Department of Health and Human Services August 2009 – Federal Register Recent Federal Regulation Documents

HHS proposes to revise the Privacy Act exempt system of records 09-37-0021, entitled ``Public Health Service Records Related to Inquiries and Investigations of Scientific Misconduct, HHS/OASH/ORI.'' This system became effective on August 29, 1994 (59 FR 36717, July 19, 1994). Changes were made in response to comments received, and the revised systems notice was published on January 6, 1995 (60 FR 2140). The proposed revisions include changing the routine uses and changing the title of the system to ``HHS Records Related to Research Misconduct Proceedings, HHS/OS/ORI.'' The revisions are necessary to reflect the changes made by the Public Health Service Policies on Research Misconduct (``PHS Policies on Research Misconduct''), 42 CFR Part 93 (``Part 93''), and to update the system to reflect current practices and procedures under that regulation.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/002,514, filed on August 18, 1995, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206- 1995/0-US-01); U.S. Patent Application No. 60/002,936, filed on August 30, 1995, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/1-US-01); U.S. Patent Application No. 60/ 013,172, filed on March 12, 1996, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/2-US-01); PCT Application No. PCT/US96/13286, filed on August 16, 1996, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206- 1995/3-PCT-01); Australian Patent No. 710662, issued on October 5, 2000, entitled ``Functional Role of Adrenomedullin (AM) and the Gene- Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/3-AU-02); Canadian Patent Application No. 2229741, filed on August 16, 1996, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/3-CA-03); U.S. Patent No. 6,320,022, issued on November 20, 2001, entitled ``Adrenomedullin Peptides'' (HHS Reference No. E-206-1995/3-US-04); European Patent No. 0845036, issued on June 2, 1999, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206- 1995/3-EP-07), and validated in France, Germany, and the United Kingdom; Japanese Patent Application No. 509499/97, filed on August 16, 1996, entitled ``Functional Role of Adrenomedullin (AM) and the Gene- Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/3-JP-09); U.S. Patent No. 7,101,548, issued on September 5, 2006, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/3-US-10); U.S. Patent Application No. 11/ 517,599, filed on September 5, 2006, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/3-US-11); Japanese Patent No. 4077861, issued on February 8, 2008, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206- 1995/3-JP-12); U.S. Patent Application No. 60/153,397, filed on September 10, 1999, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256-1999/0-US-01); PCT Application No. PCT/US00/24722, filed on September 8, 2000, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256-1999/0-PCT-02); Australian Patent No. 774725, issued on May 25, 2004, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E- 256-1999/0-AU-03); Canadian Patent Application No. 2383419, filed on September 8, 2000, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256-1999/0-CA-04); European Patent No. 1214600, issued on December 21, 2005, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E- 256-1999/0-EP-05), and validated in France, Germany, the United Kingdom, Italy, Spain, and Portugal; U.S. Patent Application No. 10/ 070,853, filed on March 8, 2002, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256 091999/0-US-06); U.S. Patent Application No. 11/ 530,411, filed on September 8, 2006, entitled ``Determination of AM- Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256-1999/0-US-13); U.S. Patent Application No. 12/ 236,418, filed on September 23, 2008, entitled ``Determination of AM- Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256-1999/0-US-14); U.S. Patent Application No. 60/ 425,018, filed on November 7, 2002, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294- 2002/0-US-01); PCT Application No. PCT/US03/35633, filed on November 7, 2003, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-PCT-02); U.S. Patent No. 7,462,593, issued on December 9, 2008, entitled ``Compositions and Methods for Promoting Angiogenesis'' (HHS Reference No. E-294-2002/0- US-03); European Patent Application No. 03786608.4, filed on November 7, 2003, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-EP-04); Australian Patent Application No. 2003295422, filed on April 18, 2005, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-AU-05); Canadian Patent Application No. 2504953, filed on November 7, 2003, entitled ``A New Target for Angiogenesis and Anti- Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-CA-06); Japanese Patent Application No. 2004-551922, filed on May 9, 2005, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-JP-07); U.S. Patent Application No. 12/ 240,656, filed on September 29, 2008, entitled ``Target for Anti- Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-US-08); U.S. Patent Application No. 60/500,650, filed on September 8, 2003, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/0-US-01); PCT Application No. PCT/US04/29293, filed on September 8, 2004, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-PCT-01); European Patent Application No. 04783513.7, filed on September 8, 2004, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-EP-03); Canadian Patent Application No. 2539467, filed on September 8, 2004, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-CA-04); Australian Patent Application No. 2004273057, filed on September 8, 2004, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1- AU-05); and U.S. Patent Application No. 10/571,012, filed on March 8, 2006, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1- US-06) to Arana Therapeutics (VIC) Pty. Ltd., having a place of business at Level 5, Building 4, 399 Royal Parade, Parkville, Victoria 3052, Australia, a wholly-owned subsidiary of Arana Therapeutics Limited, having a place of business at Level 2, 37 Epping Road, Macquarie Park, NSW 2113, Australia, a wholly-owned subsidiary of Cephalon, Inc., having a place of business at 41 Moores Road, Frazer, PA 19355, USA. The patent rights in this invention have been assigned to the United States of America.

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, October 21, 2009. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the use of catheter ablation for the treatment of atrial fibrillation. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of HRSA programs, including the Health Center Program. Therefore, we are requesting comments on the PIN referenced above. Comments will be reviewed and analyzed, and a summary and general response will be published as soon as possible after the deadline for receipt of comments.

This notice announces our decision to approve the American Osteopathic Association (AOA) for continued recognition as a national accreditation program for hospitals seeking to participate in the Medicare or Medicaid programs.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Air Force Research Laboratory. This Memorandum of Understanding (MOU) between the Food and Drug Administration, National Center for Toxicological Research (NCTR), and the Air Force Research Laboratory, 711 Human Performance Wing, Human Effectiveness Directorate, Biosciences and Protection Division, Applied Biotechnology Branch (711 HPW/RHPB) (hereinafter referred to as ``the Parties''), sets forth the agreement of the Parties to facilitate information sharing in the area of toxicogenomic and computational toxicology research. Through the exchange of information, the Parties intend to coordinate research efforts so as to identify and expedite research and development of new tools and technologies that can be implemented that promote new understanding of the mechanisms of biological responses to environmental stressors, including toxic injury, and to identify biomarkers of exposure and disease that can be used to improve and protect human health.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems, and to implement certain provisions made by the TMA, Abstinence Education, and QI Program Extension Act of 2007, the Medicare Improvements for Patients and Providers Act of 2008, and the American Recovery and Reinvestment Act of 2009. In addition, in the Addendum to this final rule, we describe the changes to the amounts and factors used to determine the rates for Medicare acute care hospital inpatient services for operating costs and capital-related costs. These changes are applicable to discharges occurring on or after October 1, 2009. We also are setting forth the update to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. The updated rate-of- increase limits are effective for cost reporting periods beginning on or after October 1, 2009.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should e-mail nvpo@hhs.gov, call 202-690-5566, or complete the on-line form on the NVAC Web site (https:// www.hhs.gov/nvpo/nvac/.) to register.

The Office of Public Health and Science, Office on Women's Health, HHS, is seeking nominations of qualified candidates to be considered for appointment as a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides science-based advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on a broad range of issues and topics pertaining to chronic fatigue syndrome (CFS). CFSAC, which was formerly known as the Chronic Fatigue Syndrome Coordinating Committee, was established by the Secretary of Health and Human Services on September 5, 2002. The appointments of five Committee members are scheduled to end on January 3, 2010. Nominations of qualified candidates are being sought to fill these scheduled vacancies.

The Health Resources and Services Administration (HRSA) is issuing non-competitive supplemental funding under the Office of Health Information Technology, Office for the Advancement of Telehealth, Telehealth Resource Center Grant Program to ensure that the Center for Telehealth & E-Health Law, the National Telehealth Resource Center (NTRC) in Washington, DC, can continue to provide much needed technical assistance services to the Regional Telehealth Resource Centers (RTRCs), HRSA grantees and new and existing telehealth organizations in

The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee (the committee) in the Office of Science, Center for Tobacco Products. Elsewhere in this issue of the Federal Register, FDA is publishing a document announcing the establishment of this committee.

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on its Tobacco Products Scientific Advisory Committee 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. Elsewhere in this issue of the Federal Register, FDA is publishing two separate documents announcing the establishment of the committee and the request for nomination of the Tobacco Products Scientific Advisory Committee.

The Food and Drug Administration (FDA) Philadelphia District, in cosponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop entitled: ``FDA Clinical Trial Requirements, Regulations, Compliance and GCP.'' This 2-day public workshop is intended to provide information about FDA clinical trial requirements to the regulated industry.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director (OD), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June 16, 2009 (Volume 74, Number 114, pages 28501-28502) and allowed 60 days for public comment. No 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.

The Department of Health and Human Services is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which amends the Patient Safety and Quality Improvement Rule by adjusting for inflation the maximum civil money penalty amount for violations of the confidentiality provisions of the Rule. We are proposing to amend the penalty amount to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990.

The Food and Drug Administration (FDA) is implementing a direct final rule correcting the regulation classifying herpes simplex virus (HSV) serological assays by removing the reference to HSV serological assays other than type 1 and type 2. When reclassifying this device, FDA mistakenly distinguished between HSV serological assays type 1 and type 2 and all other HSV serological assays. At that time, and today, the only preamendments HSV serological assays which FDA was aware of were type 1 and type 2 and, therefore, the classification of HSV assays other than type 1 and type 2 was incorrect. FDA is correcting the classification of this device to eliminate possible confusion resulting from this error. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedure for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this direct final rule.

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 information collection provisions of the Mental Models Study of Recruitment and Retention of Pregnant Women into an Asthma Pregnancy Registry. Pregnancy registries are a common source of safety information about medications used during pregnancy. Together with other information being collected, FDA will use the results from this study to better understand how pregnant women and their health care providers make decisions about participation in pregnancy exposure registries. FDA will use this new knowledge to develop and recommend effective ways to support the involvement of health care providers and pregnant women in pregnancy registries. Ultimately, greater involvement of health care providers and pregnant women in pregnancy registries will improve the quality of safety information gathered through the registries. Better safety information will support informed treatment decisions by health care providers and women who need prescription medications while pregnant.

The Food and Drug Administration (FDA) has determined the regulatory review period for LEXISCAN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.

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 Internet Survey on Barriers to Food Label Use.

This is a time-sensitive Request for Information (RFI) issued by the Emergency Care Coordination Center in the Office of the Assistant Secretary for Preparedness and Response on behalf of the Council on Emergency Medical Care (CEMC) and the Federal Interagency Committee on Emergency Medical Services (FICEMS)collectively known as the Emergency Care Enterprise (ECE). The information requested is meant to ascertain key concepts, best practices, and operational approaches to support regionalized, comprehensive and accountable emergency care and trauma systems. The information will be analyzed by the ECCC to help guide the development of demonstration programs that design and evaluate innovative models of regionalized, coordinated and accountable emergency care and trauma systems.

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of August 3, 2009 (74 FR 38438). The document announced the availability of a draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes.'' The document was published with an incorrect date for submitting written or electronic comments on the draft guidance. This document corrects that error.

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of August 3, 2009 (74 FR 38439). The document announced the availability of a draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens.'' The document was published with an incorrect date for submitting written or electronic comments on the draft guidance. This document corrects that error.

In the last decade, the Food and Drug Adminstration (FDA) has achieved great success in reforming and modernizing its regulatory processes and responsibilities as a result of changes and improvements driven by the requirements of the Prescription Drug User Fee Act (PDUFA), the 1997 FDA Modernization Act (FDAMA), and other legislation. PDUFA was reauthorized by the Food and Drug Administration Amendments Act of 2007, Title I, Prescription Drug User Fee Amendments of 2007 (PDUFA IV). FDA plans to make even greater progress during the PDUFA IV timeframe (Fiscal Years 2008 through 2012), building on the foundation established in previous years. The additional resources provided by user fees, when combined with appropriations, have enabled the FDA to modernize its information technology infrastructure and begin a monumental transformation from a paper-based to an electronic work environment.

The Food and Drug Administration (FDA) is proposing to amend its postmarket medical device reporting regulation to require that manufacturers, importers, and user facilities submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs) to the agency in an electronic format that FDA can process, review, and archive. Mandatory electronic reporting would improve the agency's process for collecting and analyzing postmarket medical device adverse event information. The proposed regulatory changes would provide the agency with a more efficient data entry process that would allow for timely access to medical device adverse event information and identification of emerging public health issues. Elsewhere in this issue of the Federal Register, FDA is also announcing a draft guidance document that provides recommendations on how to prepare and submit electronic MDRs to FDA in a manner that satisfies the requirements of this proposed regulation. The proposal also includes modifications to the regulations specifying the content of required MDRs to better track information already solicited on the FDA Form 3500A.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``eMDRElectronic Medical

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``2010-2011 Medical Expenditure Panel Survey Insurance Component.'' In accordance with the Paperwork Reduction Act of 1995, 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 announcing that a collection of information entitled ``MedWatch: Food and Drug Administration Medical Products Reporting Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

We are proposing to add Chapare virus to the list of HHS select agents and toxins. We are proposing this action because Chapare virus has been phylogenetically identified as a Clade B arenavirus and is closely related to other currently regulated South American arenaviruses that cause haemorrhagic fever, particularly Sabia virus.

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:

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Mental Models Study of Farmers' Understanding and Implementation of Good Agricultural Practices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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.

The Food and Drug Administration is correcting a notice entitled that appeared in the Federal Register of August 3, 2009 (74 FR 38429). The document announced the Fiscal Year 2010 fee rates for the Animal Drug User Fee Act. The document was published with a typographical error. This document corrects that error.

The Food and Drug Administration (FDA) has reorganized the Office of the Commissioner (OC). This reorganization includes the organizations and their substructure components as listed in this document. This reorganization includes the re-alignment of four Deputy- level offices within the Office of the Commissioner: the Office of the Chief Scientist; the Office of Administration (formerly titled the Office of Operations); the Office of Foods; and the Office of Policy, Planning and Budget (formerly titled the Office of Policy, Planning and Preparedness).

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 its determination that DEMADEX (torsemide) injection, 20 milligrams (mg)/2 milliliter (mL) (10 mg/mL) and 50 mg/5 mL (10 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 torsemide injection, 20 mg/2mL (10 mg/mL) and 50 mg/5 mL (10 mg/mL), if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 9: Tablet Friability General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Tablet Friability General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This draft guidance is the ninth annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).

On January 21, 2009, CDC published a notice in the Federal Register (74 FR 3608) announcing its intent to rescind its February 4, 2004 order and subsequent amendments prohibiting the importation of birds and bird products from specified countries based on the threat that imports from such countries increases the risk that highly pathogenic avian influenza (HPAI) may be introduced into the United States. The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) has implemented and continues to enforce regulations to prohibit or restrict the importation of birds, poultry, and unprocessed birds and poultry products from regions that have reported the presence of highly pathogenic avian influenza H5N1 in poultry. While USDA/APHIS actions are based primarily on protecting the U.S. commercial poultry industry from the introduction of highly pathogenic avian influenza H5N1, these actions have the added benefit of mitigating the risk of human exposure to the virus. Because the

The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulation concerning charging patients for investigational new drugs. This final rule revises the charging regulation to clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, to set forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in the agency's final rule on expanded access for treatment use of investigational drugs published elsewhere in this issue of the Federal Register, and to clarify what costs can be recovered for an investigational drug. This final rule will permit charging for a broader range of uses than was explicitly permitted previously.

In compliance with the requirement of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collected below. This proposed information collection was previously published in the Federal Register on June 10, 2009 (74 FR 27552), and allowed 60 days for public comment. One public comment was received regarding pharmaceutical testing. The submitter responded to the e-mail. 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 valid OMB control number.