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

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated February 2007. The guidance document assists establishments with making eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products. The guidance announced in this document finalizes the draft guidance, ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated May 2004. This guidance also finalizes the draft guidance, ``Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt- Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps),'' dated June 2002 (Docket No. 2002D-0266).

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Advisory Committee MeetingsPreparation and Public Availability of Information Given to Advisory Committee Members.'' This guidance is intended to provide information to industry sponsors, applicants, and petitioners on the development, preparation, or submission of briefing materials that will be given to advisory committee members as background information prior to open FDA advisory committee meetings. The guidance will help sponsors develop, organize, and submit advisory committee briefing materials for public release and should help minimize the time and resources spent in preparing these materials for public availability. The guidance also describes the process FDA intends to follow when we make briefing materials available to the public.

Notice is hereby given that an award is being made to the National Eligibility Workers Association: Professionals Associated Through Human Services of Cavalier, North Dakota, in the amount of $100,000 to develop a best practices handbook for front line social workers. NEW:PATHS is the only national organization dedicated to improving the personal and professional well-being of eligibility professionals and they are uniquely qualified to develop a handbook of best practices. Its members implement Temporary Assistance to Needy Families regulations, network with other eligibility professionals at local, regional, and national conferences and possess exceptional insights concerning Federal programs. NEW:PATHS has the capability of consulting with a national audience and its members are in direct contact with employment agencies to move participants from welfare to work and increase the percentage of families and children living in safe environments. After the appropriate reviews, it has been determined that this unsolicited proposal qualifies for funding. The period of this funding will extend from October 1, 2006 through March 31, 2008. Contact: Paul Maiers, Office of Family Assistance, Administration for Children and Families, 370 L'Enfant Promenade, SW., Washington, DC 20447, Telephone: 202-401-5438, E-mail: paul.maiers@acf.hhs.gov.

In accordance with the Privacy Act, we are proposing to modify or alter an existing SOR, ``Program Information Management System (PIMS),'' System No. 09-90-0052, published at 67 FR 57011, September 6, 2002. First, we propose to add a new authority, the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), to those under which OCR collects information. The Secretary of HHS has delegated to OCR the authority to enforce the confidentiality provisions of that statute. Second, we propose a new routine use which allows referrals of Age Discrimination Act Complaints to the Federal Mediation and Conciliation Service (FMCS), for purposes of mediation. Third, we give notice of a new routine use permitting disclosure of records to student volunteers, individuals working under a personal services contract, and other individuals performing functions for the Department but technically not having the status of OCR employees, if they need access to the records in order to perform their assigned agency functions. OCR invites interested parties to submit comments on the proposed additional authority and routine uses. See Effective Dates section for comment period.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.'' In recent years, the practice of complementary and alternative medicine (CAM) has increased in the United States, and we have seen increased confusion as to whether certain products used in CAM are subject to regulation under the Federal Food, Drug, and Cosmetic Act (the act) or Public Health Service Act (PHS Act). We have also seen an increase in the number of CAM products imported into the United States. Therefore, the draft guidance discusses when a CAM product is subject to the act or the PHS Act.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions in FDA's food labeling regulations.

The Food and Drug Administration (FDA) is publishing a proposed rule to reclassify pressure regulators for use with medical oxygen, currently class I devices included in the generic type of device called pressure regulator, into class II, subject to special controls in the form of a guidance document. Pressure regulators for use with all other medical gases will remain in class I, subject only to general controls. FDA is also proposing to establish a separate classification regulation for oxygen conserving devices (or oxygen conservers), now included in the generic type of device called noncontinuous ventilator. Oxygen conserving devices will continue to be classified in class II, but those that incorporate a built-in oxygen pressure regulator will become subject to the special controls guidance if the rule is finalized. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls draft guidance for industry and FDA staff entitled ``Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices.'' The agency is proposing this action because it believes that special controls are necessary to provide a reasonable assurance of safety and effectiveness for these devices.

The Health Resources and Services Administration published a notice in the Federal Register of December 6, 2006, soliciting comments on a proposed amendment to Policy Notice 99-02 which places a cumulative lifetime period of 24 months on short-term and emergency housing assistance under Title XXVI of the Public Health Service Act, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006. The amendment also specifies a requirement that the need for such assistance must be certified or documented by a case manager, social worker, or other licensed health care professional(s). HRSA received over 150 substantive comments from consumers and numerous organizations around the country in response to the December 6, 2006, notice.

NIGMS is initiating a strategic planning process that will culminate in the NIGMS Strategic Plan for 2008-2012. To assist with this process, NIGMS requests input from scientists, scientific organizations, and other interested parties. The goal of this strategic planning process is to identify Institute priorities and guide decision-making over the next five years. Information about NIGMS can be found at https://www.nigms.nih.gov/.

The Food and Drug Administration (FDA) has determined the regulatory review period for S8 OVER-THE-WIRE SYSTEM 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 a patent which claims that medical device.

This notice announces a hospital's request for a waiver from entering into an agreement with its designated organ procurement organization (OPO), in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.

The Food and Drug Administration (FDA) has determined the regulatory review period for BARACLUDE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.

This notice announces five new members selected to serve on the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary, DHHS, (the Secretary) and the Administrator, CMS, (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the annual updates of the hospital outpatient prospective payment system (OPPS).

This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2007 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. Discussion will be directed toward responses to our specific preliminary recommendations and will include all items on the public meeting agenda.

This notice announces CMS' grant of deeming authority to the Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that the requirements of the Joint Commission accreditation process are equal to or more stringent than the CLIA condition level requirements, and that the Joint Commission has met the requirements of subpart E of 42 CFR part 493. Consequently, laboratories that are voluntarily accredited by the Joint Commission and continue to meet the Joint Commission requirements will be deemed to meet the CLIA condition level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to Federal validation and complaint investigation surveys conducted by us or our designee.

This notice announces the 15th meeting of the American Health Information Community Population Care and Clinical Care Connections Workgroup [formerly BioSurveillance Workgroup] in accordance with the Federal Advisory Committee Act (Pub. L. no. 92-463, 5 U.S.C., App.)

This notice announces the 14th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the 3rd meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 93-463, 5 U.S.C., App.).

The Food and Drug Administration (FDA) is announcing the effective date for the information collection requirements contained in a final rule published in the Federal Register of August 25, 2000 (65 FR 51758). The rule amended FDA's regulations on food additive and color additive petitions to permit an efficient joint review by both FDA and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA), of petitions for approval to use a food ingredient or source of radiation in or on meat or poultry products. An information collection requirement cannot be instituted unless it is reviewed by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA), approved by OMB, and assigned an OMB control number. OMB's approval of the information collection requirements of the August 25, 2000, final rule was announced in the Federal Register of March 1, 2001 (66 FR 12938), and these requirements are currently approved under OMB control number 0910-0016. Accordingly, FDA is announcing that the information collection requirements of the August 25, 2000, final rule will go into effect on March 26, 2007.

The Privacy Act of 1974 and section 1106 of the Social Security Act (the Act) explain when and how CMS may release the personal data of people with Medicare. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law 108-173) added requirements for releasing and using personal data. The primary purpose of this system is to collect, maintain, and process information on all Medicare covered, and as many non-covered drug events as possible, for people with Medicare who have a Medicare Part D plan. The system will help CMS determine appropriate payment of covered drugs. It will also provide for processing, storing, and maintaining drug transaction data in a large-scale database, while putting data into data marts to support payment analysis. CMS would allow the release of information in this system to: (1) Support regulatory, analysis, oversight, reimbursement, and policy functions performed within the agency or by a contractor, consultant, or a CMS grantee; (2) help another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) help Medicare Part D plans; (4) support an individual or organization for a research, an evaluation, or an epidemiological or other project related to protecting the public's health, the prevention of disease or disability, the restoration or maintenance of health, or for payment related purposes; (5) help Quality Improvement Organizations; (6) support lawsuits involving the agency; and (7) combat fraud, waste, and abuse in certain health benefits programs. To meet these additional requirements, CMS proposes to modify the existing system of records (SOR) titled ``Medicare Drug Data Processing System (DDPS),'' System No. 09-70-0553, established at 70 Federal Register (FR) 58436 (October 6, 2005). Under this modification we are clarifying the statutory authorities for which these data are collected and disclosed. The original SOR notice cited the statutory section governing CMS's payment of Part D plan sponsors (Social Security Act (the Act) Sec. 1860D-15) that limits the uses of the data collected to plan payment and oversight of plan payment. However, the broad authority of Sec. 1860D-12(b)(3)(D) authorizes CMS to collect, use and disclose these same claims data for broader purposes related to CMS's responsibilities for program administration and research. Furthermore the authority under Sec. 1106 of the Act allows the Secretary to release data pursuant to a regulation, which in this case would be 42 CFR 423.322 and 423.505. CMS has published a Notice of Proposed Rulemaking (NPRM) in order to clarify our statutory authority and explain how we propose to implement the broad authority of Sec. 1860D- 12(b)(3)(D). This SOR is being revised to reflect our intended use of this broader statutory authority. CMS proposes to make the following modifications to the DDPS system: Revise routine use number 1 to include CMS grantees that perform a task for the agency. Add a new routine use number 2 to allow the release of information to other Federal and state agencies for accurate payment of Medicare benefits; to administer a Federal health benefits program, or to fulfill a requirement or allowance of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and help Federal/state Medicaid programs that may need information from this system. Broaden the scope of routine use number 4 to allow the release of data to an individual or organization for a research, evaluation, or epidemiological or other project related to protecting the public's health, the prevention of disease or disability, the restoration or maintenance of health, or payment-related projects. Delete routine use number 5 which authorizes disclosure to support constituent requests made to a congressional representative. Broaden the scope of routine use number 7 and 8, to include combating ``waste,'' fraud, and abuse that results in unnecessary cost to all Federally-funded health benefit programs. Revise language regarding routine uses disclosures to explain the purpose of the routine use and make clear CMS's intention to release personal information contained in this system. Reorder and prioritize the routine uses. Update any sections of the system affected by the reorganization or revision of routine uses because of MMA provisions. Update language in the administrative sections to be consistent with language used in other CMS SORs. Although the Privacy Act allows CMS to only ask for comments on the modified routine uses, CMS is asking for comments on all proposed changes discussed in this notice. See the EFFECTIVE DATES section below for the comment period.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collection of information, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. We are publishing a revised version of the notice that we published in the Federal Register on January 30, 2006 (72 FR 4273-4274) to reflect a correction in the data presented in Table A. In the previous notice, we inadvertently calculated the burden totals on the basis of 400 subjects for a single year. We should have calculated the burden totals on the basis of 400 subjects per each of three study years. Today's notice corrects that error.

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

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 Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for use of an additional dose of trenbolone acetate and estradiol implant used for increased rate of weight gain and improved feed efficiency in feedlot steers.

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 (FDA) is correcting a notice that appeared in the Federal Register of February 2, 2007 (72 FR 5057). The document announced that an opportunity for public comment on a proposed collection of information had been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. The notice published with an error in titles referring to an FDA form number in two places in the document. This document corrects those errors.

This notice announces the 12th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).

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 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 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 license to practice the invention embodied in: (1) U.S. Patent No. 5,821,081, filed April 26, 1996, issued Oct. 13, 1998, entitled ``Nucleic Acids Encoding Antiviral Proteins and Peptides, Vectors and Host Cells Comprising Same, and Methods of Producing the Antiviral Proteins and Peptides'' (E-117-1995/1-US-01) (Inventors: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker, and James B. McMahon) (NCI); (2) U.S. Patent No. 5,843,882, filed April 27, 1995, issued Dec. 01, 1998, entitled ``Antiviral Proteins and Peptides, DNA, DNA-coding Sequences Therefore, and Uses thereof `` (E-117-1995/0-US-01) (Inventors: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker, and James B. McMahon) (NCI); (3) U.S. Patent No. 5,998,587, filed Nov. 13, 1997, issued Dec. 7, 1999, entitled ``Anti-cyanovirin Antibody'' (E-117-1995/1-US-02) (Inventors: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker, and James B. McMahon) (NCI); (4) U.S. Patent No. 6,015,876, filed Oct. 27, 1999, issued Jan. 18, 2000, entitled ``Method of Using Cyanovirins'' (E-117-1995/0-US-02) (Inventor: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker, and James B. McMahon) (NCI); (5) U.S. Patent No. 6,780,847, filed March 22, 2001, issued August 24, 2004, entitled ``Glycosylation-Resistant Cyanovirins and Related Conjugates, Compositions, Nucleic Acids, Vectors, Host Cells, Methods of Production and Methods of Using Nonglycosylated Cyanovirins'' (E- 074-1999/3-US-01) (Inventors: Michael R. Boyd, Barry O'Keefe, Toshiyuki Mori (NCI) and Angela Gronenborn (NIDDK)); (6) U.S. Patent No. 7,048,935, filed July 1, 2002, issued May 23, 2006, entitled ``Cyanovirin Conjugates and Matrix-Anchored Cyanovirin and Related Compositions and Methods of Use'' (E-074-1999/1-US-03) (Inventor: Michael R. Boyd (NCI); (7) U.S. Patent No. 7,105,169, filed September 12, 2001, issued September 12, 2006, entitled ``Cyanovirins Conjugates and Matrix- Anchored Cyanovirins and Methods of Use'' (E-074-1999/1-US-02) (Inventor: Michael R. Boyd (NCI); (8) U.S. Patent No. 6,743,577, filed October 27, 1999, issued June 1, 2004, entitled `` Methods of Using Cyanovirins to Inhibit Viral Infection'' (E-074-1999/0-US-03) (Inventor: Michael R. Boyd (NCI);

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Labeling; Notification Procedures for Statements on Dietary Supplements'' 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 collection of information entitled ``User Fee Cover Sheet; Form FDA 3397'' 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 Health Resources and Services Administration (HRSA) is requesting nominations to fill eight (8) vacancies on the Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children.

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 proposed information collection project: ``Pilot Study of Proposed Nursing Home Survey on Resident Safety.'' 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. This proposed information collection was previously published in the Federal Register on December 12th, 2006 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 Food and Drug Administration (FDA) is announcing the availability of a draft compliance policy guide (CPG) entitled ``Voluntary Self Inspection of Medicated Feed Manufacturing Facilities.'' This draft CPG is intended to provide guidance to the FDA field offices in prioritizing inspections of medicated feed manufacturing facilities for compliance with Current Good Manufacturing Practices for Medicated Feeds regulations (CGMP).

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 the Y-12 Plant in Oak Ridge, Tennessee, 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: Y-12 Plant. Location: Oak Ridge, Tennessee. Job Titles and/or Job Duties: All statisticians in all locations. Period of Employment: January 1, 1951 through June 30, 1959.

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 proposed information collection project: ``Pilot Study of Proposed Medical Office Surveys on Patient Safety.'' 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. This proposed information collection was previously published in the Federal Register on December 6, 2006 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 Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR.'' This guidance describes the circumstances under which user fees will not be assessed for certain applications for fixed dose combination (FDC) and co-packaged versions of previously approved antiretroviral therapies for the treatment of human immunodeficiency virus (HIV) under the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief (PEPFAR). The guidance also describes some circumstances under which most of the applications that will be assessed fees may be eligible for a public health or a barrier-to-innovation waiver.

The HHS Office of Inspector General Published a document in the Federal Register of October 18, 2006, imposed exclusions. The document contained the incorrect monthly exclusions.

This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Centers for Disease Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a limited field of use, exclusive license in China, and a co-exclusive worldwide (excluding China) license to practice the invention embodied in the patent application referred to below to Ringpu (Baoding) Biologics and Pharmaceuticals Co. LTD., having a place of business in Baoding City, Hebel Province, PR China. CDC intends to grant rights to practice this invention (in territories other than China) to no more than two other co-licensees. The patent rights in these inventions have been assigned to the government of the United States of America. The patent application to be licensed is: