Department of Health and Human Services 2005 – Federal Register Recent Federal Regulation Documents

NICEATM announces the availability of revised analyses for four in vitro test methods proposed for detecting ocular corrosives and severe irritants [the Bovine Corneal Opacity and Permeability (BCOP) assay, the Hen's Egg TestChorion Allantoic Membrane (HET-CAM), the Isolated Rabbit Eye (IRE) assay, and the Isolated Chicken Eye (ICE) assay]. A revised list of proposed reference substances for validation studies on in vitro test methods for identifying ocular corrosives and severe irritants is also available. The revised analyses and list of proposed reference substances are provided in an addendum that is applicable to each of four draft Background Review Documents (BRDs) that were released to the public on November 3, 2004. The NICEATM invites public comment on the information provided in this addendum. Copies of the draft BRDs and addendum may be obtained on the ICCVAM/ NICEATM Web site (https://iccvam.niehs.nih.gov see ``Reports & Background Documents''), or by contacting NICEATM at the address given below.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The ANADA provides for use of tiamulin concentrate solution to prepare medicated drinking water for the treatment of swine dysentery and swine pneumonia.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Allergen Labeling of Food Products Consumer Preference Survey and Experimental Study on Allergen Labeling of Food Products'' 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 amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA provides for a period of protection from reinfestation with two species of external parasites following topical administration of doramectin solution on cattle.

In accordance with the requirements of the Privacy Act of 1974, as amended, this Notice announces the establishment of a CMP that CMS plans to conduct with the Washington Department of Social and Health Services (DSHS). We have provided background information about the proposed Matching Program in the SUPPLEMENTARY INFORMATION section below. The Privacy Act requires that CMS provide an opportunity for interested persons to comment on the proposed matching program. We may defer implementation of this Matching Program if we receive comments that persuade us to defer implementation. See DATES section below for comment period.

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Head Start Bureau, under the authority of Sections 640(a)(2)(C) and 648(c)(4) (42 U.S.C. 9843), is making available $3 million annually for each of the next five years, to support a cooperative agreement to provide family literacy training and technical assistance to Head Start and Early Head Start programs based on proven effective practices substantiated by research findings. This project will help grantees and delegate agencies nationwide to improve the quality and positive outcomes of family literacy services they provide. This includes programs serving American Indians, Alaska Natives, migrant and seasonal workers, and English language learners.

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 and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. In addition, the proposed rule describes proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. This proposed rule would also change the requirement for physician oversight of mid-level practitioners in critical access hospitals (CAHs). These changes would be applicable to services furnished on or after January 1, 2006.

This final notice describes the evaluation criteria we will use to evaluate the Quality Improvement Organizations (QIOs) under their contracts with us, for efficiency and effectiveness 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 7th SOW includes Tasks 1 through 4, with subtasks included under all tasks, excluding Task 4. QIOs were awarded contracts for the 7th SOW, or 7th Round, for 3 years, with staggered starting dates beginning August 2002, November 2002, and February 2003. This final notice also responds to the public comments received regarding the evaluation criteria published in July 2004.

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 PCT/US04/ 31967 filed September 28, 2004 from U.S. provisional application 60/ 507,034 (E-276-2003/0-US-01), entitled ``HIV-Dependent Expression Constructs and Uses Therefor'' (E-276-2003/0-PCT-02), (Inventors: Yuntao Wu and Jon Marsh), to Revix Technology LLC (hereafter Revix), having a place of business in Manassas, Virginia. The patent rights in these inventions have been assigned to the United States of America.

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 amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments as color additives in ingested drugs. This action is in response to a petition filed by EM Industries, Inc.

This notice requests nominations for individuals to serve on the Advisory Panel on Medicare Education (the Panel). The Panel advises and makes recommendations to the Secretary of the Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on opportunities for CMS to optimize the effectiveness of the National Medicare Education Program and other CMS programs that help Medicare beneficiaries understand the Medicare program and the range of health plan options available. Nominees must be knowledgeable in the field of labor and retirement benefits.

This notice requests nominations for consideration for membership on the Medicare Coverage Advisory Committee (MCAC).

The CERHR announces the availability of the expert panel report on styrene on July 18, 2005 from the CERHR Web site (https:// cerhr.niehs.nih.gov) or in print from the CERHR (see ADDRESSES below). The expert panel report is an evaluation of the reproductive and developmental toxicity of styrene conducted by a 13-member expert panel composed of scientists from the federal government, universities, and private organizations. The CERHR invites the submission of public comments on this expert panel report (see SUPPLEMENTARY INFORMATION below). The CERHR previously solicited public comment on the draft version of this expert panel report (Federal Register Vol. 70, No. 45 pp. 11680-11681). Public deliberations by the panel took place on June 1-3, 2005, at the Holiday Inn Old Town Select Alexandria, Virginia to review and revise the draft expert panel report and reach conclusions regarding whether exposure to styrene is a hazard to human development or reproduction. The expert panel also identified data gaps and research needs.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director, Office of Science Policy, Office of Science Education, National Institutes of Health 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 has not been previously published in the Federal Register. The purpose of this notice is to allow 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 number. Proposed Collection: Title: The Effectiveness of the NIH Curriculum Supplements and Workshops Survey. Information Collection Request: NEW. New and Use of Information Collection: The survey will attempt to assess the effectiveness of the NIH curriculum supplements in aiding teachers to teach science in a more engaging and interactive way. The supplements help k-12 educators teach science in more engaging and effective ways by featuring the latest NIH research. A typical supplement contains two weeks of student activities on the science behind a health topic, such as cancer, sleep or obesity. Web-based simulations, animations and experiments enhance the ``pencil and paper'' activities. In addition to developing and distributing the supplements, OSE conducts professional workshops to help teachers successfully implement these lessons with their students. Since January 2000, over 3,000 teachers have attended an OSE workshop. Assessing the effectiveness of the NIH Curriculum Supplements and teacher workshops is critical to determining if OSE is successfully fulfilling its mission. OSE has the database infrastructure in place to easily collect customer satisfaction data from supplement requests and workshops attendees. At present, we do not have clearance to contact our customers to determine how NIH resources are meeting their educational needs.

The Food and Drug Administration (FDA) is correcting the single-ingredient roxarsone Type A medicated article that may be used to formulate three-way, combination drug Type C medicated broiler chicken feeds containing semduramicin, virginiamycin, and roxarsone under a new animal drug application (NADA) recently approved for Phibro Animal Health. FDA is also amending the animal drug regulations to reflect two roxarsone Type A medicated articles approved under separate new animal drug applications (NADAs) for different conditions of use. This action is being taken to improve the accuracy of the agency's regulations.

The Food and Drug Administration (FDA) is announcing the availability of two draft manuals entitled ``Managing Food Safety: A Manual for the Voluntary Use of HACCP Principles for Operators of Food Service and Retail Establishments'' (the ``Operator's Manual'') and ``Managing Food Safety: A Regulator's Manual for Applying HACCP Principles to Risk-Based Retail and Food Service Inspections and Evaluating Voluntary Food Safety Management Systems'' (the ``Regulator's Manual''). The Operator's Manual presents FDA's best advice to retail and foodservice operators for voluntarily implementing food safety management systems based on hazard analysis and critical control point (HACCP) principles to reduce the occurrence of foodborne illness risk factors. The Regulator's Manual is intended to assist State, local, and tribal regulatory authorities in identifying and assessing control of foodborne illness risk factors during routine inspections of retail and foodservice establishments by providing a risk-based inspection methodology.

The Food and Drug Administration (FDA) is announcing a public meeting to obtain expert comment and consultation from stakeholders to help the agency to define and permit the voluntary use on food labeling of the term ``gluten-free''. The meeting will focus on food manufacturing, analytical methods, and consumer issues related to reduced levels of gluten in food. We request that those who wish to speak at the meeting, or otherwise provide FDA with their written or oral comments, focus on the questions set out in this document.

This notice is to inform the public of SAMHSA's anticipated grant funding opportunities for FY 2006, based on the President's FY 2006 budget request. All information provided is tentative and preliminary. These plans may change and final figures will not be available until after SAMHSA receives its 2006 appropriation. In January 2005, SAMHSA ceased publishing notices of grant funding opportunities in the Federal Register, consistent with the Department of Health and Human Services management objectives. Announcements are instead posted on https://www.Grants.gov and on SAMHSA's Web site at https://www.samhsa.gov. Interested applicants should visit these Web sites for specific information about these programs as it becomes available. Applicants should also be aware that all the necessary information to apply for grant funds will continue to be available at SAMHSA's two national clearinghouses: the National Clearinghouse for Alcohol and Drug Information (NCADI)-1-800-729-6686for substance abuse prevention or treatment grants; and the National Mental Health Information Center-1-800-789-CMHS (2647)for mental health grants.

The Administration for Native Americans (ANA) herein issues final interpretive rules, general statement of policy, and rules of agency procedure or practice in relation to the Social and Economic Development Strategies (SEDS) project SMART NA Communities (Strengthening Marriages and Relationships in Tribal and Native American Communities). For FY 2005, ANA reserved an amount of funding under the SEDS program to fund projects that are beneficial to the development of healthy Native American communities. ANA has decided to participate in ACF's Healthy Marriage Initiative, and intends to use the reserved SEDS funds to support projects that improve child well- being by removing barriers associated with forming and retaining healthy families and marriages in Native American communities. Under the statute, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, statements of general policy, and rules of agency procedure or practice, and to give notice of the final adoption of such changes at least 30 days before the changes become effective. The notice also provides additional information about ANA's plan for administering the programs.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``Medicare Retiree Drug Subsidy Program (RDSP), System No. 09-70-0550.'' Under section 1860D-22 of the Social Security Act (the Act), employers and unions who continue to offer prescription drug coverage to their qualifying covered retirees are eligible to receive a tax-free subsidy for allowable drug costs. This amended provision of the Act is mandated by section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). A qualifying covered retiree is a Part D eligible individual who is a participant or the spouse or dependent of a participant; covered under employment-based retiree health coverage that qualifies as a qualified retiree prescription drug plan; and not enrolled in a Part D plan. Employment- Based Retiree Health Coverage is defined as coverage of health care costs under a group health plan based on an individual's status as a retired participant in the plan, or as the spouse or dependent of a retired participant. The term includes coverage provided by voluntary insurance coverage as a result of a statutory or contractual obligation. The Medicare prescription drug benefit and retiree drug subsidy represent additional funding sources that can help employers and unions continue to provide high quality drug coverage for their retirees. The purpose of this system is to collect and maintain information on individuals who are qualifying covered retirees so that accurate and timely subsidy payments may be made to plan sponsors who continue to offer actuarially equivalent prescription drug coverage to the qualifying covered retirees. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency, or by a contractor or consultant; (2) support constituent requests made to a congressional representative; (3) support litigation involving the agency; and (4) combat fraud and abuse in certain health benefits programs. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, 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 the draft guidance entitled ``The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System 9.'' The draft guidance document is intended to assist facilities and their personnel in meeting the Mammography Quality Standards Act (MQSA) final regulations.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``State Petitions for Exemption From Preemption'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Office of Community Services (OCS) within the Administration for Children and Families (ACF) announces that competing applications will be accepted for a new grant pursuant to the Secretary's authority under section 678(A) of the Community Services Block Grant (CSBG) Act, as amended, by the Community Opportunities, Accountability, and Training and Educational Services (COATES) Human Services Reauthorization Act of 1998 (Pub. L. 105-285). These activities must fund training and technical assistance resources for the Community Services Network to ensure that the needs of eligible entities and programs relating to improving program quality (including quality of financial management practices) are addressed to the maximum extent feasible; and incorporate mechanisms to ensure responsiveness to local needs. The proposed grants will fund training and technical assistance resources for the Community Services Network focusing on improving the quality of programs carried out under the CSBG act and the delivery of healthy marriage strategies among low income people served by local community action agencies. Specifically, OCS will offer one-year grants to fund a one year project period for the creation and dissemination of ``best practice'' technical assistance materials from local community organizations, including those that are faith-based, that have demonstrated success in promoting or sustaining healthy marriages among clients as part of an overall strategy to help low-income people achieve family and child development, and/or self-sufficiency goals. Special emphasis is being placed on the development and dissemination of ``best practice'' materials that focus on a wide range of low-income populations, including racial and ethnic minorities.

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 National Bureau of Standards, Van Ness Street, in Washington, DC, 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: National Bureau of Standards, Van Ness Street. Location: Washington, DC. Job Titles and/or Job Duties: All physicists that worked in the Radioactivity LabEast BuildingBuilding 2. Period of Employment: From 1943 through 1952.

This proposed rule would set forth an update to the 60-day national episode rates and the national per-visit amounts under the Medicare prospective payment system for home health agencies. We are also proposing to implement the revised area labor market Metropolitan Statistical Area designations for calendar year 2006.

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.''

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.

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.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a hearing of the Citizens' Health Care Working Group mandated by section 1014 of the Medicare Modernization Act. The Hearing will be conducted by the Hearings Committee of the Working Group.

This notice is to inform interested parties of corrections made to the Demonstration Projects that Improve Child Well-Being by Fostering Healthy Marriages Within Underserved Communities program announcement that published on June 8, 2005. The following corrections should be noted: Under Section III. 1 Eligible Applicants, following `Non-profits that do not have 501 (c) (3) status with the IRS, other than institutions of higher education please add the following eligible applicants: Native American tribal governments (Federally recognized) and Native American tribal organizations (other than Federally recognized tribal governments). The final list of eligible applicants for this announcement should read: ``1. Eligible Applicants:

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the State of Iowa, through the Iowa Department of Public Health, Bureau of Radiological Health (the Department), and FDA. The purpose is to authorize the state of Iowa, through the Department, to continue to conduct a State as certifiers program in Iowa under the Mammography Quality Standards Act as amended by the Mammography Quality Standards Reauthorization Act of 1998.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of tulathromycin solution in cattle and in swine, by injection, for the management of respiratory disease. FDA is also amending the regulations to add the acceptable daily intake for total residues of tulathromycin and tolerances for residues of tulathromycin in edible tissues of cattle and swine.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Exports: Notification and Recordkeeping Requirements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 (HHS), is contemplating the grant of an exclusive license worldwide to practice the invention embodied in: Provisional Patent Application Serial No. 60/607,031 filed 9/3/2004, and Provisional Patent Application Serial No. 60/618,275 filed 10/12/2004 titled ``Method for Diagnosis of Atherosclerosis'' referenced at HHS as E-276-2004/0-US-01 and E-276-2004/0-US-01 respectively to Biosite, Inc., having a place of business in the state of California. The field of use may be limited to an FDA approved clinical diagnostic product for atherosclerosis. The United States of America is the assignee of the patent rights in this invention. The territory may be worldwide. This announcement is the first notice to grant an exclusive license to this technology.