Department of Health and Human Services July 13, 2005 – Federal Register Recent Federal Regulation Documents
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Prospective Grant of Exclusive License: Mesothelin, a Differentiation Antigen Present on Mesothelium, Mesotheliomas and Ovarian Cancers and Methods and Kits for Targeting
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, 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. 60/010,166, filed January 5, 1996, entitled ``Mesothelin, A Differentiation Antigen Present On Mesothelium, Mesotheliomas And Ovarian Cancers And Methods And Kits For Targeting'' [E-002-1996/0-US-01]; United States Patent No. 6,153,430, issued on November 28, 2000, entitled ``Nucleic Acid Encoding Mesothelin, A Differentiation Antigen Present On Mesothelium, Mesotheliomas And Ovarian Cancers'' [E-002-1996/0-US-02]; United States Patent Application No. 09/684,599, filed October 5, 2000, entitled ``Mesothelin, A Differentiation Antigen Present On Mesothelium, Mesotheliomas And Ovarian Cancers And Methods And Kits For Targeting'' (E-002-1996/0-US-03); United States Patent No. 6,083,502, issued on July 4, 2000, entitled ``Mesothelium Antigen And Methods And Kits For Targeting It'' [E-002-1996/1-US-02]; PCT Application No. PCT/US97/ 00224, filed January 3, 1997, entitled ``Mesothelium Antigen And Methods And Kits For Targeting It'' [E-002-1996/1-PCT-01]; Australian Patent No. 703769, filed January 3, 1997, entitled ``Mesothelium Antigen And Methods And Kits For Targeting It'' [E-002-1996/1-AU-03]; Canadian Patent No. 2241604, filed January 3, 1997, entitled ``Mesothelium Antigen And Methods And Kits For Targeting It'' [E-002- 1996/1-CA-04]; Japanese Patent Application No. 9-525355, filed January 3, 1997, entitled ``Mesothelium Antigen And Methods And Kits For Targeting It'' [E-002-1996/1-JP-06]; European Patent No. 0871492, filed January 3, 1997, entitled ``Mesothelium Antigen And Methods And Kits For Targeting It'' [E-002-1996/1-EP-05]; Switzerland Patent Application No. 0871492, filed January 3, 1997, entitled ``Mesothelium Antigen And Methods And Kits For Targeting It'' [E-002-1996/1-CH-07]; German Patent No. 69726404.1, filed January 3, 1997, entitled ``Mesothelium Antigen And Methods And Kits For Targeting It'' (E-002-1996/1-DE-08); French Patent Application No. 0871492, filed January 3, 1997, entitled ``Mesothelium Antigen And Methods And Kits For Targeting It'' [E-002- 1996/1-FR-09]; Italian Patent No. 05503/BE/2004, January 3, 1997, entitled ``Mesothelium Antigen And Methods And Kits For Targeting It'' [E-002-1996/1T-10]; Spanish Patent No. 0871492, filed January 3, 1997, entitled ``Mesothelium Antigen And Methods And Kits For Targeting It'' [E-002-1996/1-ES-11]; United Kingdom Patent No. 0871492, filed January 3, 1997, entitled ``Mesothelium Antigen And Methods And Kits For Targeting It'' [E-002-1996/1-GB-12]; United States Patent No. 5,320,956, issued June 14, 1996, entitled ``Monoclonal Antibody'' [E-195-1990/0-US-20]; United States Patent No. 5,525,337, issued June 11, 1996, entitled ``Monoclonal Antibody Binding Cell Surface Antigen For Diagnosing Cancer'' [E-195-1990/0-US-21]; United States Patent No. 5,817,313, issued October 6, 1998, entitled ``Monoclonal Antibodies And Conjugates Thereof Useful For The Treatment Of Cancer'' [E-195-1990/0-US-22]; PCT Patent Application No. PCT/US91/ 07227, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195- 1990/0-PCT-02]; Denmark Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-DK-03]; United Kingdom Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-GB-04]; Austrian Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-AT-05]; Belgium Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-BE-06]; European Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E- 195-1990/0-EP-09]; French Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-FR-11]; German Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-DE-08]; Greece Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-GR-12]; Netherlands Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-NL-15]; Italian Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-IT-13]; Luxembourg Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-LU-14]; Spanish Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E- 195-1990/0-ES-10]; Sweden Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-SE-16]; Switzerland Patent No. 0554356, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-CH-07]; Australian Patent No. 648363, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-AU-17]; Canadian Patent No. 2093928, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E-195-1990/0-CA-18]; and Japanese Patent No. 2660241, filed October 9, 1991, entitled ``Monoclonal Antibody'' [E- 195-1990/0-JP-19] to Morphotek, Inc., which has offices in Exton, Pennsylvania. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of licensee's MORAb-009 antibody for the treatment of mesothelin-expressing cancer.
Notice of Correction to Availability of Funds for the Projects To Establish Public Assistance Reporting Information System (PARIS) State Partnership Grants
This notice is to inform interested parties of changes made to the Funding Opportunity for Projects to Establish Public Assistance Reporting Information System (PARIS) State Partnership Grants published on Monday, April 25, 2005, with a due date for applications of June 24, 2005, which is now extended until August 8, 2005. 1. The following changes are made to Section I, ``Funding Opportunity Description'': a. There will be separate grants awarded to each Member and Partner State, such that a Member State will no longer have fiduciary responsibility for its Partner State [page 21222]; b. The following paragraph is struck: ``After evaluation of all grant applications, and if chosen for an award, the Member state will be awarded a grant under which it will act as a fiduciary agent to the Partner state. The Member state will be responsible for all funding that is provided to its Partner state and will reimburse funding provided hereunder, as costs are incurred, for specific items delineated in its approved grant application budget and in accordance with HHS fiscal and grants management requirements.'' [page 21222] and replaced with: ``Separate applications for a partnership agreement must be submitted by both the Member State and the Partner State with separate budget requests. An application from a Partner State must identify its Member State and an application from a Member State must identify its Partner State. As costs are incurred for specific items delineated in the approved grant application budgets, States must adhere to HHS fiscal and grants management requirements.''; c. The phrase ``Member State'' is struck and replaced with ``State'' in the paragraph that reads: ``This list is meant to be illustrative, not exhaustive of the type of issues the Member state should address when preparing the application.'' [page 21222]; 2. The following changes are made to Section I, ``Funding Opportunity Description,'' under the ``parameters'' list [page 21222]: a. In the first sentence in paragraph (3), the phrase ``the Member State'' is replaced with ``each applicant'' so that the sentence reads, ``Each applicant must provide a proposed budget that includes the resources and associated costs it believes are necessary to participate in the match process.'' The second sentence is revised to read: ``The proposed budgets will be evaluated for adequacy, reasonableness, and to ensure that implementation of the partnership will be both operationally effective and successful''; b. The language in paragraph (5) is struck and replaced with: ``For Member States to be eligible for this funding opportunity they must have participated in at least two of the last six PARIS matches from (February 2004 through May 2005)''; c. The language in paragraph (6) is struck and replaced with: ``Applicants are cautioned that the ceiling for each grant award is $200,000 for a Partner State and $100,000 for a Member State. Applications exceeding the $200,000/$100,000 threshold will be considered non-responsive and will not be eligible for funding under this announcement''; d. The first sentence in paragraph (7) is struck and replaced with: ``Two applications must be submitted for each identified partnership One from a Member State and one from a Partner State.''; e. The language in paragraph (8) is struck and replaced with: ``The Partner State must enroll in the PARIS Project and provide a copy of the PARIS agreement to ACF prior to the grant award issuance in order to document the Partner State's consent to the project. The following link shows the PARIS Agreement: https://www.acf.hhs.gov/nhsitrc/paris/ agreepar.html ''; f. The language in paragraph (10) is struck and replaced with: ``Besides the Interstate and Veterans matches, States are encouraged to participate in any additional matches available, such as the Federal match.''; 3. The following changes are made to Section II, ``Award Information'': The ``Ceiling on the Amount of Individual Awards Per Project Period'' and the ``Average Projected Award Amount Per Project Period'' are revised as follows: ``$200,000 for a Partner State and $100,000 for a Member State'' [page 21223]; 4. The following changes are made to Section III.1, ``Eligibility Information, Additional Information on Eligibility'' [page 21223]: a. The first sentence is struck and replaced with, ``In the context of this grant announcement, eligible applicants include both Member States of PARIS and proposed Partner States as defined in Section I, ``Funding Opportunity Description.'' To be considered an eligible Member State, the State must have participated in at least two of the last six quarterly matches from February 2004 through May 2005.''; b. The sentence reading: ``The following States meet this eligibility factor'' now includes Oregon in the list of eligible Member States; c. The sentence that reads ``* * * and only these Member States may submit applications under this grant'' is struck and replaced with ``only these eligible Member States may qualify to submit applications under this grant announcement as Member States defined in this grant announcement.''; d. The sentence reading, ``The application must include the Partnership agreement as well as the appropriate signed PARIS agreement for the Partner State,'' is struck and replaced with: ``The application need only identify the other State in the Partnership in lieu of attaching the actual agreement; however, a signed PARIS agreement and Partnership agreement must both be provided to ACF prior to the grant award issuance.'' 5. The following changes are made to Section III (3), ``Eligibility Information, Other, Disqualification Factors'' [page 21223]: a. The sentence stating, ``Applications that are not submitted by a Member state,'' is struck and replaced with: ``Applications that are not submitted by a State.'' ; b. The following sentence is struck: ``Applications that fail to include a written Partnership agreement between the Member state and Partner state.''; c. The following sentence is struck: ``Applications that fail to provide a signed PARIS agreement by the Partner state.''; d. In the sentence that reads, ``Applications that fail to specify at least two of the last six quarterly PARIS matches from November 2003 through February 2005 in which the Member state has participated,'' the dates are struck and replaced with ``February 2004'' and ``May 2005'' respectively. 6. The following changes are made to IV.2, ``Application and Submission Information, Content and Form of Application Submission'': a. The sentence, ``Applications must contain a partnership agreement from the Partner State indicating its agreement to team with the Member State for purposes of this grant'' is struck and replaced with: ``Applications should identify what other State, be they a Member State or a Partner State, they are teaming with. The teaming or partnership agreement must be submitted to ACF prior to grant award issuance.'' [page 21223]; b. The sentence, ``Note that the application requires proof of an agreement between the PARIS Member State and its Partner State as well as a signed PARIS agreement (available on the PARIS website)'' is struck and replaced with: ``The proof of agreement between the PARIS Member State and its Partner State, as well as a signed PARIS agreement (available on the PARIS website), must both be submitted to ACF prior to grant award issuance.'' [page 21224]; 7. The following changes are made to Section IV. 3, ``Submission Dates and Times, Due Date for Applications'': The due date for applications is extended from June 24, 2005 to August 8, 2005. [page 21224]; 8. The following changes are made to Section IV.3, the ``Checklist'': Under the ``When to Submit'' column, the language for the PARIS Agreement and Partnership Agreement is replaced with, ``By date of award.'' [page 21225]; 9. The following changes are made to Section V, ``Application Review Information, Evaluation Criteria'' [page 21228]: a. The paragraph under the criterion ``Approach'' is struck and replaced with: ``Applications will be evaluated in terms of the extent to which they include a plan that (1) reflects the understanding of the characteristics, needs and services that are available from the PARIS Project and the potential for a Partnership agreement achieving the provision of services that directly address the fulfillment of the PARIS Project; (2) is appropriate and feasible; (3) can be reliably evaluated; (4) if successfully implemented, can be sustained after Federal funding has ceased.''; b. The point value for the criterion ``Budget and Budget Justification'' is revised from 10 points to 15 points; c. The entire criterion ``Third-Party Agreements'' worth 5 points is struck. 10. The second full paragraph in Section V(2), ``Review and Selection Process'' is revised to read: ``If an insufficient number of acceptable applications, as determined by ACF, are received under this program announcement ACF has the option of negotiating and awarding grant amounts higher than the $200,000 award ceiling for Partner States and $100,000 award ceiling for Member States, set forth in this announcement among those applicants who have submitted acceptable applications.''
Memorandum of Understanding Between the Food and Drug Administration and the Food and Drug Administration Alumni Association, Inc.
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration and the Food and Drug Administration Alumni Association, Inc., (FDAAA). FDA and FDAAA agree to partner on future specific undertakings that are considered beneficial to both organizations, are directly related to the mission of FDA, and are within FDA's statutory authorities.
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of Monograph for Over-the-Counter Bronchodilator Drug Products
The Food and Drug Administration (FDA) is proposing to amend the final monograph (FM) for over-the-counter (OTC) bronchodilator drug products to add additional warnings (e.g., an ``Asthma alert'') and to revise the indications, warnings, and directions in the labeling of products containing the ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine hydrochloride, and racepinephrine hydrochloride. This proposed rule is part of FDA's ongoing review of OTC drug products. FDA is also withdrawing the proposed rule (see the Federal Register of July 27, 1995 (60 FR 38643)) to remove the ephedrine ingredients from the FM.
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph for Combination Drug Products
The Food and Drug Administration (FDA) is proposing to amend the tentative final monograph (TFM) for over-the-counter (OTC) cough- cold combination drug products to remove the combination of an oral bronchodilator (products containing ephedrine or its salts) and an expectorant, and to reclassify this combination drug product as Category II (not generally recognized as safe and effective for OTC use). FDA is also proposing to classify the combination of an oral bronchodilator and an oral nasal decongestant as Category II. FDA is issuing this notice of proposed rulemaking after considering data and information on the appropriateness of these combination drug products to treat mild asthma. Elsewhere in this issue of the Federal Register, FDA is proposing to amend the final monograph (FM) for OTC bronchodilator drug products to require additional labeling for all ingredients included in the FM. These proposed rules are part of FDA's ongoing review of OTC drug products.
Memorandum of Understanding on Environmental Contaminants in Fish and Shellfish, Between the United States Food and Drug Administration, Center for Food Safety and Applied Nutrition and the United States Environmental Protection Agency, Office of Water
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA's Center for Food Safety and Applied Nutrition (CFSAN) and the U.S. Environmental Protection Agency (EPA), Office of Water (OW). The purpose of this MOU is to establish a greater collaboration between CFSAN and OW regarding environmental contaminants in fish and shellfish and the safety of fish and shellfish for consumption by U.S. consumers.
Memorandum of Understanding Between the Food and Drug Administration and the State of Illinois, Emergency Management Agency, Bureau of Radiation Safety
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration and the State of Illinois, through the Illinois Emergency Management Agency, to continue to conduct a State as certifiers program in Illinois under the Mammography Quality Standards Act as amended by the Mammography Quality Standards Reauthorization Act of 1998.
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