospitals, Other Non Profit Organizations, and Commercial Organizations. • Grants Policy Guidance: HHS Grants Policy Statement, October 2006. • Cost Principles: OMB Circular A 87, State, Local, and Indian (title 2 Part 225). • Administrative Requirements: OMB Circular A 122, A Non profit Organizations (title 2 Part 230). • Audit Requirements: OMB Circular A 133, Audits of States, Local Governments, and Non profit Organizations. 3. Indirect Costs: This section applies to all grant recipients that request indirect costs in their application. In accordance with HHS Grants Policy Statement, Part II 27, IHS requires applicants to have a current indirect cost rate agreement in place prior to award. The rate agreement must be prepared in accordance with the applicable cost principles and guidance as provided by the cognizant agency or office. A current rate means the rate covering the applicable activities and the award budget period. If current rate is not on file with the awarding office, the award shall include funds for reimbursement of indirect costs. However, the indirect cost portion will remain restricted until the current rate is provided to DGO. Generally, indirect cost rates for IHS Tribal organization grantees are negotiated with the Division of Cost Allocation

(DCA)at *http://rates.psc.gov/,* and indirect cost rates that are for IHS-funded, Federally-recognized Tribes are negotiated with the Department of Interior. If your organization has questions regarding the indirect cost policy, please contact the DGO at

(301)443-5204. 4. Reporting A. Progress Report. Program progress reports are required semi-annually. these reports will include a brief comparison of actual accomplishments to the goals established for the period, reasons for unmet accomplishments (if applicable), and other pertinent information as required. A final report must be submitted within 90 days of expiration of the budget/project period. B. Financial Status Report. Semi-annual financial status reports must be submitted within 30 days of the end of the half year. Final financial status reports are due within 90 days of expiration of the budget/project period. Standard Form 269 (long form) will be used for financial reporting. C. Reports. Grantees are responsible and accountable for accurate reporting of the Progress Reports and Financial Status Reports which are due semi annually. Financial Status Reports (SF 269) are due 90 days after each budget period and the final SF 269 must be verified from the grantee records on how the value was derived. Grantees must submit reports in a reasonable period of time. Failure to submit required reports within the time allowed may result in suspension or termination of an active grant, withholding of additional awards for the project, or other enforcement actions such as withholding of payments or converting to the reimbursement method of payment. Continued failure to submit required reports may result in one or both of the following:

(1)The imposition of special award provisions; and

(2)the non funding or non award of other eligible projects or activities. This applies whether the delinquency is attributable to the failure of the grantee organization or the individual responsible for preparation of the reports. 5. Telecommunication for the hearing impaired is available at: TTY 301-443-6394. VII. Agency Contacts For program information, contact Mrs. Patricia Lee-McCoy, Office of Public Health support, Division of Health Professions Support, 801 Thompson Avenue, TMP Suite 120, Rockville, Maryland 20852,

(301)443-6197, or Mr. Michael Berryhill, Office of Public Health Support, Division of Health Professions Support, 801 Thompson Avenue, TMP Suite 120, Rockville, Maryland 20852

(301)443-6197. For grant application and business management information, contact Ms. Martha Redhouse, Division of Grants Operations, Indian Health Service, 801 Thompson Avenue, TMP Suite 120, Rockville, Maryland 20852

(301)443-5204. Dated: March 22, 2007. Phyllis Eddy, Deputy Director for Management Operations, Indian Health Service. [FR Doc. 07-1498 Filed 3-27-07; 8:45 am]

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