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

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Expiration Dating of Unit- Dose Repackaged Drugs.'' The draft guidance is a proposed revision of section 480.200 of FDA's Compliance Policy Guide (CPG) (CPG 7132b.11). We are proposing to revise CPG 7132b.11 so that FDA enforcement policy regarding expiration dating of nonsterile unit-dose repackaged drugs under the agency's current good manufacturing practice (CGMP) regulations is substantially comparable to the expiration dating standards for such drugs set forth in the U.S. Pharmacopeia (USP).

This notice solicits interested parties to submit requests for review of the appropriateness of the payment amount for a particular intraocular lens furnished by an ambulatory surgical center.

This notice establishes the proposed allocations to States of FY 2005 funds for refugee \1\ social services under the Refugee Resettlement Program (RRP). The final notice will reflect amounts adjusted based upon final adjustments to FY 2002, FY 2003 and FY 2004 (October 1, 2001 through September 30, 2004) data submitted to ORR by States.

Pursuant to section 814 of the Native American Programs Act of 1974; as amended, 42 U.S.C., 2991b-1, the Administration for Native Americans (ANA) herein describes its proposed 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 rule 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.

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 012'' (Recognition List Number: 012), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The Food and Drug Administration (FDA) is announcing the availability for comments of a draft guidance document for industry (176) entitled ``Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances'' (VICH GL39). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to assist to the extent possible, in the establishment of a single set of recommended global specifications for new veterinary drug substances and medicinal products. It provides guidance through recommendations on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic chemical origin, and new medicinal products produced from them, which have not been registered previously in the United States, the European Union, or Japan.

In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice announces a meeting of the Advisory Panel on Medicare Education (the Panel) on June 21, 2005. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Useful Written Consumer Medication Information (CMI).'' CMI is written information developed for consumers about prescription drugs that is distributed to consumers when they have prescriptions filled. The guidance discusses general issues and makes recommendations on the content of useful written CMI.

The Office for Human Research Protections (OHRP), Office of Public Health and Science, Department of Health and Human Services (HHS), and the Food and Drug Administration (FDA), are soliciting public review and comment on a proposed research protocol entitled ``Precursor Preference in Surfactant Synthesis of Newborns.'' The proposed research would be conducted at the St. Louis Children's Hospital and supported by the National Heart, Lung and Blood Institute. Public review and comment are solicited regarding the proposed research protocol under the requirements of HHS and FDA regulations.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Antiviral Drug DevelopmentConducting Virology Studies and Submitting the Data to the Agency.'' This guidance is being issued to assist sponsors in developing and submitting nonclinical and clinical virology data, which are important to support clinical trials of antiviral agents. Nonclinical and clinical virology reports are essential components in the review of investigational antiviral drugs. The information in this guidance will facilitate the development of antiviral drug products.

This notice announces the establishment of the Medicaid Commission and discusses the group's purpose and charter. It also solicits nominations for members.

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.

Colorectal Cancer (CRC) is the second leading cause of cancer-related deaths in the United States, following lung cancer (1-American Cancer Society 2005, see Attachment D). Strong scientific evidence indicates that regular screening is effective in reducing CRC incidence and mortality (2Mandel 1993, 3Mandel 2000, 4Selby 1992, 5Kronburg 1996, 6Hardcastle 1996, see Attachment D). Screening rates for CRC are currently lower than other cancer screening services (7Seeff 2004). CRC screening is already occurring in some communities, either in an organized or an opportunistic setting. Some communities are planning to begin screening, but are still building their infrastructure and/or resources. The Centers for Disease Control and Prevention (CDC) announce the availability of funds in fiscal year (FY) 2005 for three to five cooperative agreements to implement demonstration programs designed to increase population-based CRC screening among persons 50 years and older in a geographically defined area, with screening efforts focused on persons 50 years and older with low incomes and inadequate or no health insurance coverage for CRC screening (priority population). Applicants will need to define the geographic area that their program will cover. Applicants will be asked to describe their current CRC screening efforts and to define what they need to increase CRC screening rates in these two populations: (1) The larger geographically-defined population; and (2) the priority sub-population within that geographically- defined area. CDC will choose among applicants based on specific evaluation criteria described in this RFA. These will be three year demonstration programs, pending availability of funds.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency'' 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 Phoenix Scientific, Inc. The NADA provides for the oral use of pyrantel pamoate paste for the removal and control of mature infections of tapeworms in horses and ponies.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. This meeting is open to the public. A description of the Council's functions is also included with this notice.

The Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) (we, our, the agencies) are proposing to establish a set of general principles for food standards. The adherence to these principles will result in standards that will better promote honesty and fair dealing in the interest of consumers and protect the public, allow for technological advances in food production, be consistent with international food standards to the extent feasible, and be clear, simple, and easy to use for both manufacturers and the agencies that enforce compliance with the standards. The proposed general principles will establish the criteria that the agencies will use in considering whether a petition to establish, revise, or eliminate a food standard will be the basis for a proposed rule. In addition, each agency may propose to establish, revise, or eliminate a food standard on its own initiative or may propose revisions to a food standard in addition to those a petitioner has requested. These proposed general principles are the agencies' first step in instituting a process to modernize their standards of identity (and any accompanying standards of quality and fill of container) and standards of composition.

The Family and Youth Services Bureau (FYSB) is accepting applications to provide support to public and private entities for the development and implementation of the Community-Based Abstinence Education Program for adolescents, ages 12 through 18, in communities across the country. This funding opportunity targets the implementation of community-based abstinence educational programs designed to: (a) Reduce the proportion of adolescents who engage in premarital sexual activity, including but not limited to sexual intercourse; (b) reduce the incidence of out-of-wedlock pregnancies among adolescents; and (c) reduce the incidence of sexually transmitted diseases among adolescents. Priority funding will be given to those entities that demonstrate a strong record of providing abstinence education among adolescents as defined by Section 510(b)(2) of Title V of the Social Security Act, which promotes a strong abstinence until marriage message to youth.

The National Institute on Drug Abuse, a component of the National Institutes of Health, Department of Health and Human Services (DHHS) seeks an agreement with a pharmaceutical or biotechnology company to test the hypotheses that vigabatrin may be a safe and effective medication for the treatment of cocaine and methamphetamine dependence. A body of literature relevant to preclinical studies of vigabatrin as a potential treatment agent for various types of substance dependence (including cocaine and methamphetamine) and a more limited body of literature concerning clinical results exists. As there are currently no medications approved by the U. S. Food and Drug Administration (FDA) for the treatment of cocaine and/or methamphetamine dependence, and cocaine and methamphetamine dependence have substantial negative public health impacts, the National Institute on Drug Abuse is interested in evaluating the safety and efficacy of vigabatrin for the treatment of cocaine and methamphetamine dependence. Rationale for Studying Vigabatrin in Stimulant(s) Dependence

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 requesting comments concerning the establishment of program priorities in the Center for Food Safety and Applied Nutrition (CFSAN) for fiscal year (FY) 2006. As part of its annual planning, budgeting, and resource allocation process, CFSAN is reviewing its programs to set priorities and establish work product expectations. This notice is being published to give the public an opportunity to provide input into the priority- setting process.

This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2006, as required by statute. Annual updates to the PPS rates are required by section 1888(e) of the Social Security Act (the Act), as amended by the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA), the Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) Benefits Improvement and Protection Act of 2000 (BIPA), and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), relating to Medicare payments and consolidated billing for SNFs. As part of this year's annual update, we are proposing to introduce refinements in the Resource Utilization Groups, version III (RUG-III), the case-mix classification system used under the SNF PPS.

Notice is hereby given that a noncompetitive grant award is being made to the Rural Community Assistance Program, Inc. to provide training and technical assistance to small communities struggling to deal with the safety and security of small and very small community water and wastewater treatment systems. This award addresses Congressional concern that many small and very small community water and wastewater treatment systems might be most vulnerable to terrorist attack, yet the least prepared to deal with the issues. The application is not within the scope of any existing or expected to be issued program announcement for the Fiscal Year 2005Rural Community Development Activities Program (RF) as authorized under the Community Services Block Grant Act of 1998, as amended; Sections 680(a)(3)(B) of the Community Opportunities Accountability, and Training and Educational Services (COATES) Act (Pub. L. 105-285). This application is expected to provide valuable on-site training and technical assistance to small and very small communities struggling to deal with the safety and security of small community water and wastewater treatment systems. This announcement is inviting application for a 12-month budget period and a 12 month project period. The funds are not being competed due to the Senate appropriation language in FY 2005 that directs the Office of Community Services to support a Rural Community Assistance Program Small Community Infrastructure Safety and Training and Technical project. Congress intends the funds to go to an organization that is capable of conducting a project that is national in scope that provides State, regional and national infrastructure safety training workshops and on- site technical assistance targeted to small and very small community water and wastewater treatment systems. Contact for Further Information: Administration for Children and Families, Office of Community Services, 370 L'Enfant Promenade, SW., Washington, DC 20447, Veronica Terrell(202) 401-5295, vterrell@acf.hhs.gov.

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), 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.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.'' This guidance presents FDA's general policy for implementing the channels of trade provision in the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food Quality Protection Act of 1996 (the FQPA), for food containing residues of pesticide chemicals, for which tolerances have been revoked, suspended, or modified pursuant to dietary risk considerations.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Devices; Medical Device Tracking'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This final rule removes 42 CFR part 50, subpart A, ``Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science,'' and replaces it with a new, more comprehensive part 93, ``Public Health Service Policies on Research Misconduct.'' The proposed part 93 was published for public comment on April 16, 2004. The final rule reflects both substantive and non-substantive amendments in response to public comments and to correct errors and improve clarity, but the general approach of the NPRM is retained. The purpose of the final rule is to implement legislative and policy changes applicable to research misconduct that occurred over the last several years, including the common Federal policies and procedures on research misconduct issued by the Office of Science and Technology Policy on December 6, 2000.

This notice is to inform interested parties of corrections made to the CCF Demonstration Program published on Friday, April 29, 2005. The following corrections should be noted: Under IV.6 Other Submission Requirements, the correct address to mail and hand deliver applications is: U.S. Department of Health and Human Services (HHS), Attention: Eduardo Hernandez, Administration for Children and Families Office of Community Services, Operations Center, Compassion Capital Fund Demonstration Program, 1515 Wilson Boulevard, Suite 100, Arlington, Virginia 22209. Phone: 1-800-281-9519. E-mail: OCS@lcgnet.com. The only changes to the CCF Demonstration Program Announcement are explicitly stated in this Notice of Correction. All applications must still be sent on or before the deadline date of June 13, 2005. For further information contact the OCS Grants Operations Center at the above phone number or address.

The Food and Drug Administration (FDA) is withdrawing approval of one new drug application (NDA). CollaGenex Pharmaceuticals, Inc., notified the agency in writing that PERIOSTAT (doxycycline hyclate) 20- milligram (mg) capsules were no longer marketed and requested that approval of NDA 50-774 be withdrawn. FDA has determined that PERIOSTAT (doxycycline hyclate) 20-mg capsules were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for doxycycline hyclate 20-mg capsules.

The Food and Drug Administration (FDA) is announcing a series of domestic public meetings to discuss the final regulation implementing section 306 (Maintenance and Inspection of Records) of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). The purpose of these public meetings is to provide to the public information and an opportunity to ask questions regarding the final rule.

The FTC and HHS are planning to host a public workshop, ``Marketing, Self-Regulation & Childhood Obesity,'' to explore self- regulatory marketing initiatives in the food and beverage industry that respond to concerns about childhood obesity. The event is open to the public and there is no fee for attendance. For admittance to the conference center, all attendees will be required to show a valid form of photo identification, such as a driver's license. The FTC will accept pre-registration for this workshop. Pre- registration is not necessary to attend, but is encouraged so that we may better plan this event. To pre-register, please e-mail your name and affiliation to the e-mail box for the workshop, at FoodMarketingtoKids@ftc.gov. When you pre-register, we collect your name, affiliation, and your e-mail address. This information will be used to estimate how many people will attend and better understand the likely audience for the workshop. We may use your e-mail address to contact you with information about the workshop. Under the Freedom of Information Act (FOIA) or other laws, we may be required to disclose the information you provide to outside organizations. For additional information, including routine uses permitted by the Privacy Act, see the Commission's Privacy Policy at https://www.ftc.gov/ftc/privacy.htm. The FTC Act and other laws the Commission administers permit the collection of this contact information to consider and use for the above purposes. Additional information about the workshop will be posted on the FTC's Web site at https://www.ftc.gov/bcp/workshops/foodmarketingtokids/ index.htm.

In compliance with he requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed date collection projects, the Office of the Director (OD), 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. Proposed Collection: Title: Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors42 CFR Part 50, Subpart F. Type of Information Collection Request: Revision of OMB No. 0925-0417, expiration date 09/31/2005. Need and Use of Information Collections: This is a request for OMB approval for the information collection and recordkeeping requirements contained in the final rule 42 CFR part 50, subpart F and Responsible Prospective Contractors: 45 CFR part 94. The purpose of the regulations is to promote objectivity in research by requiring institutions to establish standards which ensure that there is no reasonable expectation that the design, conduct, or reporting of research will be biased by a conflicting financial interest of an investigator. Frequency of Response: On occasion. Affected Public: Individuals or households; business or other for-profit; not-for-profit institutions; State local or tribal government. Type of Respondents: Any public or private entity or organization. The annual reporting burden is as follows: Estimated Number of Respondents: 42,800; Estimated Number of Responses per Respondent: 1.60; Average Burden Hours per Response: 3.40; and Estimated Total Annual Burden Hours Requested: 232,000. The annualized costs to respondents is estimated at: $8,120,000. Operating costs and/ or Maintenance costs are $4,633. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. For Further Information Contact: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Mikia Currie, Assistant Project Clearance Officer, Office of Extramural Research (OER) Office of Policy for Extramural Research Administration (OPERA), 6705 Rockledge Drive, Room 1198, Bethesda, MD 20892-7974 or call non-toll-free number (301) 435- 0941, e-mail your request including your address to: curriem@od.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

In compliance with the provisions of Section 3507(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comments on proposed data collection projects, the National Institutes of Health (NIH), National Cancer Institute (NCI) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on October 29, 2004 (Volume 69, No. 209, pages 63159-63160) 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 number. Proposed Collection: Title: Survey of Colorectal Cancer Screening Policies, Programs, and Systems in U.S. Health Plans. Type of Information Collection Request: New. Need and Use of Information collection: This study will obtain information on policies, programs, and practices for colorectal cancer screening among health plans in the U.S. The purpose of the study is to assess (1) Health plan policies, programs, and practices for colorectal cancer screening; (2) health plan activities in response to the National Committee on Quality Assurance's new Health Employer Data Information Set measure for colorectal cancer screening; and (3) characteristics of health plans and plan policies and activities that may be associated with higher rates of colorectal cancer screening. A questionnaire will be administered by mail or Internet using a national sample of health plans. Study participants will be health plan medical directors or administrators, and they will select their preferred response mode. Burden estimates are as follows:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on July 19, 2004 on page 43003 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. Proposed Collection: Title: Evaluation of National Cancer Institute's Central Institutional Review Board to Improve Cancer Clinical Trials System. Type of Information Collection Request: NEW. Need and Use of Information Collection: This study will evaluate the effectiveness of the Central Institutional Review Board (CIRB), a pilot project designed to streamline the protocol activation process by conducting human subject protection reviews that can be utilized by local Institutional Review Boards (IRB) for facilitated approval of multi-institutional, NCI- sponsored Phase 3 clinical trials. This evaluation includes two surveys that will be made available online to minimize respondent burden. The CIRB survey will assess acceptance level and satisfaction of local IRB chairs, coordinators, and principal investigators with the CIRB. The Cooperative Group Staff Survey will assess the opinions and experiences of the operations and regulations staff of the nine Clinical Trials Cooperative Groups about CIRB operations, office processes, and procedures. The findings will provide valuable information concerning whether the CIRB is meeting its intended goals and will provide recommendations for change and further study. Frequency of Response: Once. Affected Public: Registered members of the CIRB and Clinical Trials Cooperative Group Staff. Type of Respondents: IRB chairs, IRB coordinators, principal investigators, and the operations and regulations staff of Clinical Trials Cooperative Groups. The annualized cost to respondents is estimated at $5,500. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Estimated Number of Respondents: 279. Estimated Number of Responses per Respondent: 1. Average Burden per Response: 0.50 hours. Estimated Total Annual Burden Hours Requested: 139.50. The total burden estimate per respondent is shown below.