Department of Health and Human Services 2007 – Federal Register Recent Federal Regulation Documents

This notice is hereby given that awards will be made to eleven unaccompanied alien shelter care providers in the amount of $10,633,009. This funding will support services through September 30, 2007.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open to the public on both Wednesday, August 22 and Thursday, August 23, 2007.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Health Resources and Services Administration published a document in the Federal Register of June 20, 2007. The document pertaining to the HRSA Information Center (IC) entitled ``Privacy Act of 1974: New System of Record'' Integrated Clearinghouse System (ICS), HHS/HRSA/OC No. 09-15-0067, was inadvertently omitted as the attachment for the notice.

The Food and Drug Administration (FDA) has determined that methotrexate injection, USP, preservative free, equivalent to (Eq.) 500 milligrams (mg) base/20 milliliters (mL) (25 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for methotrexate injection, preservative free, Eq. 500 mg base/20 mL (25 mg/mL).

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay,'' dated August 2007. The guidance document provides a means by which in vitro human immunodeficiency virus (HIV) drug resistance genotype assays may comply with special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule classifying the in vitro HIV drug resistance genotype assay into class II (special controls). The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays: Special Controls'' dated August 2001.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes'' dated July 2007. The guidance document provides recommendations to manufacturers of HBsAg assays that are intended to test donors of Whole Blood and blood components, including Source Plasma and Source Leukocytes, and to establishments using an HBsAg assay. Topics include recommendations on minimum sensitivity standards for HBsAg assays. This guidance finalizes the draft guidance entitled ``Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components, and Source Plasma Donations'' dated April 2002.

A notice was published in the Federal Register (FR) on February 13, 2007, (Vol. 72, p. 6738-6739), describing HRSA's proposal to institute an exception to the Department of Health and Human Services' policy directive governing indirect cost recovery. The notice requested public comments on the proposed exception to Departmental policy requirements to be sent to HRSA no later than March 15, 2007. Three comments were received, one from a Poison Control Center (PCC) host institution (grant recipient) and two from individual PCCs. Two of the three commenters supported HRSA's plan to institute an exception from the grants policy directive, which would permanently limit indirect cost recovery to 10 percent for the Poison Control Center Stabilization and Enhancement Grant Programs.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

This notice with comment period describes the criteria we intend to use to evaluate the efficiency and effectiveness of Quality Improvement Organizations (QIOs) currently under contract with CMS in accordance with the Social Security Act. These evaluation criteria are based on the tasks and related subtasks set forth in the QIO's Scope of Work (SOW). The current 8th SOW includes Tasks 1, 3, and 4 (Task 2 is reserved) with subtasks included under Tasks 1 and 3. QIOs were awarded contracts for the 8th SOW, or 8th Round, for 3 years, with staggered starting dates beginning August 2005, November 2005, and February 2006. Comments on this notice will also be considered in the development of the 9th SOW.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Healthcare Common Procedure Coding System (HCPCS) Level II, System No. 09-70- 0576.'' In October 2003, the Secretary of HHS delegated authority under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to CMS to maintain and distribute HCPCS Level II Codes. Level II of the HCPCS is a standardized coding system that is used primarily to identify products and services not included in the HCPCS Level I Current Procedural Terminology (CPT) codes, such as: Injectable drugs administered in a physician office; durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) when used outside a physician's office; and ambulance services. HCPCS Level II codes were established to identify these products on insurance claims. There are about 4000 HCPCS Level II codes available for assignment by insurers in accordance with their policies. The primary purpose of this system is to facilitate the management and maintenance of the HCPCS Level II code set. Information in this system will also be used to: (1) Support regulatory and policy functions performed within the Agency or by a contractor, consultant, or grantee; (2) assist another Federal or state agency; (3) support litigation involving the Agency related to this system; and (4) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the proposed system in the Supplementary Information section below. Although the Privacy Act requires only that the ``routine use'' portion of the system be published for comment, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for ACTIQ (fentanyl), ALDARA (imiquimod), AMBIEN (zolpidem), COREG (carvedilol), PROVIGIL (modafinil), and ZYPREXA (olanzapine). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at W.R. Grace, Erwin, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 22, 2007, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

This final rule will update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2008 (for discharges occurring on or after October 1, 2007 and on or before September 30, 2008) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each fiscal year, the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year. We are revising existing policies regarding the PPS within the authority granted under section 1886(j) of the Act.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) has determined that PHENERGAN (promethazine hydrochloride (HCl)) suppositories, 12.5 milligrams (mg) and 25 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for promethazine HCl suppositories, 12.5 mg and 25 mg.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.'' This guidance document describes a means by which the absorbable poly(hydroxybutyrate) surgical suture produced by recombinant deoxyribonucleic acid (DNA) technology may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify these device types into class II (special controls).

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the renewal of the generic information collection project: ``Voluntary Customer Surveys Generic Clearance for the Agency for Healthcare Research and Quality'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Bayer HealthCare LLC. The NADA provides for veterinary prescription use of an emodepside and praziquantel topical solution on cats for the treatment and control of infections by several internal parasites.

This proposed rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes would be applicable to services furnished on or after January 1, 2008. In addition, this proposed rule would update the revised Medicare ambulatory surgical center (ASC) payment system to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). In this proposed rule, we propose the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which the final policies of the ASC payment system would apply, and other pertinent ratesetting information for the CY 2008 ASC payment system. These changes would be applicable to services furnished on or after January 1, 2008. In this proposed rule, we also are proposing changes to the policies relating to the necessary provider designations of critical access hospitals (CAHs) that are being recertified when a CAH enters into a new co-location arrangement with another hospital or CAH or when the CAH creates or acquires an off-campus location. Further, we are proposing changes to several of the current conditions of participation that hospitals must meet to participate in the Medicare and Medicaid programs to require the completion and documentation in the medical record of medical histories and physical examinations of patients conducted after admission and prior to surgery or a procedure requiring anesthesia services and for postanesthesia evaluations of patients before discharge or transfer from the postanesthesia recovery area.

Notice is hereby given of a preliminary determination that funds from the fiscal year (FY) 2006 Low Income Home Energy Assistance Program (LIHEAP) are available for reallotment to States, Territories, and Tribes and Tribal Organizations that receive FY 2007 direct LIHEAP grants. No subgrantees or other entities may apply for these funds. Section 2607(b)(1) of the Low Income Home Energy Assistance Act (the Act), Title XXVI of the Omnibus Budget Reconciliation Act of 1981 (42 U.S.C. 8621 et seq.), as amended, requires that if the Secretary of the Department of Health and Human Services (HHS) determines that, as of September 1 of any fiscal year, an amount in excess of certain levels allotted to a grantee for any fiscal year will not be used by the grantee during the fiscal year, the Secretary must notify the grantee and publish a notice in the Federal Register that such funds may be realloted to LIHEAP grantees during the following fiscal year. If reallotted, the LIHEAP block grant allocation formula will be used to distribute the funds. (No funds may be allotted to entities that are not direct LIHEAP grantees during FY 2007.) It has been determined that $326,894 may be available for reallotment during FY 2007. This determination is based on revised Carryover and Reallotment Reports from the Turtle Mountain Band of Chippewa Indians in North Dakota and Southern Ute Indian Tribe in Colorado, which were submitted to the Office of Community Services as required by 45 CFR 96.82. The statute allows grantees who have funds unobligated at the end of the fiscal year for which they are awarded to request that they be allowed to carry over up to 10 percent of their allotments to the next fiscal year. Funds in excess of this amount must be returned to HHS and are subject to reallotment under section 2607(b)(1) of the Act. The amount described in this notice was reported as unobligated FY 2006 funds in excess of the amount that the Turtle Mountain Band of Chippewa Indians could carry over to FY 2007. Additionally, an amount from Southern Ute Indian Tribe is excess funds for FY 2006 plus the 10 percent carryover, since the tribe did not apply for FY 2007 LIHEAP funds. The Turtle Mountain Band of Chippewa Indians was notified by certified mail that $297,492 of its FY 2006 funds may be reallotted. Additionally, the Southern Ute Indian Tribe was notified by certified mail that $29,402 of its FY 2006 funds may be reallotted. In accordance with section 2607(b)(3), the Chief Executive Officers of both the tribes have 30 days from the date of the letter to submit comments to: Josephine B. Robinson, Director, Office of Community Services, 370 L'Enfant Promenade, SW., Washington, DC 20447. The comment period expires August 31, 2007. After considering any comments submitted, the Chief Executive Officers will be notified of the final reallotment amount, and this decision also will be published in the Federal Register. If funds are reallotted, they will be allocated in accordance with section 2604 of the Act and must be treated by LIHEAP grantees receiving them as an amount appropriated for FY 2007. As FY 2007 funds, they will be subject to all requirements of the Act, including section 2607(b)(2), which requires that a grantee obligate at least 90 percent of its total block grant allocation for a fiscal year by the end of the fiscal year for which the funds are appropriated, that is, by September 30, 2007.

Consistent with section 4312(a) of the Balanced Budget Act of 1997 (BBA), this proposed rule implements section 1834(a)(16)(B) of the Social Security Act (the Act) by requiring all Medicare suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) to furnish CMS with a surety bond. We believe that this requirement would limit the Medicare program risk to fraudulent DME suppliers; enhance the Medicare enrollment process to help ensure that only legitimate DME suppliers are enrolled or are allowed to remain enrolled in the Medicare program; ensure that the Medicare program recoups erroneous payments that result from fraudulent or abusive billing practices by allowing CMS or its designated contractor to seek payments from a Surety up to the penal sum; and help ensure that Medicare beneficiaries receive products and services that are considered reasonable and necessary from legitimate DME suppliers.

The Food and Drug Administration (FDA) is amending the animal drug regulations for food substances affirmed as generally recognized as safe (GRAS) in feed and drinking water of animals to correct a cross-reference. This action is being taken to improve the accuracy of the regulations.

The NTP announces the availability of the draft background documents for captafol and ortho-nitrotoluene on August 1, 2007, from the RoC Web site (https://ntp.niehs.nih.gov/go/10091 see captafol or ortho-nitrotoluene) or in printed text from the RoC (see FOR FURTHER INFORMATION CONTACT below). The NTP invites the submission of public comments on the two draft background documents (see SUPPLEMENTARY INFORMATION below). The expert panel will meet on October 15-16, 2007, at the Sheraton Chapel Hill Hotel, Chapel Hill, North Carolina, to peer review the draft background documents for captafol and ortho- nitrotoluene and once completed make a recommendation regarding the listing status (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) for captafol and ortho-nitrotoluene in the 12th Edition of the RoC (12th RoC). The RoC expert panel meeting is open to the public with time scheduled for oral public comments. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the NTP will post the final version of the background documents and the expert panel peer review reports on the RoC Web site.

The Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services (HHS) is issuing this Advance Notice of Proposed Rulemaking (ANPRM) to begin the process of revising the regulations that cover the importation of dogs and cats (42 CFR 71.51), including by extending these regulations to cover domesticated ferrets. This ANPRM will also address the importation of African rodents (42 CFR 71.56) into the United States. HHS/CDC is also considering the need for additional regulations to prevent the introduction of zoonotic diseases into the United States. The input received from stakeholders and other interested parties via the ANPRM process will lead to a Notice of Proposed Rulemaking (NPRM), with the aim of improving HHS's ability to prevent importation of communicable diseases into the United States. The scope of this ANPRM does not include the non-human primate regulations (42 CFR 71.53).

This notice announces the seventh meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

The Centers for Medicare & Medicaid Services CMS inadvertently published a new system of records titled ``Post Acute Care Payment Reform/Continuity of Assessment Report and Evaluation Demonstration and Evaluation (PAC-CARE)'' System No. 09-70-0569 in the Federal Register (FR) on Thursday, April 19, 2007 (72 FR 19711). CMS is withdrawing the notice due to comments received that a routine use disclosure provision necessary to carry out essential parts of the demonstration project was inadvertently omitted. The notice of a new system of records will be republished at a later date with the routine use included.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Lawrence Livermore National Laboratory, Livermore, California, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Lawrence Livermore National Laboratory. Location: All areas. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1950 through December 31, 1973.

In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13) and Office of Management and Budget (OMB) regulations at 5 CFR Part 1320 (60 FR 44978, August 29, 1995), this notice announces the intention of the Department of Bioethics, National Institutes of Health (NIHDCB) to request approval for a new information collection, Physicians' Experience of Ethical Dilemmas and Resource Allocation. The proposed information collection was previously published in the Federal Register on May 17, 2007, on pages 27817-18 and allowed 60-days for public comment. Two public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Physicians' Experience of Ethical Dilemmas and Resource Allocation. Type of Information Collection Request: New. Need and Use of Information Collection: Health care costs are rising ceaselessly and there are currently no generally accepted way of controlling them. This study will access the experience of physicians regarding resource allocation in clinical practice, and how allocation decisions made at other levels shapes this experience. The primary objectives of the study are to determine if physicians make decisions to withhold interventions on the basis of cost, how often they report doing so, what types of care are withheld, and what criteria are used in making such decisions. The findings will provide valuable information concerning: (1) The practice of resource allocation in clinical practice, (2) the possible effects of perceived constraints on this practice; and (3) international comparisons on these two aspects. Frequency of Response: Once. Affected Public: Individuals or households; Businesses or other for-profit; Not-for- profit institutions. Type of Respondents: Physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 250; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 0.3674; and Estimated Total Annual Burden Hours Requested: 91.85. The annualized cost to respondents is estimated at: $5,218. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Marion Danis, Department of Bioethics, DCB, CC, NIH, Building 10, Room 1C 118, 9000 Rockville Pike, Bethesda, MD 20892-1156, or call non-toll-free number 301-435-8727 or e-mail your request, including your address to: mdanis@cc.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

This notice announces an administrative hearing to be held on September 4, 2007, at 150 S. Independence Mall West, Suite 216, Conference Room 241, Pennsylvania Room, The Public Ledger Building, Philadelphia, PA 19106-3499, to reconsider CMS' decision to disapprove Virginia's title XXI SPA No. 6. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by (15 days after publication).

Attached is the proposed Research Plan for the National Children's Study (NCS). The purpose of this notice is to inform scientific reviewers, professional colleagues, contributors, and all who are interested in this ground-breaking initiative, of the opportunity for review and comment. The Research Plan describes the Study's background, design, measures, and the rationale for their selections in sufficient detail so that readers can understand the basis of the Study and how it will be carried out. This plan was developed with input from scientists and other professionals across the country and from multiple federal agencies, especially the National Institute of Child Health and Human Development (NICHD) and the National Institute of Environmental Health Sciences (NIEHS) at the National Institutes of Health (NIH), the Centers for Disease Control and Prevention, and the U.S. Environmental Protection Agency (EPA). We welcome constructive comments and proposals for how the National Children's Study might address the pressing health concerns of our nation's children even more effectively. Procedures for commenting and communicating about the Research Plan are found on the NCS Web site at: https://www.nationalchildrensstudy.gov/research/researchplan/ index.cfm.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This proposed notice with comment period acknowledges the receipt of a deeming application from the American Osteopathic Association (AOA) for continued recognition as a national accrediting organization for Critical Access Hospitals (CAH) that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act (the Act) requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

This notice invites all organizations representing physicians to submit nominations for consideration to fill four seats on the Practicing Physicians Advisory Council (the Council) that will be vacated by current Council members in 2008. This notice also announces a quarterly meeting of the Council. The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance entitled ``In Vitro Diagnostic Multivariate Index Assays.'' FDA is issuing this revised draft guidance to address the definition and regulatory status of a class of In Vitro Diagnostic Devices referred to as In Vitro Diagnostic Multivariate Index Assays (IVDMIAs). The revised draft guidance also addresses premarket and postmarket requirements with respect to IVDMIAs. The initial draft of this guidance was issued September 7, 2006.

Section 301(f) of the United States Leadership Against HIV/ AIDS, Tuberculosis and Malaria Act of 2003 (the ``Leadership Act''), P.L. No. 108-25 (May 27, 2003), 22 U.S.C. 7631(f), prohibits the award of grants, contracts or cooperative agreements for activities funded under the Act to any organization that does not have an explicit policy opposing prostitution and sex trafficking. Section 301(f) states as follows:

In compliance with the requirement of Section 3507(A)(1)(D) of the Paperwork Reduction Act of 1995 for the opportunity for pubic comment on the proposed data collection projects, the Clinical Center (CC) of the National Institutes of Health, (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 9, 2007 (Volume 72, page 26400-26401) and allowed 60- days for public comments. One comment regarding resources required to conduct surveys was received during the 60-day comment period. The purpose of this notice is to provide an additional 30 days for public comment. 5 CFR 1320.5 Respondents to this request for information collection should not respond unless the request displays a currently valid OMB control number. Proposed Collection: Title: Generic Clearance for Satisfaction Surveys of Customer and Other Partners. Type of Information Collection Request: Reinstatement (OMB Control Number: 0925-0458). Need and Use of Information Collection: The information collected in these surveys will be used by Clinical Center personnel: (1) To evaluate the satisfaction of various Clinical Center customers and other partners with Clinical Center services; (2) to assist with the design of modifications of these services, based on customer input; (3) to develop new services, based on customer need; and 4) to evaluate the satisfaction of various Clinical Center customers and other partners with implemented service modifications. These surveys will almost certainly lead to quality improvement activities that will enhance and/or streamline the Clinical Center's operations. The major mechanisms by which the Clinical Center will request customer input is through surveys and focus groups. The surveys will be tailored specifically to each class of customer and to that class of customer's needs. Surveys will either be collected as written documents, as faxed documents, mailed electronically or collected by telephone from customers. Information gathered from these surveys of Clinical Center customers and other partners will be presented to, and used directly by, Clinical Center management to enhance the services and operations of our organization. Frequency of Response: The participants will respond yearly. Affected public: Individuals and households, businesses and other for profit, small businesses and organizations. Types of respondents: These surveys are designed to assess the satisfaction of the Clinical Center's major internal and external customers with the services provided. These customers include, but are not limited to, the following groups of individuals: Clinical Center patients, family members of Clinical Center patients, visitors to the Clinical Center, National Institutes of Health investigators, NIH intramural collaborators, private physicians or organizations who refer patients to the Clinical Center, volunteers, vendors and collaborating commercial enterprises, small businesses, regulators, and other organizations. The annual reporting burden is as follows:

Proposals to conduct research involving the deliberate transfer of a chloramphenicol resistance trait to Rickettsia typhi and conorii has been submitted to the NIH Office of Biotechnology Activities (OBA). The acquisition of this antibiotic resistance trait could possibly compromise the use of a class of antibiotics for the treatment of Rickettsia infections in humans. Under the NIH Guidelines, these experiments can proceed only after they are reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and specifically approved by the NIH Director as Major Actions. These proposals will be discussed at the September 17-19, 2007 RAC meeting.

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) and certain device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

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.

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: James David Lieber, University of California at Los Angeles: Based on the findings of an inquiry report by the University of California at Los Angeles (UCLA) and additional analysis and information obtained by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that James David Lieber, Staff Research Associate, Semel Institute for Neuroscience and Human Behavior, Integrated Substance Abuse Programs, UCLA, engaged in research misconduct in research funded by National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), grant R01 DA15390. Mr. Lieber knowingly and intentionally falsified and fabricated multiple follow-up interviews, urine samples, and urine sample records of human subject study participants and entered such false and fabricated data into the study's data base. A total of 914 follow-up interviews of opiate users were planned to be completed as part of a study of gender differences in a follow up of opiate users in California. Mr. Lieber was assigned to interview 53 of the 132 subjects located for the follow-up study. Over a six-month period, Mr. Lieber falsely claimed to have conducted face-to-face interviews for the study while subsequent contacts with the subjects revealed that they had not been interviewed for the study. A review by the institution determined that the respondent fabricated interviews for 20 of the 53 interviews assigned to him. In addition, he falsified the urine specimens for those 20 subjects and caused the entry of false information into the study tracking and locating data base for 11 subjects. Aggravating factors included the theft of $5180 for incentive payments to subjects and travel expenses. ORI has implemented the following administrative actions for a period of three (3) years, beginning on July 2, 2007: (1) Mr. Lieber is debarred from eligibility for any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' as defined in HHS' implementation of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension at 2 CFR part 376, et seq.; and (2) Mr. Lieber is prohibited from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed collection of information concerning cooperative manufacturing arrangements for licensed biologics.