Notices. Notice

3,718 words·~17 min read·/register/2007/10/30/07-5379

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BILLING CODE 4150-24-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007F-0368] Biomin GmbH; Filing of Food Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that Biomin GmbH, Industriestrasse 21, Herzogenburg, Austria 3130, has filed a petition proposing that the food additive regulations be amended to provide for the safe use of *Eubacterium* bacterial species in feed for detoxifying trichothecene mycotoxins in the digestive tracts of swine and poultry. DATES: Submit written or electronic comments on the petitioner's environmental assessment December 31, 2007. ADDRESSES: You may submit written comments 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: Isabel W. Pocurull, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6853, email: *isabel.pocurull@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5)), notice is given that a food additive petition (FAP No. 2256) has been filed by Betty J. Pendleton, 768 Arbor Court, Mobile, Alabama 36609, US agent for Biomin GmbH, Industriestrasse 21, Herzogenburg, Austria 3130. The petition proposes to amend the food additive regulations in part 573, Food Additives Permitted in Feed and Drinking Water of Animals (21 CFR part 573) to provide for the safe use of *Eubacterium* bacterial species in feed for detoxifying trichothecene mycotoxins in the digestive tracts of swine and poultry. The potential environmental impact of this action is being reviewed. To encourage public participation consistent with regulations issued under the National Environmental Policy Act (40 CFR 1501.4(b)), the agency is placing the environmental assessment submitted with the petition that is the subject of this notice on public display at the Division of Dockets Management (see ADDRESSES ) for public review and comment. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. FDA will also place on public display any amendments to, or comments on, the petitioner's environmental assessment without further announcement in the **Federal Register** . If, based on its review, the agency finds that an environmental impact statement is not required and this petition results in a regulation, the notice of availability of the agency's finding of no significant impact and the evidence supporting that finding will be published with the regulation in the **Federal Register** in accordance with 21 CFR 25.51(b). Dated: October 18, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7-21298 Filed 10-29-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0395] Draft Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft guidance for industry entitled “Acute Bacterial Sinusitis: Developing Drugs for Treatment.” The purpose of this guidance is to assist clinical trial sponsors and investigators in the development of antimicrobial drug products for the treatment of acute bacterial sinusitis (ABS). The agency's thinking in this area has evolved in recent years, and this draft guidance, when finalized, will inform sponsors of our current thinking in this area. In addition, it will fulfill a statutory requirement to publish such a guidance enacted in the Food and Drug Administration Amendments Act of 2007 (FDAAA). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 28, 2008. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance 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* or *http://www.regulations.gov* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Steve Gitterman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6134, Silver Spring, MD 20993-0002, 301-796-1600. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled “Acute Bacterial Sinusitis: Developing Drugs for Treatment.” The purpose of this guidance is to assist clinical trial sponsors and investigators in the development of antimicrobial drug products for the treatment of ABS. This guidance revises the draft guidance regarding ABS published in 1998. Section 911 of the FDAAA (Public Law 110-85) adds section 511 to the Federal Food, Drug, and Cosmetic Act that directs the Secretary for Health and Human Services to “issue guidance for the conduct of clinical trials with respect to antibiotic drugs, including antimicrobials to treat acute bacterial sinusitis.” This guidance will fulfill this statutory requirement. The design of clinical trials for ABS was the subject of an Anti-Infective Drug Products Advisory Committee meeting on October 28, 2003. In addition, other advisory committee meetings have focused on the development of specific drug products for this indication. As a result of these public discussions, as well as review of pending applications at FDA, the agency's thinking in this area has evolved in recent years, and this guidance informs sponsors of the changes in our recommendations. Specifically, this guidance recommends that ABS clinical trials be designed as superiority rather than noninferiority trials, and discusses some possible study designs that might be employed in an ABS trial designed to show superiority. This guidance also recommends that microbiological information be obtained in at least one of the controlled studies. This guidance discusses patient-reported outcome instruments for assessing clinical response, and the use of time to resolution as a possible approach to assessing the primary endpoint. As required by FDAAA, this guidance also addresses the use of animal models and surrogate markers in the development of drugs for the treatment of ABS. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on developing drugs for the treatment of acute bacterial sinusitis. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001; and the collections of information referred to in the guidance entitled “Establishment and Operation of Clinical Trial Data Monitoring Committees” have been approved under OMB control number 0910-0581. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the document at either *http://www.fda.gov/cder/guidance/index.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: October 24, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-21332 Filed 10-29-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Privacy Act of 1974: New System of Records AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Notification of new system of records. SUMMARY: In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration

(HRSA)is publishing a notice of a proposal to add a new system of records. The Campus Based Branch

(CBB)of the Division of Health Careers Diversity and Development in the Bureau of Health Professions is currently utilizing a document management system

(DMS)that dynamically manages its flow of documents produced and received. the DMS is an intra-office system in which documents contained within the system are only shared among CBB staff. The DMS contains names and other personally identifiable information of borrowers. DATES: HRSA invites interested parties to submit comments on the proposed New System of Records on or before December 10, 2007. HRSA has sent a report of a New System of Records to Congress and to the Office of Management and Budget

(OMB)on October 18, 2007. The New System of Records will be effective 40 days from the date submitted to OMB unless HRSA comments which would result in a contrary determination. ADDRESSES: Please address comments to Donn Taylor, Health Resources and Services Administration, Privacy Act Coordinator, 5600 Fishers Lane, Room 14A-20, Rockville, Maryland 20857; Telephone

(301)443-0204. Comments received will be available for inspection at this same address from 9 a.m. to 3 p.m., Monday through Friday. this is not a toll-free number. FOR FURTHER INFORMATION CONTACT: Henry Lopez, Director, division of Health Careers diversity and Development, Bureau of Health Professions, 5600 Fisher Lane, Room 8-42, Rockville, Maryland 20857; Telephone 301-443-1173. This is not a toll-free number. SUPPLEMENTARY INFORMATION: The Health Resources and Services Administration proposes to establish a New System of Records: “Campus Based Branch Programs Document Management System, HHS/HRSA/BHPr.” The CBB programs which use the DMS are authorized by the following sections of the Public Health Service Act: Section 721 of the Public Health Service Act (42 U.S.C. 292q) the Health Professions Student Loan Program; Section 724 of the Public Health Service Act (42 U.S.C. 292s) the Primary Care Loan Program; Section 724 of the Public Health Service Act (42 U.S.C. 292t) the Loans for Disadvantaged Students Program; Section 835 of the Public Health Service Act (42 U.S. C. 297a) the Nursing Student Loan Program; and Section 737 of the Public Health Service Act (42 U.S.C. 293a) the Scholarships for Disadvantaged Students Program. In accordance with their applicable regulations, the funds appropriated or distributed from these CBB programs are monitored by the CBB. The DMS is an automated system that enables CBB to fulfill its duty in monitoring these programs. The DMS contains annual operating and performance data from educational institutions participating in CBB programs, as well as personally identifiable information of borrowers. Dated: October 12, 2007. Elizabeth M. Duke, Administrator. Report of a New System of Records 09-15-0069 SYSTEM NAME: Campus Based Branch

(CBB)Program Document Management System (DMS), HHS/HRSA/BHPr. SECURITY CLASSIFICATION: None SYSTEM LOCATION: The Division of Health Careers Diversity and Development (DHCDD) of the Bureau of Health Professions (BHPr), Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). Records are located at 5600 Fishers Lane, Room 8-42, Rockville, MD 20857. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: Student and faculty borrowers who participate/participated in CBB loan and scholarship programs. CATEGORIES OF RECORDS IN THE SYSTEM: The systems include materials such as: 1. Names, addresses, phone numbers, medical records, financial information, and social security numbers of borrowers. 2. Annual Operating Reports that contain financial information from institutions, including aggregate amounts of loans disbursed, collected and retired. 3. Performance reports on the aggregate number of borrowers, their classification in race/ethnicity categories, and whether they are practicing in primary care. 4. Contact information of financial aid officers that include name, title, school address and direct phone number. 5. Correspondence from the financial aid officers regarding issues with specific borrowers. The majority of these correspondence only indicate the borrower's name and/or amount borrowed. 6. Correspondence from borrowers on specific issues on CBB programs or the school that administers the programs. These correspondences may include the borrower's name, address and phone number. 7. Case reports from educational institutions on borrowers whom the school is claiming an uncollectible debt or a total disability write-off. The documents contained in these case reports may include name, address, financial income information, medical records and social security numbers. 8. Any other correspondence or documentation related to general or specific issues regarding CBB programs at institutions or borrowers who participate in CBB programs. AUTHORITY FOR MAINTENANCE OF SYSTEM: Section 721 of the Public Health Service Act (42 U.S.C. 292q), Health Professions Student Loan; Section 835 of the Public Health Service Act (42 U.S.C. 297a), Nursing Student Loan; Section 723 of the Public Health Service Act (42 U.S.C. 292s), Primary Care Loan; Section 724 of the Public Health Service Act (42 U.S.C. 292t), Loans for Disadvantaged Students; Section 737 of the Public Health Service Act (42 U.S.C. 293a), Scholarships for Disadvantaged Students. PURPOSE(s): The purpose of the DMS system is to support the CBB in monitoring its programs, in order to ensure the efficiency of the factual information in reports and documents, and to archive the documents for efficient access and verification. ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES: Records maintained in the system above, disclosure of which is governed by the System of Records Notice for the “Campus Based Branch Program Document Management System, HHS/HRSA/BHPr” may be disclosed to others: 1. HRSA may disclose records to Department contractors and subcontractors for the purpose of assisting CBB in reviewing cases and maintaining systems, including conducting data analysis for program evaluations, compiling managerial and statistical reports, and record systems processing and refinement. Contractors will maintain, and are also required to ensure that subcontractors maintain, Privacy Act safeguards with respect to such records. 2. Disclosure may be made to a Congressional office from the record of an individual or institutional participant, in response to any inquiry from the Congressional office made at the request of that individual. 3. Disclosure may be made to the Department of Justice, or to a court or other tribunal, from this system of records, when

(a)HHS, or any component thereof; or

(b)any HHS employee in his or her official capacity; or

(c)any HHS employee in his or her individual capacity where the Department of Justice (or HHS, where it is authorized to do so) has agreed to represent the employee; or

(d)the United States or any agency thereof, where HHS determines that the litigation is likely to affect HHS or any of its components, is a party to litigation or has an interest in such litigation, and HHS determines that the use of such records by the Department of Justice, the court or other tribunal is relevant and necessary to the litigation and would help in the effective representation of the governmental party, provided, however, that in such case HHS determines that such disclosure is compatible with the purpose for which the records were collected. 4. In the event that a system of records maintained by this agency to carry out its functions indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature and whether arising by general statute or particular program statute, or by regulation, rule, or order issued pursuant thereto, the relevant records in the system of records may be referred to the appropriate agency, whether Federal, State or local, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute or rule, regulation or order issued pursuant thereto. 5. HRSA may disclose from this system of records a delinquent debtor's name, address, Social Security number, and other information necessary to identify him/her; the amount, status, and history of the claim, and the agency or program under which the claim arose, to the Treasury Department, Internal Revenue Service (IRS), to request a debtor's current mailing address to locate him/her for purposes of collecting a debt. This address may be disclosed by HRSA to any school from which the defaulted borrower received the student loan, for use only by officers, employees, or agents of the school whose duties relate to the collection of health professions or nursing student loan funds, to locate the defaulted borrower to collect the loan. Any school which requests and obtains this address information must comply with the requirements of HRSA and the IRS regarding the safeguarding and proper handling of this information. STORAGE: Records are maintained in the DMS or in file folders and/or computer data files. RETRIEVABILITY: Retrieval of data and case files is by subject's name or institution ID. SAFEGUARDS: 1. Authorized users: Access is limited to authorized HHS staff in performance of their duties. Authorized personnel include the contractor/system manager and his staff who have responsibilities for administering the programs. HRSA maintains current lists of authorized users. Educational institutions may request or access information they submitted to CBB. However, they do not have access to information submitted by other institutions. 2. Physical safeguards: The DMS is housed on a HRSA server behind a firewall. The DMS is an intra-office system only for the sole use of CBB staff. All computer equipment and files and hard copy files are stored in areas where fire and life safety codes are strictly enforced. All automated and non-automated documents are protected on a 24-hour basis. Perimeter security includes intrusion alarms, on-site guard force, random guard patrol, key/passcard/combination controls, and receptionist controlled area. Hard copy files are maintained in a file room used solely for this purpose with access limited by combination lock to authorized users identified above. Computer files are password protected and are accessible only by use of computers which are password protected. 3. Procedural safeguards: A password is required to access computer files. All users of personal information in connection with the performance of their jobs protect information from public view and from unauthorized personnel entering an unsupervised area. All passwords, keys and/or combinations are changed when a person leaves or no longer has authorized duties. Access to records is limited to those authorized personnel trained in accordance with the Privacy Act and ADP security procedures. The safeguards described above were established in accordance with DHHS chapter 45-13 and supplementary chapter PHS hf: 45-13 of the General Administration Manual; and the DHHS Information Resources Management Manual, Part 6, “ADP Systems Security.” RETENTION AND DISPOSAL: Records in the DMS are retained for at least 6 years after full payment of the loan, completion of service obligation, or repayment to the Secretary in the case of a default. Contact the System Manager at the following address for further information. SYSTEM MANAGERS(s) AND ADDRESS: Director, Division of Health Careers Diversity and Development, Bureau of Health Professions, Health Resources and Services Administration, Department of Health and Human Services, 5600 Fishers Lane, Room 8-42, Rockville, Maryland 20857. NOTIFICATION PROCEDURE: Requests concerning whether the system contains records about you should be made to the Systems Manager. REQUESTS IN PERSON: A subject individual who appears in person at a specific location seeking access or disclosure of records relating to him/her shall provide his/her name, current address, Social Security number and at least one piece of tangible identification such as driver's license, passport, voter registration card, or union card. Identification papers with current photographs are preferred but not required. Additional identification may be requested when there is a request for access to records which contain an apparent discrepancy between information contained in the records and that provided by the individual requesting access to the records. Where the subject individual has no identification papers, the responsible agency official shall require that the subject individual certify in writing that he/she is the individual who he/she claims to be and that he/she understands that the knowing and willful request or acquisition of a record concerning an individual under false pretenses is a criminal offense subject to a $5,000 fine. REQUESTS BY TELEPHONE: Because positive identification of the caller cannot be established, no requests by telephone will be honored. REQUESTS BY MAIL: A written request must contain the name and address of the requester, Social Security number or other identifying numbers, and his/her signature which is either notarized to verify his/her identify or includes a written certification that the reqeuster is a person he/she claims to be and that he/she understands that the knowing and willful request or acquisition of records pertaining to an individual under false pretenses is a criminal offense subject to a $5,000 fine. RECORD ACCESS PROCEDURES: Same as notification procedures. Requesters should also reasonably specify the record contents being sought. Individuals may also request an accounting of disclosures that may have been made of their records, if any. CONTESTING RECORD PROCEDURES: Any record subject may contest the accuracy of information on file at CBB by writing to the Director, Division of Health Careers Diversity and Development, Bureau of Health Professions, Health Resources and Services Administration, Department of Health and Human Services, 5600 Fishers Lane, Room 8-42, Rockville, Maryland 20857. The request should contain a reasonable description of the record, specify the information being contested, the corrective action sought, and the reasons for requesting the correction, along with supporting information to show how the record is inaccurate, incomplete, untimely or irrelevant. RECORD SOURCE CATEGORIES: 1. Educational institutions participating in CBB programs 2. Financial aid officers administering CBB programs 3. Student borrowers and recipients participating in CBB programs 4. Borrowers submitted for uncollectible debt write-offs 5. Borrowers submitted for total disability write-offs SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. 07-5379 Filed 10-29-07; 8:45 am]

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