Notices. Notice

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BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0419] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by February 14, 2008. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number 0910-NEW and title, Voluntary National Retail Food Regulatory Program Standards. Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Voluntary National Retail Food Regulatory Program Standards The Program Standards define nine essential elements of an effective regulatory program for retail food establishments, establish basic quality control criteria for each element, and provide a means of recognition for those state, local, and tribal regulatory programs that meet the Program Standards. The program elements addressed by the Program Standards are as follows:

(1)Regulatory foundation,

(2)trained regulatory staff,

(3)inspection program based on Hazard Analysis and Critical Control Point (HACCP) principles,

(4)uniform inspection program,

(5)foodborne illness and food defense preparedness and response,

(6)compliance and enforcement,

(7)industry and community relations,

(8)program support and resources, and

(9)program assessment. Each standard includes a list of records needed to document compliance with the standard (referred to in the Program Standards document as “quality records”) and has one or more corresponding appendices that contain forms and worksheets to facilitate the collection of information needed to assess the retail food regulatory program against that standard. The respondents are state, local and tribal government agencies. Regulatory agencies may use existing, available records or may choose to develop and use alternate forms and worksheets that capture the same information. In the course of their normal activities, state, local, and tribal regulatory agencies already collect and keep on file many of the records needed as quality records to document compliance with each of the Program Standards. Although the detail and format in which this information is collected and recorded may vary by jurisdiction, records that are kept as a usual and customary part of normal agency activities include inspection records, written quality assurance procedures and records of quality assurance checks, staff training certificates and other training records, a log or database of food-related illness or injury complaints, records of investigations resulting from such complaints, an inventory of inspection equipment, records of outside audits, and records of outreach efforts (e.g., meeting agendas and minutes, documentation of food safety education activities). No new recordkeeping burden is associated with these existing records, which are already a part of usual and customary program recordkeeping activities by state, local, and tribal regulatory agencies, and which can serve as quality records under the Program Standards. State, local, and tribal regulatory agencies that enroll in the Program Standards and seek listing in the FDA National Registry are required to report to FDA on the completion of the following three management tasks outlined in the Program Standards:

(1)Conducting a program self assessment;

(2)conducting a baseline survey of the regulated industry; and

(3)obtaining an independent outside audit (verification audit). All three tasks must initially be completed within a 3-year time span. The results are reported to FDA on Form FDA 3519, “FDA National Registry Report” and Form FDA 3520, “Permission to Publish in National Registry.” These forms are located in Appendix I of the Program Standards document. If a regulatory agency follows all the recordkeeping recommendations in the individual standards and their appendices, it will have all the information needed to complete the forms. The time required to complete the forms is minimal. In the **Federal Register** of November 14, 2006 (71 FR 66337), FDA published a 60-day notice requesting public comment on the information collection provisions. FDA received two letters in response to the notice, but the letters contained comments that were not responsive to the four PRA comment requests. These comments will not be addressed in this document. In April 2006, the Conference for Food Protection approved changes to the Program Standards that have been incorporated into a draft 2007 revision, which is available at *http://www.cfsan.fda.gov/~dms/ret4toc.html.* FDA analyzed whether incorporation of the changes alters its estimate of the recordkeeping and reporting burdens as set forth in the 60-day notice. FDA concluded that the changes cause a minor increase and decrease in the recordkeeping burden, resulting in no net change in the recordkeeping burden estimate. FDA further concluded that the reporting burden estimate should be increased by adding a line to table 2 to reflect the addition of 150 hours. This is because the revision to Standard 2 establishes an Assessment of Training Needs

(ATN)process and forms that can be used by regulatory retail food program managers/training officers to prepare Food Safety Inspection officers (FSIOs) to conduct retail food and foodservice inspections (new Appendix B-2 and its accompanying Attachments A and B). As part of the jurisdiction's usual and customary 25 joint field inspections, the jurisdiction's trainer will conduct at least 1 Assessment of Training Needs

(ATN)per new hire. The ATN is a systematic evaluation of the new hire's knowledge, skills, and abilities that are needed before being able to conduct independent inspections. Following the ATN, the jurisdiction's trainer is made aware of any training deficiencies that need to be corrected prior to allowing the new hire to conduct independent work. Regulatory jurisdictions have the flexibility in the ATN to customize training so that it reflects a jurisdiction's administrative policies, sampling procedures, and inspection protocol. The ATN provides two forms to assist food program managers/trainers e forms provide both the candidate and the trainer feedback on specific elements of effective institutional foodservice, restaurant, and retail food store inspections. The forms are

(1)Retail Food, Restaurant, and Institutional Foodservice — Food Safety Inspection Officer, Field Training Worksheet [this form provides a representative baseline of competencies (criteria) expected to be performed by regulatory retail food program FSIOs]. It is to be used during joint field training inspections and is completed as a part of the usual duties of the jurisdiction]; and

(2)Retail Food, Restaurant, and Institutional Foodservice — Food Safety Inspection Officer, Documentation of Successful Completion [this form provides verification that the FSIO has successfully demonstrated the ability to perform all the required competencies (criteria) needed to conduct independent retail food and foodservice inspections. It is completed once at the end of the joint field training process.] FDA estimates that an additional 150 reporting burden hours will result from this change, as discussed later this document. In addition, FDA has increased the recordkeeping burden hour estimate from 157 to 157.1 based on the changes to the 2007 document in the areas of Self Assessment and Verification Audit. Recordkeeping FDA's recordkeeping burden estimate includes time required for a State, local, or tribal agency to review the instructions in the Program Standards, compile information from existing sources, and create any records recommended in the Program Standards that are not already kept in the normal course of the agency's usual and customary activities. Worksheets (Appendices) are provided to assist in this compilation. In estimating the time needed for the program self-assessment (Program Standards 1-8, shown in chart 1 of this document), FDA considered responses from four state and three local jurisdictions that participated in an FDA Program Standards Pilot study. Chart 2 of this document shows the estimated recordkeeping burden for the completion of the baseline data collection and chart 3 of this document shows the estimated recordkeeping burden for the verification audit. The overall program improvement cycle is a 3-year period for completion of all three management tasks. **CHART 1. YEAR ONE — SELF ASSESSMENT** Standard Recordkeeping Activity Hours per Recordkeeper (Year One) No.1 Regulatory Foundation Self Assessment: (Appendix A) Completion of worksheet recording results of evaluations and comparison on worksheets. 1 16 No. 2 Trained Regulatory Staff Self Assessment: (Appendix B-2 and B-4) 1 Completion of ATN Field Training Worksheet and Documentation of Successful Completion — Field Training Process; completion of summary worksheet of each employee training records. 2 19.3 No. 3 HACCP Principles Self Assessment: (Appendix C 1 ) Completion of worksheet documentation. 4 No. 4 Uniform Inspection Program Self Assessment: (Appendix D 1 ) Completion of worksheet documentation of jurisdiction's quality assurance procedures 2 19 No. 5 Foodborne Illness Investigation Self Assessment: (Appendix E 1 ) Completion of worksheet documentation. 5 No. 6 Compliance Enforcement Self Assessment: (Appendix F 1 ) Selection and review of 20 to 70 establishment files @ 25 minutes per file. Estimate is based on a mean number of 45. Completion of worksheet. 19 No. 7 Industry & Community Relations Self Assessment: (Appendix G 1 ) Completion of worksheet. 2 No. 8 Program Support and Resources Self Assessment: (Appendix H 1 ) Selection and review of establishment files 8 SUBTOTAL 92.3 Hours 1 Or comparable documentation 2 Estimates will vary depending on number of regulated food establishments and the number of inspectors employed by the jurisdiction. **CHART 2. YEAR TWO — BASELINE DATA COLLECTION** Standard Recordkeeping Activity Hours per Recordkeeper (Year Two) No. 9 Program Assessment Baseline Data Collection (Appendices I & J) Selection and inspection of randomly selected statistical sample of 9 to 87 establishments from each of 9 facility types. 1 333 1 Calculation based on mean sample size of 39 and average FDA inspection time for each establishment type. Estimates will vary depending on number of regulated food establishments within a jurisdiction and the number of inspectors employed by the jurisdiction. **CHART 3. YEAR THREE — VERIFICATION AUDIT** Standard Recordkeeping Activity Hours per Recordkeeper (Year Three) No. 9 Verification Audit (Appendices I & J) 1 46.15 1 We estimate that no more than 50% of time spent to complete self assessment of all 9 standards is spent completing verification audit worksheets. Time will be considerably less if less than 9 standards require verification audits. FDA estimated the annual hours per recordkeeper (i.e., per enrolled jurisdiction) in table 1 of this document by adding the recordkeeping estimates for the management tasks of self assessment, baseline data collection, and verification audit (charts 1, 2, and 3 of this document) that enrolled jurisdictions must perform during a 3-year cycle (92.3 + 333 + 46.15 = 471.45, then dividing the total by three to obtain an annual average (471.45 / 3 = 157.1). The estimates in tables 1 and 2 of this document are based on the estimated participation of 500 regulatory jurisdictions in the Program Standards. Table 1 shows an increase of 50 hours in the overall recordkeeping burden estimate based on a 0.1 increase in the estimate of annual hours per recordkeeper in the 2007 document. There are approximately 3,000 jurisdictions in the United States and its territories that have retail food regulatory programs. Enrollment in the Program Standards is voluntary, and therefore FDA does not expect all jurisdictions to participate in the near future. In its 2002 operational plan, the FDA National Retail Food Team established a goal of enrolling 15 percent of eligible agencies, or 450 programs, in the Program Standards by the year 2010. For purposes of this burden estimate, it is reasonable to take into account the possibility that this goal could be exceeded by approximately 10 percent, for a total of approximately 500 participating agencies. Thus, FDA estimates the recordkeeping burden for this collection of information as follows: **Table 1.—Estimated Annual Recordkeeping Burden** 1 FDA Worksheets 2 No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours Appendices A-J 500 1 500 157 78,550 Total Burden Hours 78,550 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Or comparable documentation. Reporting Based on the number and nature of the items that need to be completed, FDA estimates a total of 12 minutes annually for each enrolled jurisdiction to complete both FDA Form 3519, “FDA National Registry Report,” and Form 3520, “Permission to Publish in National Registry.” Form 3519 requires the name and address of the jurisdiction; completion dates for the self assessment, baseline survey (original and update), and verification audit; names of the person(s) who completed the self-assessment, verification audit, baseline survey, baseline survey update, and action plan; signature of the program manager; and date the form was completed. Form 3520 requires the name of the jurisdiction, completion date of the self assessment, date of the verification audit report, name of the auditor, signature and title of the official completing the form, and date the form was completed. FDA has added a line and 150 hours to table 2, due to the changes to the Program Standards approved by the 2006 Conference for Food Protection. Based on the two forms required for the ATN, the nature of the items that need to be completed, and the number of new hires, FDA estimates a total of 150 hours annually for completion of the completion ATN Field Training Worksheet and Documentation of Successful Completion — Field Training Process; (500 jurisdictions with 3 new hires per year at 6 minutes for completion of all forms equals 150 hours per year for completion of both Summary forms). As explained previously in this document, FDA estimates that 500 regulatory jurisdictions will enroll in the Program Standards. The reporting burden in table 2 of this document includes only the time necessary to fill out and send the forms, as compiling the underlying information (including self-assessment reports, baseline surveys, outside audits, and supporting documentation) is accounted for under the recordkeeping estimates in table 1 of this document. Thus, FDA estimates the reporting burden for this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 FDA Forms No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 3519 500 1 500 6 min 50 hours 3520 500 1 500 6min 50 hours Retail Food, Restaurant, and Institutional Foodservice — FSIO, Documentation of Successful Completion 500 3 1,500 6 min 150 hours Total Burden Hours 78,550 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: December 27, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-542 Filed 1-14-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0495] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, FDA Form 3602A 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 FDA Form 3602A, which will allow a foreign business to qualify as a “small business” and pay certain medical device user fees at reduced rates. DATES: Submit written or electronic comments on the collection of information by March 17, 2008. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . 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: Denver Presley Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472 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. Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, Form FDA 3602A—(21 U.S.C.379j) (OMB Control Number 0910-0613—Extension) The FDA Amendments Act of 2007 includes the “Medical Device User Fee Amendments of 2007” (the 2007 Amendments), which reauthorizes medical device user fees for fiscal years

(FY)2008 through 2012 and which makes significant changes to the medical device user fee provisions of the act. The 2007 Amendments provide a new way for a foreign business to qualify as a small business eligible to pay a significantly-lower fee when a medical device user fee must be paid. Before passage of the 2007 Amendments, the only way a business could qualify as a small business was to submit a Federal (U.S.) income tax return showing its gross receipts or sales that did not exceed a statutory threshold, currently, $100 million. If a business could not provide a Federal income tax return, it did not qualify as a small business and had to pay the standard

(full)fee. Because many foreign businesses have not, and cannot, file a Federal (U.S.) income tax return, this requirement has effectively prevented those businesses from qualifying for the small business fee rates. Thus, foreign governments, including the European Union, have objected. In lieu of a Federal income tax return, the 2007 Amendments will allow a foreign business to qualify as a small business by submitting a certification from its national taxing authority, the foreign equivalent of our Internal Revenue Service. This certification, referred to as a “National Taxing Authority Certification,” must: • Be in English; • Be from the national taxing authority of the country in which the business is headquartered; • Provide the business' gross receipts or sales for the most recent year, in both the local currency and in U.S. dollars, and the exchange rate used in converting local currency to U.S. dollars; • Provide the dates during which the reported receipts or sales were collected; and • Bear the official seal of the national taxing authority. The new FDA Form 3602A, “FY 2008 MDUFMA Foreign Small Business Qualification Certification,” will collect the information required by the statute and allows a foreign business to qualify for the same small business benefits as a domestic U.S. business. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 FDA Form 3602A No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Sections I and II (completed by the business seeking small business status) 229 1 229 1 229 Section III (completed by the foreign national taxing authority) 33 7 231 1 231 Total 460 1 There are no capital costs or operating and maintenance costs associated with this collection of information. This burden estimate is based on an examination of 510(k) premarket notifications received during FY 2006 and FDA's estimation of the time to collect the required information to complete FDA Form 3602A. The evidence supporting each FDA Form 3602A must be reviewed by a foreign national taxing authority to complete Section III, the National Taxing Authority Certification, of each FDA Form 3602A. Because this is a new activity, and neither FDA nor any foreign national taxing authority has any data that would provide an objective measure of the effort required to complete Section III, FDA is estimating that the burden will be the same as FDA experiences in reviewing FDA Form 3602, “FY 2008 MDUFMA Small Business Qualification Certification For a Business Headquartered in the United States,” approved under OMB control number 0910-0508. FDA believes most entities that submit FDA Form 3602A will not have any affiliates, and very few will have more than three or four affiliates. Based on our experience with FDA Form 3602, FDA believes each business will require 1 hour to complete Sections I and II. Because this is a new requirement, FDA does not have any data on the time that will be required to complete Section III, the National Taxing Authority Certification. Please note that in January 2008, the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. After the transition date, electronic submissions will be accepted by FDA through the FDMS only. When the exact date of the transition to FDMS is known, FDA will publish a **Federal Register** notice announcing that date. Dated: January 9, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-569 Filed 1-14-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2008N-0007] Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(EMEA)of the Common EMEA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671). DATES: Submit written or electronic comments on the collection of information by March 17, 2008. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . 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 collection of information, FDA invites comments on these topics:

(1)the clarity and ease of use of this proposed common application form;

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

(3)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(4)ways to enhance the quality, utility, and clarity of the information to be collected; and

(5)ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques, when appropriate, and other forms of information technology. Orphan Drugs; Common EMEA/FDA Application Form for Orphan Medicinal Product Designation (Form FDA 3671) (OMB Control Number 0910-0167)—Extension Sections 525 and 526 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aa and 360dd) give FDA statutory authority to do the following:

(1)Provide recommendations on investigations required for approval of marketing applications for orphan drugs,

(2)designate eligible drugs as orphan drugs,

(3)set forth conditions under which a sponsor of an approved orphan drug obtains exclusive approval, and

(4)encourage sponsors to make orphan drugs available for treatment on an “open protocol” basis before the drug has been approved for general marketing. The implementing regulations for these statutory requirements have been codified under part 316 (21 CFR part 316) and specify procedures that sponsors of orphan drugs use in availing themselves of the incentives provided for orphan drugs in the act and sets forth procedures FDA will use in administering the act with regard to orphan drugs. Section 316.10 specifies the content and format of a request for written recommendations concerning the non-clinical laboratory studies and clinical investigations necessary for approval of marketing applications. Section 316.12 provides that, before providing such recommendations, FDA may require results of studies to be submitted for review. Section 316.14 contains provisions permitting FDA to refuse to provide written recommendations under certain circumstances. Within 90 days of any refusal, a sponsor may submit additional information specified by FDA. Section 316.20 specifies the content and format of an orphan drug application which includes requirements that an applicant document that the disease is rare (affects fewer than 200,000 persons in the United States annually) or that the sponsor of the drug has no reasonable expectation of recovering costs of research and development of the drug. Section 316.26 allows an applicant to amend the applications under certain circumstances. Section 316.30 requires submission of annual reports, including progress reports on studies, a description of the investigational plan, and a discussion of changes that may affect orphan status. The information requested will provide the basis for an FDA determination that the drug is for a rare disease or condition and satisfies the requirements for obtaining orphan drug status. Secondly, the information will describe the medical and regulatory history of the drug. The respondents to this collection of information are biotechnology firms, drug companies, and academic clinical researchers. The information requested from respondents represents, for the most part, an accounting of information already in the possession of the applicant. It is estimated, based on frequency of requests over the past 5 years, that 171 persons or organizations per year will request orphan-drug designation and none will request formal recommendations on design of preclinical or clinical studies. The Common EMEA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671) is intended to benefit sponsors who desire to seek orphan designation of drugs intended for rare diseases or conditions from both the European Commission and FDA by reducing the burden of preparing separate applications to meet the regulatory requirements in each jurisdiction. It highlights the regulatory cooperation between the United States

(US)and the European Union

(EU)mandated by the Transatlantic Economic Council (TEC). The TEC mandate involves the following:

(1)Removal of barriers to transatlantic commerce;

(2)rationalizing, reforming, and, where appropriate, reducing regulations to empower the private sector;

(3)achieving more effective, systematic, and transparent regulatory cooperation to reduce costs associated with regulation to consumers and producers;

(4)removing unnecessary differences between jurisdictional regulations to foster economic integration; and

(5)reinforcing the existing transatlantic dialogue structures in regulatory cooperation, both by intensifying our sector-by-sector US-EU regulatory cooperation and our dialogue between OMB and the European Commission services on methodological issues. At present, when seeking orphan designation of the same drug for the diagnosis, treatment, or prevention of the same rare disease or condition in the US and in the European Community, a sponsor must submit a designation request to FDA (in accordance with section 526 of the act) and a separate designation application to EMEA (in accordance with Regulation

(EC)No. 141/2000 of December 16, 1999, and Commission Regulation

(EC)No. 847/2000). In most cases, the two documents are formatted differently to meet regulatory demands, but the required core information elements are similar, with the exception of some unique regulatory requirements exclusive to each jurisdiction. Therefore, FDA and EMEA believe that a common application form will help reduce the sponsor's regulatory burden and costs to produce and submit differently-formatted request/application. In addition, a common application form may also streamline the administrative and substantive regulatory review processes, and aid in information exchange between the agencies. In accordance with the Confidentiality Arrangements concluded on September 12, 2003, between the European Commission, EMEA, and FDA/Department of Health and Human Services (DHHS), 1 FDA and EMEA have agreed in principle to adopt a template for the common application form as proposed in form FDA 3671. 1 See “Confidentiality Arrangements Concluded Between the EU (EC and EMEA) and the US FDA/DHHS Implementation Plan for Medicinal Products for Human Use” at *http://www.fda.gov/oia/arrangements0904.html* . Any sponsor seeking orphan designation of the same drug for the same disease or condition from both FDA and EMEA may use this common application form for regulatory filing purposes. A sponsor may also use this common application form when seeking designation only from FDA. This common application form is intended to complement, not to supersede, the relevant regulatory frameworks currently in effect. The sponsor must comply with all applicable regulatory requirements in each jurisdiction in which it seeks designation when using this common application form. To use the common application form, the sponsor must provide the required information in each applicable section as instructed in the explanatory notes. Certain information elements are identified in the form as required exclusively by either FDA or EMEA regulations, and as such they must be included only in the application to that jurisdiction. Where additional explanations and/or supportive documents are necessary, the sponsor should sequentially append them at the end of the common application form in the order they appear in the form. The sponsor must also complete the declaration and signature page. For FDA, the completed common application form and required appended documents must be submitted to the Office of Orphan Products Development (HF-35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. For EMEA, the completed documents must be submitted to European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom. FDA estimates the reporting burden of this common application form as follows. Between January 2000 and May 2006, FDA and EMEA received 226 comparable orphan designation requests/applications of the same drugs for the same diseases or conditions, or an average of 35 per year. With the ease of a common application form, FDA anticipates the number of such requests/applications may increase over time. Therefore, generally there is one request/application per respondent and, at the extreme, all respondent are US-based, FDA believes up to 40 such respondents may use the common application form each year. The respondents will be primarily pharmaceutical companies or other for-profit organizations. For applications submitted exclusively to FDA, we do not believe the new form will result in any increased burden on the respondents and therefore we estimate no additional burden for those respondents. FDA believes the information required for the EMEA submission, for the most part, is very similar to that in the FDA submission, which is already in the respondents' possession. The respondents, however, may have to search existing data sources or gather additional needed data, such as on the prevalence or the availability of alternative methods of diagnosis, prevention, and treatment of the rare disease or condition of interest in the European Community, to complete the EMEA submission. FDA estimates that it will take an additional 32 hours—16 hours of professional time and 16 hours of support time—to compile information required for the EMEA submission. Hence, the estimated total annual human resource hours, at most, would be 1,280 hours for the EMEA submission. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section and FDA Form Annual No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 316.10, 316.12, 316.14 5 1 5 130 650 316.20, 316.21, 316.26 171 2.0 342 130 44,460 316.20, 316.21, 316.26 40 1 40 32 1,280 Form FDA 3671 316.22 30 1 30 2 60 316.30 500 1 500 2 1,000 316.36 .2 3 .6 15 9 Total 47,559 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Please note that in January 2008, the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. After the transition date, electronic submissions will be accepted by FDA through the FDMS only. When the exact date of the transition to FDMS is known, FDA will publish a **Federal Register** notice announcing that date. Dated: January 7, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-571 Filed 1-14-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0240] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4816. SUPPLEMENTARY INFORMATION: In the **Federal Register** of October 11, 2007 (72 FR 57950), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0233. The approval expires on January 31, 2011. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: January 9, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-573 Filed 1-14-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committees; Tentative Schedule of Meetings for 2008 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2008. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of the IOM's recommendations was for the agency to publish an annual tentative schedule of its meetings in the **Federal Register** . This publication implements the IOM's recommendation. FOR FURTHER INFORMATION CONTACT: Theresa L. Green, Advisory Committee Oversight and Management Staff (HF-4), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1220. SUPPLEMENTARY INFORMATION: The IOM, at the request of the Commissioner, undertook a study of the use of FDA's advisory committees. In its final report in 1992, one of the IOM's recommendations was for FDA to adopt a policy of publishing an advance yearly schedule of its upcoming public advisory committee meetings in the **Federal Register** ; FDA has implemented this recommendation. The annual publication of tentatively scheduled advisory committee meetings will provide both advisory committee members and the public with the opportunity, in advance, to schedule attendance at FDA's upcoming advisory committee meetings. Because the schedule is tentative, amendments to this notice will not be published in the **Federal Register** . However, changes to the schedule will be posted on the FDA advisory committees' Internet site located at *http://www.fda.gov/oc/advisory/default.htm* . FDA will continue to publish a **Federal Register** notice 15 days in advance of each upcoming advisory committee meeting, to announce the meeting (21 CFR 14.20). The following list announces FDA's tentatively scheduled advisory committee meetings for 2008. You may also obtain up-to-date information by calling the Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). Committee Name Tentative Date of Meeting(s) Advisory Committee 10-Digit Information Line Code OFFICE OF THE COMMISSIONER Pediatric Advisory Committee March and November days to be announced 8732310001 Risk Communication Advisory Committee February 28-29, May 15-16, August 21-22, November 17-18 8732112560 Science Board to FDA May and October days to be announced 3014512603 CENTER FOR BIOLOGICS EVALUATION AND RESEARCH Allergenic Products Advisory Committee April 29, October 17 3014512388 Blood Products Advisory Committee May 1-2, August 14-15, December 11-12 3014519516 Cellular, Tissue and Gene Therapies Advisory Committee April 10-11, November 13-14 3014512389 Transmissible Spongiform Encephalopathies Advisory Committee To be announced 3014512392 Vaccines and Related Biological Products Advisory Committee February 20-21, May 21-22, September 24-25, November 19-20 3014512391 CENTER FOR DRUG EVALUATION AND RESEARCH Anesthetic and Life Support Drugs Advisory Committee March 11, May days to be announced 3014512529 Anti-Infective Drugs Advisory Committee February 27-28, April 1-3 3014512530 Antiviral Drugs Advisory Committee To be announced 3014512531 Arthritis Advisory Committee July, September, and November days to be announced 3014512532 Cardiovascular and Renal Drugs Advisory Committee June 24-25, August 19-20, December 9-10 3014512533 Dermatologic and Ophthalmic Drugs Advisory Committee April days to be announced 3014512534 Drug Safety and Risk Management Advisory Committee February 1, May days to be announced 3014512535 Endocrinologic and Metabolic Drugs Advisory Committee April 16-17, July 1-2, October 29-30, November 19-20 3014512536 Gastrointestinal Drugs Advisory Committee January 23, May days to be announced 3014512538 Nonprescription Drugs Advisory Committee To be announced 3014512541 Oncologic Drugs Advisory Committee March 13, April days to be announced, May 30, September 10-11, December 15-16 3014512542 Peripheral and Central Nervous System Drugs Advisory Committee May days to be announced 3014512543 Pharmaceutical Science and Clinical Pharmacology, Advisory Committee for March 18-19 3014512539 Psychopharmacologic Drugs Advisory Committee February 6 3014512544 Pulmonary-Allergy Drugs Advisory Committee February 20 3014512545 Reproductive Health Drugs, Advisory Committee for To be announced 3014512537 CENTER FOR DEVICES AND RADIOLOGICAL HEALTH Device Good Manufacturing Practice Advisory Committee August 12, October 20-21 3014512398 Medical Devices Advisory Committee (Comprised of 18 Panels) Anesthesiology and Respiratory Therapy Devices Panel January 23, March 26, September 17 3014512624 Circulatory System Devices Panel August 26-27, November 14-15 3014512625 Clinical Chemistry and Clinical Toxicology Devices Panel April 9-10, August 13-14, December 4-5 3014512514 Dental Products Panel June 11, September 10, November 19 3014512518 Ear, Nose, and Throat Devices Panel April 16-17, June 25-26, August 28-29, October 28-29, December 10-11 3014512522 Gastroenterology-Urology Devices Panel October 17 3014512523 General and Plastic Surgery Devices Panel June 10-11, October 21-22 3014512519 General Hospital and Personal Use Devices Panel May 6-7, September 16-17 3014512520 Hematology and Pathology Devices Panel April 25, October 17 3014512515 Immunology Devices Panel November 6-7 3014512516 Medical Devices Dispute Resolution Panel To be announced as needed 3014510232 Microbiology Devices Panel April 24-25, June 19-20, October 23-24 3014512517 Molecular and Clinical Genetics Panel May 6-7, November 11-12 3014510231 Neurological Devices Panel March 25-26, June 3-4, September 23-24, November 6-7 3014512513 Obstetrics and Gynecology Devices Panel April 17-18, June 19-20, August 14-15, October 16-17, December 11-12 3014512524 Ophthalmic Devices Panel February 21-22, May 15-16, September 18-19, November 20-21 3014512396 Orthopedic and Rehabilitation Devices Panel April 21-22, June 16-17, August 18-19, October 20-21, December 8-9 3014512521 Radiological Devices Panel April 15-16, August 12, November 4 3014512526 National Mammography Quality Assurance Advisory Committee October 13-14 3014512397 Technical Electronic Product Radiation Safety Standards Committee October 8 3014512399 CENTER FOR FOOD SAFETY AND APPLIED NUTRITION Food Advisory Committee July 22, December 2 3014510564 CENTER FOR VETERINARY MEDICINE Veterinary Medicine Advisory Committee March day to be announced 3014512548 National Center for Toxicological Research

(NCTR)Science Advisory Board to NCTR August 12-13 3014512559 Dated: January 7, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8-567 Filed 1-14-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration

(FDA)is announcing an amendment to the notice of meeting of the Drug Safety and Risk Management Advisory Committee. This meeting was announced in the **Federal Register** of December 11, 2007 (72 FR 70336). The amendment is being made to reflect a change in the *Agenda* portion of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Teresa A. Watkins, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: *Teresa.Watkins@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington DC area), code 3014512535. Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the **Federal Register** of December 11, 2007, FDA announced that a meeting of the Drug Safety and Risk Management Advisory Committee would be held on February 1, 2008. On page 70336, in the second column, the first paragraph of the *Agenda* portion of document is amended to read as follows: *Agenda* : The committee will discuss the efficacy and safety of new drug application

(NDA)22-054, INJECTAFER (ferric carboxymaltose injection), Luitpold Pharmaceuticals Inc., used for the treatment of iron deficiency anemia in postpartum patients or iron deficiency anemia in patients with heavy uterine bleeding. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: January 7, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8-490 Filed 1-14-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notification of Exception to Competition AGENCY: Health Resources and Services Administration, HHS. ACTION: Notification of Exception to Competition. SUMMARY: The Health Resources and Services Administration

(HRSA)is issuing a non-competitive program expansion supplement to the National Health Care for the Homeless Council (NHCHC) to provide expanded training and technical assistance to HRSA-funded grantees serving individuals who are homeless. *Authority:* This activity is under the authority of the Public Health Service Act, section 330(l). Catalog of Federal Domestic Assistance Number: 93.224. *Background:* The National Health Care for the Homeless Council (NHCHC) is a cooperative agreement grantee that provides training and technical assistance support to health centers that serve homeless individuals and families. The NHCHC requires supplemental funding to provide, through expanded regional and national training activities, a broader and enriched menu of support for HRSA grantees, including Health Care for the Homeless

(HCH)administrators, clinicians, and members of HCH Boards of Directors and consumer advisory groups. *Amount:* The amount of the award is $225,000. *Project Period:* July 1, 2006, to June 30, 2008. *Budget Period Supplemented:* July 1, 2007, to June 30, 2008. *Justification for The Exception to Competition:* Given the recent growth of the HCH component of HRSA's Health Center program, it is critical that expanded regional and national training be provided in as timely a manner as possible. This supplemental request is being awarded noncompetitively because, at this time, there are no other organizations with the expertise to complete these activities, and no other organization is prepared to provide these services within the timeframe in which they are needed. Due to the emerging and urgent needs of the HCH program, this supplemental request and the activities proposed are essential to ensuring successful delivery of health care to the target population. FOR FURTHER INFORMATION CONTACT: Jean L. Hochron, M.P.H., Director, Office of Minority and Special Populations, Bureau of Primary Health Care, Health Resources and Services Administration, 5600 Fishers Lane, Room 16-105, Rockville, MD 20857; *phone:* 301-594-4437, FAX 301-443-0248, e-mail *jhochron@hrsa.gov* . Dated: January 8, 2008. Elizabeth M. Duke, Administrator. [FR Doc. E8-582 Filed 1-14-08; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on Migrant Health; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: *Name:* National Advisory Council on Migrant Health. *Dates and Times:* February 5, 2008, 8:30 a.m. to 5 p.m., February 6, 2008, 8:30 a.m. to 5 p.m. *Place:* 5600 Fishers Lane, Room 17-05, Rockville, Maryland 20857, *Telephone:*

(301)594-0367, *Fax:*

(301)443-0248. *Status:* The meeting will be open to the public. *Purpose:* The purpose of the meeting is to discuss services and issues related to the health of migrant and seasonal farmworkers and their families and to formulate recommendations for the Secretary of Health and Human Services. *Agenda:* The agenda includes an overview of the Council's general business activities. The Council will also hear presentations from experts on farmworker issues, including the status of farmworker health at the local and national levels. Agenda items are subject to change as priorities indicate. *For Further Information Contact:* Gladys Cate, Office of Minority and Special Populations, Bureau of Primary Health Care, Health Resources and Services Administration, 5600 Fishers Lane, Maryland 20857; telephone

(301)594-0367. Dated: January 8, 2008. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E8-526 Filed 1-14-08; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on the National Health Service Corps; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: *Name:* National Advisory Council on the National Health Service Corps. *Dates and Times:* February 28, 2008, 3 p.m.-5 p.m.; February 29, 2008, 8:30 a.m.-5 p.m.; and March 1, 2008, 9 a.m.-5 p.m. *Place:* Hilton Washington DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, Maryland, United States 20852-1699, *Tel:* 1-301-468-1100 Fax: 1-301-468-0308. *Status:* The meeting will be open to the public. *Agenda:* The program staff will be presenting information relative to the reorganization of the Bureau of Clinician Recruitment and Service and how the new structure will impact the implementation of the National Health Service Corps Program. *For Further Information Contact:* Tira Patterson, Bureau of Clinician Recruitment and Service, Health Resources and Services Administration, Parklawn Building, Room 8A-55, 5600 Fishers Lane, Rockville, MD 20857; *e-mail: TPatterson@hrsa.gov; telephone:*

(301)594-4140. Dated: January 9, 2008. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E8-581 Filed 1-14-08; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Small Rural Hospital Improvement Grant Program AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice for public comment. SUMMARY: The Health Resources and Services Administration

(HRSA)is seeking comments from the public on its plan to institute a permanent deviation from a policy in the Department of Health and Human Services (HHS), Grants Policy Directive

(GPD)3.01 governing indirect cost recovery for one of its grant programs. The GPD states “HHS considers activities conducted by grantees that result in indirect charges a necessary and appropriate part of HHS grants, and HHS awarding offices must reimburse their share of these costs.” Although HRSA typically reimburses grantees for their full share of administrative overhead represented in approved indirect cost rates (which can be up to 50 percent or higher), the Agency believes, in the case of its Small Rural Hospital Improvement Grant Program (SHIP), that full recovery of overhead expenditures would be detrimental to the ability to adequately conduct the activities mandated in the authorizing legislation. The purpose of the SHIP grant program is to assist eligible small rural hospitals in implementing Prospective Payments Systems (PPS), compliance with the Health Insurance Portability and Accountability Act (HIPAA) regulations, and to reduce medical errors and to support quality improvement. Funding for the SHIP grant program is routed first through the State Offices of Rural Health (SORH); they are then distributed evenly by the SORH to the individual hospitals. This process creates efficiencies because of the large number of eligible hospitals and relatively small size of each award. In fiscal year 2007, $14,508,691 was awarded to 1,622 hospitals (approximately $8,945 each) in 46 States. Thus, the SORH is the official grantee of record for the State, as the recipient of the award and fiscal intermediary for the Federal government in distributing the funds. It is in the best interest of the SHIP grant program to limit the total administrative cost recovery to 5 percent of the Federal award, thereby allowing 95 percent of available grant funds to be used to carry out the required program activities. Since the SHIP grant program began in FY 02, through FY 07, the administrative costs have been restricted. Indirect costs were not allowed and there was a five percent maximum of other costs, for administrative costs, within the grant guidance. The SORHs voluntarily decided to limit these cost categories. For FY 07, the average administrative charge was only 3.64 percent. Thus, the cap on administrative costs has worked well. Limiting administrative costs is necessary because 20 percent of SHIP grantees are located in academic settings that have established indirect cost rates in the range of 30 to 50 percent. Without a limitation on the amount of grant funds allocated for administrative costs, the SORH grantee could potentially charge its full indirect cost rate and the grant awards would be significantly less for each small rural hospital. As much as 50 percent of the grant award could be consumed by indirect costs, depending upon the host institution's indirect cost rate. This would significantly reduce the amount of funds available to initiate and maintain the activities of the grant. A limitation on administrative costs will ensure that each hospital, not an unintended source, receives the maximum amount of funding. The limitations placed on these cost categories will ensure that the majority of funding is routed to the small rural hospitals, to be used for the prescribed intents and purposes of the grant program. A continued limitation on administrative costs for future SHIP grant cycles will help to assure that small rural hospitals receive the appropriated support, necessary to carry out the objectives of the grant program. The limitation would be applicable to all grantees of the Small Rural Hospital Improvement Grant Program. DATES: If you wish to comment on any portion of this notice, HRSA must receive comments by February 14, 2008. ADDRESSES: You may submit comments by any of the following methods: • *E-mail: JChang@hrsa.gov* . Include “Small Rural Hospital Improvement Grant Program” in the subject line of the message. • *Mail:* Jennifer Chang, Office of Rural Health Policy, Health Resources and Services Administration, 5600 Fishers Lane, Room 9A-42, Rockville, MD 20857. • *Hand Delivery/Courier:* Jennifer Chang, Office of Rural Health Policy, Health Resources and Services Administration, 5600 Fishers Lane, Room 9A-42, Rockville, MD 20857. *Docket:* For access to the docket to read background documents or comments received, go to the Office of Rural Health Policy, Health Resources and Services Administration, 5600 Fishers Lane, Room 9A-42, Rockville, Maryland 20857, weekdays between the hours of 8:30 a.m. and 5 p.m. To schedule an appointment to view public comments, phone

(301)443-0835. FOR FURTHER INFORMATION CONTACT: Jennifer Chang, at the above address, telephone number 301-443-0835. SUPPLEMENTARY INFORMATION: The HRSA SHIP grant program is authorized by Section 1820(g)(3) of the Social Security Act, 42 U.S.C. 1395i-4. The purpose of the SHIP grant program is to help small rural hospitals perform any or all of the following:

(1)Pay for costs related to implementation of PPS,

(2)comply with HIPAA provisions of 1996 and

(3)reduce medical errors and support quality improvement. The SHIP grant program funds are geared towards assisting small rural hospitals that are essential access points for Medicare and Medicaid beneficiaries. Eligible small rural hospitals (49 available beds or less) are non-Federal, short-term general acute care facilities that are located in a rural area of the U.S. and the territories, including faith-based hospitals. Because of the large number of hospitals and relatively small size of each award, the SHIP funds are routed through the SORH, then to individual hospitals. Eligible hospitals must submit a hospital application to their SORH, by the designated deadline, to receive funding. The SORH is the official grantee of record and acts as a fiscal intermediary for all hospitals within their State. In turn, the SORH verifies hospital eligibility and submits a single grant application to the Federal Government on behalf of all eligible hospital applicants in the State. Since the SHIP program began in FY 02, through FY 07, the administrative costs have been restricted. Indirect costs were not allowed and there was a five percent maximum of other costs, for administrative charges, within the grant guidance. The limitations were placed on these cost categories to ensure that the majority of funding would be routed to the hospitals, to be used for the prescribed intents and purposes of the grant program. For FY 07, the SHIP grant program allocated $14,508,691 to a total of 1,622 hospitals in 46 States, which is about $8,945 per hospital. Without a limitation on the amount of grant funds allocated for administrative costs, the grantee could potentially charge its full indirect cost rate, thereby significantly reducing the funds available to small rural hospitals. Approximately 20 percent of the SORHs are housed in universities, which have established indirect cost rates ranging from 30 to 50 percent, or higher. Limiting the administrative cost recovery will continue to help ensure that small rural hospitals are continuously provided the support necessary to carry out the objectives of the grant program. To maintain the limit on all administrative costs in the 2008 grant funding opportunity guidance, a request to deviate from the HHS GPD 3.01, Indirect Costs and Other Cost Policies was required. Such a request was submitted and approved by the HHS, Office of Grants Policy, Oversight and Evaluation, Assistant Secretary for Resources and Technology in November, 2007. Public Comment HRSA invites public comment on its intent to indefinitely limit the total administrative cost recovery to five percent of the Federal award for awardees of the Small Rural Hospital Improvement Grant Program. Dated: January 7, 2008. Elizabeth M. Duke, Administrator. [FR Doc. E8-525 Filed 1-14-08; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration State Offices of Rural Health Grant Program AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice; request for public comment. SUMMARY: The Health Resources and Services Administration

(HRSA)is seeking comments from the public on its plan to institute a permanent deviation from a policy in the Department of Health and Human Services (HHS), Grants Policy Directive

(SORH)Grant Program, that full recovery of overhead expenditures would be detrimental to the SORH grantees' ability to adequately conduct all the activities mandated in the authorizing legislation. Limiting indirect cost recovery is necessary because eleven of fifty SORH grantees are located in academic settings that have established indirect cost rates in the range of 30 to 50 percent or even higher. It is in the best interest of the program to limit the indirect cost recovery to not more than 15 percent of allowable total direct costs, thus leaving 85 percent of the grant funds to conduct the activities required by the grant program. This limitation would be applicable to all awardees of the State Offices of Rural Health Grant Program. DATES: If you wish to comment on any portion of this notice, HRSA must receive comments by February 14, 2008. ADDRESSES: You may submit comments by any of the following methods: • *E-mail: kmidberry@hrsa.gov* . Include “State Offices of Rural Health Grant Program” in the subject line of the message. • *Mail:* Keith Midberry, Office of Rural Health Policy, Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Room 9A-42, Rockville, MD 20857. • *Hand Delivery/Courier:* Keith Midberry, Office of Rural Health Policy, Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Room 9A-42, Rockville, MD 20857. *Docket:* For access to the docket to read background documents or comments received, go to the Office of Rural Health Policy, Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Room 9A-42, Rockville, Maryland, 20857, weekdays between the hours of 8:30 a.m. and 5 p.m. To schedule an appointment to view public comments, phone

(301)443-2669. FOR FURTHER INFORMATION CONTACT: Keith Midberry, at the above address, telephone number 301-443-2669. SUPPLEMENTARY INFORMATION: The HRSA State Offices of Rural Health

(SORH)Grant Program is authorized by Section 338J of the Public Health Service Act (42 U.S.C. 254r). The purpose of the SORH grant program is to assist States in strengthening their rural health care delivery systems by helping to support a focal point for rural health within each State. The program provides funding for an institutional framework that links rural hospitals, providers and communities with State and Federal resources to help develop long term solutions to rural health problems. The law provides for a Federal-State partnership, requiring a State funding match of $3 for each $1 of Federal funding. Over the past 16 years, this program has leveraged in excess of $175 million in State matching funds for rural health. The average annual award for each State is $150,000. The SORH program issues one award to a single grantee from each of the 50 States. The law requires that the governor designate the entity that will serve as the State's SORH. Currently, 37 of the Offices are located in State health departments, 10 in academic settings (9 universities and 1 junior college) and 3 are non-profit organizations. Grant funds enable each State grantee to conduct the following activities:

(1)Establish and maintain within the State a clearinghouse for collecting and disseminating information on—

(A)Rural health care issues;

(B)Research findings relating to rural health care; and

(C)Innovative approaches to the delivery of health care in rural areas;

(2)Coordinate the activities carried out in the State that relate to rural health care, including providing coordination for the purpose of avoiding duplication in such activities;

(3)Identify Federal, State, and nongovernmental programs regarding rural health, and provide technical assistance to public and nonprofit private entities regarding participation in such programs;

(4)Encourage, but not directly fund, the recruitment and retention of health professionals in rural areas; and

(5)Assist in strengthening State, local and Federal partnerships in rural health. Since 2001, SORH grant guidance has limited indirect cost recovery to not more than 15 percent of the Federal award regardless of whether the grantee has a higher negotiated rate agreement. The grant program initiated this limitation on the recoverable indirect costs because some grantees are located within universities that have established indirect cost rate agreements in the range of 30 to 50 percent. In adhering to the existing GPD policy, as much as 50 percent of grants funds could be consumed for administrative and other purposes by the host institution, which would significantly reduce the amount of funds available to carry out the objectives of the authorizing legislation and grant program. Maintaining an indirect cost limitation will enable awardees to continue to invest 85 percent (or more) of their grant funds for activities that help improve health care in rural communities. Not restricting indirect cost recovery would reduce the amount of funds available to improve rural health care and erode sixteen years of SORH success. To maintain the limit on indirect costs in the 2008 grant funding opportunity guidance, a request to deviate from the Department of Health and Human Services

(DHHS)Grants Policy Directive

(GPD)3.01, Indirect Costs and Other Cost Policies was required. Such a request was submitted and approved by the HHS, Office of Grants Policy, Oversight and Evaluation, Assistant Secretary for Resources and Technology in November, 2007. Public Comment HRSA invites public comment on its intent to indefinitely limit indirect cost recovery to not more than 15 percent of the total allowable direct costs for awardees of the State Offices of Rural Health Grant Program. Dated: January 7, 2008. Elizabeth M. Duke, Administrator. [FR Doc. E8-551 Filed 1-14-08; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Fogarty International Center; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice if hereby given of a meeting of the Fogarty International Center Advisory Board. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* Fogarty International Center Advisory Board. *Date:* February 4-5, 2008. *Closed:* February 4, 2008, 2 p.m. to 4 p.m. *Agenda:* To review and evaluate grant applications and/or proposals. *Place:* National Institutes of Health, Lawton Chiles International House, Bethesda, MD 20892. *Closed:* February 5, 2008, 8:30 a.m. to 10:30 a.m. *Agenda:* To review and evaluate grant applications and/or proposals. *Place:* National Institutes of Health, Lawton Chiles International House, Bethesda, MD 20892. *Open:* February 5, 2008, 10:30 a.m. to 3:30 p.m. *Agenda:* Advisory Board Topics will include discussion of the five year strategic plan, as well as discussion on research challenges related to the rising prevalence of non-communicable diseases in low- and middle- income countries. Discussion will feature a recent Delphic analysis to identify key scientific questions and pursuits in non-communicable disease prevention and treatment in these regions. *Place:* National Institutes of Health, Lawton Chiles International House, Bethesda, MD 20892. *Contact Person:* Robert Eiss, Public Health Advisor, Fogarty International Center, National Institutes of Health, 31 Center Drive, Room B2C02, Bethesda, MD 20892,

(301)496-1415, *EISSR@MAIL.NIH.GOV* . Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit. Information is also available on the Institute's/Center's home page: *http://www.nih.gov/fic/about/advisory.html* , where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.106, Minority International Research Training Grant in the Biomedical and Behavioral Sciences; 93.154, Special International Postdoctoral Research Program in Acquired Immunodeficiency Syndrome; 93.168, International Cooperative Biodiversity Groups Program; 93.934, Fogarty International Research Collaboration Award; 93.989, Senior International Fellowship Awards Program, National Institutes of Health, HHS) Dated: January 8, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 08-99 Filed 1-14-08; 8:45 am]

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