Department of Health and Human Services January 2005 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval to Market a New Drug
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.
Draft Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Substances; Chemistry, Manufacturing, and Controls Information; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDAs: Impurities in Drug Substances; Chemistry, Manufacturing, and Controls Information.'' This draft guidance provides recommendations on what chemistry, manufacturing, and controls information to include regarding the reporting, identification, and qualification of impurities in drug substances produced by chemical synthesis when submitting documentation for an abbreviated new drug application (ANDA), drug master file (DMF), or a supplement to support changes in drug substance synthesis or process.
Prospective Grant of Exclusive License: Commercializing Instruments, Reagents and Related Products Used for Template-Dependent Sequencing-by-Synthesis of Nucleic Acids at the Single Molecule Level, Wherein a Polymerase Carries the Donor Label
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 Patent Applications U.S. 60/151,580, filed August 29, 1999; PCT/US00/23736, filed August 29, 2000 and U.S. 10/070,053, filed June 10, 2002; entitled ``High Speed Parallel Molecular Nucleic Acid Sequencing'', to VisiGen Biotechnologies, Inc., having a place of business in Houston, Texas. The patent rights in this invention have been assigned to the United States of America.
OIG Supplemental Compliance Program Guidance for Hospitals
This Federal Register notice sets forth the Supplemental Compliance Program Guidance (CPG) for Hospitals developed by the Office of Inspector General (OIG). Through this notice, the OIG is supplementing its prior compliance program guidance for hospitals issued in 1998. The supplemental CPG contains new compliance recommendations and an expanded discussion of risk areas, taking into account recent changes to hospital payment systems and regulations, evolving industry practices, current enforcement priorities, and lessons learned in the area of corporate compliance. The supplemental CPG provides voluntary guidelines to assist hospitals and hospital systems in identifying significant risk areas and in evaluating and, as necessary, refining ongoing compliance efforts.
Administrative Costs for Children in Title IV-E Foster Care
The Administration for Children and Families (ACF) is proposing to amend the regulations for Child and Family Services with respect to title IV-E administrative costs and eligibility determinations and re-determinations for title IV-E foster care recipients and foster care ``candidates.'' This Notice of Proposed Rule Making (NPRM) proposes rules to implement title IV-E foster care eligibility and administrative cost provisions in sections 472 and 474 of the Social Security Act (the Act) and incorporates previously issued policy guidance.
Medicare Program; Meeting of the Advisory Board on the Demonstration of a Bundled Case-Mix Adjusted Payment System for End-Stage Renal Disease Services
This notice announces the first public meeting of the Advisory Board on the Demonstration of a Bundled Case-Mix Adjusted Payment System for End-Stage Renal Disease (ESRD) Services. Notice of this meeting is required by the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Advisory Board will provide advice and recommendations with respect to the establishment and operation of the demonstration mandated by section 623(e) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. This notice also announces the appointment of eleven individuals to serve as members of the Advisory Board, including one individual to serve as co-chairperson, and one additional co-chairperson, who is employed by CMS.
High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing
The Food and Drug Administration (FDA) is announcing an opportunity for a hearing on the agency's proposal to withdraw approval of 13 new drug applications (NDAs) from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications.
National Institutes of Health Training Grants
The National Institutes of Health (NIH) proposes to amend the existing regulations governing its training grants to reflect applicability of the regulations to institutional training grants supporting pediatric research training.
Medicare Program; Demonstration of Coverage of Chiropractic Services Under Medicare
This notice announces the implementation of a demonstration mandated under Section 651 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), which will expand coverage of chiropractic services under Medicare beyond the current coverage for manipulation to correct a neuromusculoskeletal condition. Chiropractors will be permitted to bill Medicare for diagnostic and other services that a chiropractor is legally authorized to perform by the State or jurisdiction in which such treatment is provided. The demonstration will be conducted in four sites, two urban and two rural; one site in each area type must be a health professional shortage area (HPSA). Any chiropractor that provides services in these geographic areas will be able to participate in the demonstration. Any beneficiary enrolled under Medicare Part B, and served by chiropractors practicing in these sites would be eligible to receive services. Physician approval would not be required for these services. The statute requires that the demonstration be budget neutral. We anticipate that the demonstration will begin in April 2005 and operate for two years.
Medicare Program: Re-Chartering of the Advisory Panel on Medicare Education (APME) and Notice of the APME Meeting-February 24, 2005
This notice announces the renewal of the charter of 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 and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. The charter renewal was signed by the Secretary on January 14, 2005. The charter will terminate on January 14, 2007, unless renewed by the Secretary. In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice also announces a meeting of the Panel on February 24, 2005. This meeting is open to the public.
Medicare Program; Meeting of the Medicare Coverage Advisory Committee-March 29, 2005
This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC). The Committee provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting concerns usual care of chronic wounds. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare Program; Establishment of the Medicare Advantage Program
This final rule implements provisions of the Social Security Act (the Act) establishing and regulating the Medicare Advantage (MA) program. The MA program was enacted in Title II of The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) on December 8, 2003. The MA program replaces the Medicare+Choice (M+C) program established under Part C of title XVIII of the Act, while retaining most key features of the M+C program. The MA program attempts to broadly reform and expand the availability of private health plan options to Medicare beneficiaries. This final rule responds to public comments on a proposed rule published on August 3, 2004 (FR 69 46866). EFFECTIVE DATE: These regulations are effective March 22, 2005 except for the following changes which will become effective on January 1, 2006: amendment of Sec. 417.600(b); removal of Sec. 417.602 through Sec. 417.638; and amendments to Sec. 417.832(d); and Sec. 417.840.
Medicare Program; Medicare Prescription Drug Benefit
This final rule implements the provisions of the Social Security Act (the Act) establishing and regulating the Medicare Prescription Drug Benefit. The new voluntary prescription drug benefit program was enacted into law on December 8, 2003 in section 101 of Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). Although this final rule specifies most of the requirements for implementing the new prescription drug program, readers should note that we are also issuing a closely related rule that concerns Medicare Advantage organizations, which, if they offer coordinated care plans, must offer at least one plan that combines medical coverage under Parts A and B with prescription drug coverage. Readers should also note that separate CMS guidance on many operational details appears or will soon appear on the CMS website, such as materials on formulary review criteria, risk plan and fallback plan solicitations, bid instructions, solvency standards and pricing tools, plan benefit packages. The addition of a prescription drug benefit to Medicare represents a landmark change to the Medicare program that will significantly improve the health care coverage available to millions of Medicare beneficiaries. The MMA specifies that the prescription drug benefit program will become available to beneficiaries beginning on January 1, 2006. Generally, coverage for the prescription drug benefit will be provided under private prescription drug plans (PDPs), which will offer only prescription drug coverage, or through Medicare Advantage prescription drug plans (MA PDs), which will offer prescription drug coverage that is integrated with the health care coverage they provide to Medicare beneficiaries under Part C of Medicare. PDPs must offer a basic prescription drug benefit. MA-PDs must offer either a basic benefit or broader coverage for no additional cost. If this required level of coverage is offered, MA-PDs or PDPs, but not fallback PDPs may also offer supplemental benefits through enhanced alternative coverage for an additional premium. All organizations offering drug plans will have flexibility in the design of the prescription drug benefit. Consistent with the MMA, this final rule also provides for subsidy payments to sponsors of qualified retiree prescription drug plans to encourage retention of employer-sponsored benefits. We are implementing the drug benefit in a way that permits and encourages a range of options for Medicare beneficiaries to augment the standard Medicare coverage. These options include facilitating additional coverage through employer plans, MA-PD plans and high-option PDPs, and through charity organizations and State pharmaceutical assistance programs. See sections II.C, II.J, and II.P, and II.R of this preamble for further details on these issues. The proposed rule identified options and alternatives to the provisions we proposed and we strongly encouraged comments and ideas on our approach and on alternatives to help us design the Medicare Prescription Drug Benefit Program to operate as effectively and efficiently as possible in meeting the needs of Medicare beneficiaries.
List of Drugs for Which Pediatric Studies Are Needed
The National Institutes of Health (NIH) is providing notice of a ``List of Drugs for Which Pediatric Studies Are Needed.'' The NIH developed the list in consultation with the Food and Drug Administration (FDA) and pediatric experts, as mandated by the Best Pharmaceuticals for Children Act. This list adds to the previously published lists prioritizing drugs most in need of study for use by children to ensure the safety and efficacy of their medication. The NIH will update the list at least annually until the Act expires on October 1, 2007.
From Concept to Consumer: Center for Biologics Evaluation and Research Working With Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies; Public Workshop; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until January 27, 2006, the comment period for the notice of public workshop and request for comments published in the Federal Register of August 31, 2004 (69 FR 53077). FDA is reopening the comment period to allow interested persons additional time to submit comments and to receive any new information.
Notice of Appeal
By designation of the Administration for Children and Families, a member of the Departmental Appeals Board has been appointed as the presiding officer for an appeal of the Administration for Children and Families' (ACF) disapproval of an amendment to the plan of the New York State Office of Children and Family Services for implementing title IV-E of the Social Security Act (Foster Care and Adoption Assistance). The purpose of this notice is to give interested parties an opportunity to participate. Requests To Participate: Requests to participate as a party or as amicus curiae must be submitted to the Departmental Appeals Board in the form specified at 45 CFR 213.15 by February 11, 2005. Within that time, those persons, groups, or organizations seeking participation as parties or amici may file petitions or request extensions of time for submitting petitions to participate, and may also contact the Board to obtain copies of the briefs that the parties have filed.
Amendment To Extend for One Year the January 24, 2003, Declaration Regarding Administration of Smallpox Countermeasures, as Amended on January 24, 2004
Concern that terrorists may have access to the smallpox virus and attempt to use it against the American public and United States Government facilities abroad continues to exist. The January 24, 2003, declaration regarding administration of smallpox countermeasures, as amended on January 24, 2004, is extended for one year until and including January 23, 2006.
Government-Owned Inventions; Availability for Licensing
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.
Government-Owned Inventions; Availability for Licensing
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.
Prospective Grant of an Exclusive License: Therapeutics for the Treatment of Autoimmune Disease
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent No. 6,083,503, entitled ``Interleukin-2 stimulated T lymphocyte cell death for the treatment of autoimmune diseases, allergic responses, and graft rejection'' (DHHS Reference E-137-1991/0-US-03); U.S. Patent No. 5,989,546 entitled ``Interleukin-2 stimulated T lymphocyte cell death for the treatment of allergic responses'' (DHHS Reference E-137-1991/0- US-04); U.S. Patent No. 5,935,575, entitled ``Interleukin-4 stimulated T lymphocyte cell death for the treatment of allergic disorders'' (DHHS Reference E-151-1992/0-US-11); U.S. Patent Application No. 08/431,644 filed May 2, 1995 entitled ``Modified Myelin Basic Protein Molecules'' (DHHS Reference E-033-1996/0-US-01); and U.S. Patent Application No. 08/482,114 filed June 7, 1995 entitled ``Modified Proteolipid Protein Molecules'' (DHHS Reference E- 128-1996/1-US-01); to Apogenix Biotechnology AG, having a place of business in Heidelberg, Germany. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory will be worldwide and the field of use may be limited to therapeutics for the treatment of Multiple Sclerosis.
National Heart, Lung, and Blood Institute (NHLBI); Opportunity for a Cooperative Research and Development Agreement (CRADA) to Identify and Explore Epigenetic Regulatory Elements for Diagnostic and Therapeutics Purposes
The National Heart, Lung, and Blood Institute (NHLBI) is seeking Cooperative Research and Development Agreement (CRADA) collaborator(s) to work with investigators in the Laboratory of Molecular Immunology (LMI) to identify epigenetic regulatory elements that may be involved in the disease development of T and/or B cell leukemia/lymphoma and other cancers via genome-wide analysis of acetylation islands using the Genome-Wide Mapping Technique (GMAT). Representative disease-specific acetylation islands will be explored for diagnostic and therapeutic purposes.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Allergen Labeling of Food Products Consumer Preference Survey and Experimental Study on Allergen Labeling of Food Products
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 a voluntary consumer survey entitled ``Allergen Labeling of Food Products Consumer Preference Survey'' and an experimental study entitled ``Experimental Study on Allergen Labeling of Food Products.''
Draft Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Nonclinical Safety Evaluation of Drug Combinations.'' The guidance provides recommendations on nonclinical approaches to support the clinical study and approval of fixed-dose combination products (FDCs), copackaged products, and adjunctive therapies.
Establishment of Vaccination Clinics; User Fees for Investigational New Drug (IND) Influenza Vaccine Services and Vaccines
We are amending 42 CFR part 70 to establish vaccination clinics and a user fee in connection with the administration of vaccination services and vaccine. On December 7, 2004, HHS Secretary Tommy G. Thompson announced the purchase of 1.2 million doses of GlaxoSmithKline (GSK) influenza vaccine, Fluarix, for distribution to areas most in need as determined by State public health authorities. The Fluarix vaccine has been approved in seventy-eight foreign countries, and FDA has recently reviewed extensive manufacturing and summary clinical information and conducted an inspection of the GSK manufacturing facility in Germany to determine that this vaccine, although not licensed in the United States, is suitable for use under an Investigational New Drug application (IND). The Food and Drug Administration (FDA) reviewed GSK's IND application as well as the clinical protocol and manufacturing data. CDC and CDC's Institutional Review Board approved the GSK flu vaccine response protocol including the informed consent document. To ensure that the vaccine is properly administered to individuals identified to be most at risk and facilitate compliance with IND requirements, CDC is establishing vaccination clinics. CDC is proceeding without delay because of the unprecedented nature of this season's influenza vaccine shortage caused by contamination problems with Chiron Corporation's production facility in the United Kingdom, which effectively cut in half the expected United States supply of inactivated influenza vaccine. A user fee is being established in order to recoup the costs associated with administering the vaccine and for the vaccine itself. All individuals, other than those who are enrolled in Medicare Part B, will be required to pay the user fee.
Mandatory Guidelines for Federal Workplace Drug Testing Programs
In the Federal Register notice of April 13, 2004 (69 FR 19644), the Department of Health and Human Services (``HHS'' or ``Department'') published final changes to the Mandatory Guidelines for Federal Workplace Drug Testing Programs. These changes established specimen validity testing standards and reporting procedures for Federal agency urine specimens collected under the Mandatory Guidelines for Federal Workplace Drug Testing Programs. These changes to the Mandatory Guidelines were subject to further comment only on the creatinine criterion that is part of the requirement to report a urine specimen as substituted because the Department based this criterion on information received after the comment period on the proposed changes published on August 21,2001 closed. After reviewing the comments received regarding this issue, the Department has concluded that the 2 mg/dL creatinine criterion established in the April 13, 2004, Federal Register notice (69 FR 19644) for a substituted specimen is the appropriate cutoff concentration to use for reporting a urine specimen as substituted.
2005 White House Conference on Aging Policy Committee
Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given of the fourth Policy Committee meeting concerning planning for the 2005 White House Conference on Aging. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the contact person listed below in advance of the meeting.
Government-Owned Inventions; Availability for Licensing
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.
National Institute of Biomedical Imaging and Bioengineering; Notice of Public Comment Period
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is developing its first 5-year strategic plan (2005-2009), and invites the public to provide input regarding NIBIB's areas of scientific emphasis, operational emphasis, and strategic priorities. The public is invited to provide comments via the NIBIB Web site.
Meeting of the Presidential Advisory Council on HIV/AIDS
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 included also with this notice.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request the Office of Management and Budget (OMB) to allow the proposed information collection project: ``National Study of the Hospital Adverse Event Reporting Survey''. In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
Proposed Collection; Comment Request; Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial
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.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.
Request for Public Comment on a Written Request Issued by the Food and Drug Administration on the Use of Meropenem for the Treatment of Complicated Intra-Abdominal Infections in Preterm and Term Newborn and Infant Patients Younger Than 91 Days of Age
The National Institutes of Health (NIH) is requesting public comment on the following Written Request issued by the Food and Drug Administration (FDA) for off-patent drugs as defined in the Best Pharmaceuticals for Children Act (BPCA). The Written Request was referred to the NIH by the FDA as required by the BPCA. The Written Request was developed following formulation of an NIH-generated priority list, which prioritizes certain drugs most in need of study for use by children. The priority list was produced in consultation with the FDA, other NIH Institutes and Centers, and pediatric experts, as mandated by the BPCA. The studies that are described in the Written Request are intended to characterize the safety, efficacy, and pharmacokinetics of the drug for optimum use in pediatric patients.
Availability of Final Toxicological Profiles
This notice announces the availability of the sixteenth set of final toxicological profiles of priority hazardous substances prepared by ATSDR. This set comprises two new and three updated profiles.
State Children's Health Insurance Program (SCHIP); Redistribution of Unexpended SCHIP Funds From the Appropriation for Fiscal Year 2002
This notice with comment period describes the procedure for redistribution of States' unexpended Federal fiscal year (FY) 2002 SCHIP allotments remaining at the end of FY 2004 to those States that fully expended such allotments. These redistributed allotments will be available through the end of FY 2005 (September 30, 2005).
Public Information Regulations; Withdrawal
The Food and Drug Administration (FDA) published in the Federal Register of September 2, 2004, a direct final rule to incorporate exemptions one, two, and three of the Freedom of Information Act (FOIA) into FDA's public information regulations. The purpose was to implement more comprehensively the exemptions contained in FOIA. The comment period closed November 16, 2004. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
Privacy Act of 1974; Report of New System
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system of records, called the ``Cytology Personnel Record System (CYPERS), HHS/CMS/CMSO, 09-70- 0543.'' The primary purpose of CYPERS is to assure CMS of the accuracy and reliability of gynecologic cytology testing by compliance with the CLIA statutory requirements. This will be accomplished by tracking and monitoring the enrollment, participation, and performance of individual cytotechnologists and physicians participating in CMS approved gynecologic cytology proficiency testing programs. Information retrieved from this system of records will be used to support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; support constituent requests made to a Congressional representative; and support litigation involving the agency. We have provided background information about the proposed system in the SUPPLEMENTARY INFORMATION section, below. Although the Privacy Act requires only that the ``routine use'' portion of the system be published for comment, CMS invites comments on all portions of this notice. See EFFECTIVE DATES section for comment period.
New Animal Drugs For Use in Animal Feeds; Decoquinate
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Alpharma Inc. The supplemental NADAs provide for the use of single-ingredient decoquinate and chlortetracycline Type A medicated articles to make two-way Type B and Type C medicated feeds for cattle at a broader range of concentrations.
2nd NVAC Workshop on Strengthening the Supply of Vaccines in the U.S.
The Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Program Office is sponsoring the ``2nd NVAC Workshop on Strengthening the Supply of Vaccines in the U.S.'' The purpose of this workshop is to bring stakeholders together to: Develop a progress report on the recommendations made in 2002; identify both continuing and new factors that may threaten a stable vaccine supply; and outline specific actions that can have a durable effect in resolving impediments to the consistent and reliable availability of approved vaccines. The meeting is open to the public.
New Animal Drugs for Use in Animal Feeds; Melengestrol
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 Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of a melengestrol acetate liquid Type A medicated article to make Type C medicated feeds for heifers fed in confinement for slaughter and for heifers intended for breeding.
New Animal Drugs; Change of Sponsor's Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's address for Alstoe, Ltd.
Draft Guidance for Industry on Labeling Over-the-Counter Human Drug Products; Questions and Answers; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Labeling OTC Human Drug ProductsQuestions and Answers.'' This guidance is intended to assist manufacturers, packers, and distributors of over-the-counter (OTC) drug products to implement the agency's regulation on standardized content and format requirements for the labeling of OTC drug products. This draft guidance discusses labeling questions that have been frequently asked by manufacturers, packers, and distributors in implementing the new requirements. The labeling examples in this draft guidance show various format and content features and suggest how OTC drug monograph labeling information finalized before the new requirements can be converted to the new format.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Registration and Listing
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.
Oral Dosage Form New Animal Drugs; Levamisole Powder for Oral Solution
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 levamisole hydrochloride soluble powder to make a drench solution for oral administration to cattle and sheep which is effective against various internal parasites.
Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption
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 reporting requirements contained in existing FDA regulations governing State petitions for exemption from preemption.
Alltech, Inc.; Filing of Food Additive Petition
The Food and Drug Administration (FDA) is announcing that Alltech, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of polyurethane polymer coating in ruminant feed.
Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications
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 reporting requirements contained in existing FDA regulations governing temporary marketing permit applications.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Product Labeling; Medication Guide Requirements
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 regulations requiring the distribution of patient labeling, called Medication Guides, for certain products that pose a serious and significant public health concern requiring distribution of FDA-approved patient medication information.
National Center for Research Services; Submission for OMB Review; Comment Request
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Research Services, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. 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: Request for Generic Clearance to collect public comments on the Proposed Standards of Care Regulations covering chimpanzees in the federally supported Chimpanzee Sanctuary System. Type of Information Collection Request: New. Need and Use of Information Collection: The Chimpanzee Health Improvement, Maintenance, and Protection Act of 2000 (Public Law 106-551) requires the Secretary of the Department of Health and Human Services to develop Standards of Care Regulations for chimpanzees in the Sanctuary System. The Act further requires the Secretary to publish the proposed standards in the Federal Register to provide a 60 day period for public comment on the proposed standards. Following receipt of public comments, NCRR/NIH will consider these comments in preparing the final regulations for the sanctuary system. The public includes members of the general population, interested communities (local, regional, and national organizations), and non-profit business entities. Input from the public will allow the NCRR/NIH staff to receive critical review of the standards from different stakeholders, provide a review and analyses of the burden estimated by the government, and help assure that the proposed standards are necessary and current. Frequency of Response: One time event. Affected Public: Non-profit entities serving as a contractor to the government to operate and maintain the federally supported Chimpanzee Sanctuary System. Type of Respondents: Non-profit businesses that possess qualified staff and resources needed to develop, operate, and maintain several hundred chimpanzees. Estimated number of respondents: 1-3. Number Respondents per Response: 1-3. Average Burden Hours Per Response: 15.4. Burden Hours Requested: 186.95. Total annualized cost to respondents is estimated at $8412.75. There is no capital, operating, and/or maintenance costs to report.
Oral Dosage Form New Animal Drugs; Lincomycin Hydrochloride Soluble Powder
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 Cross Vetpharm Group Ltd. The ANADA provides for oral use of lincomycin soluble powder to make medicated drinking water for administration to swine for the treatment of swine dysentery or to broiler chickens for the control of necrotic enteritis.
Oral Dosage Form New Animal Drugs; Ivermectin Meal
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Merial, Ltd. The NADA provides for use of ivermectin meal for the control of various species of internal parasites in horses.
Submission for OMB Review; Emergency Processing; Rapid Access to Interventional Development
Under provisions of section 1320.13 of Regulations Implementing the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) is requesting approval from the Office of Management and Budget (OMB) approval of the information collection involved in the Rapid Access to Intervention Development (RAID) mechanism. Under this program NIH makes NIH resources available to requesting extramural investigators with the goal of speeding the progress of therapeutic, preventive and/or imaging agents to clinical testing. Since the number of requests from extramural investigators greatly exceeds the available resources of the NIH, the NIH needs to collect scientific background information from the extramural investigators to determine which requests are most meritorious. The instructions on the NIH Web sites identified below explain the procedures for applying. The initial RAID program was developed in 1998 with authorization by the National Cancer Institute (NCI) Board of Scientific Counselors (BSC) and the National Cancer Advisory Board (NCAB). Subsequently, the RAID type programs were expanded within NCI and adopted also by other NIH components [National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)]. However, the requirement for clearance of the information collection burden associated with the programs was not recognized. Officials in NCI believed that the support of the research facilitated by the RAID-type programs was already covered under existing OMB authorized information collections (OMB No. 0925-0001/Exp. 9/2007 and OMB NO. 0925-0002/Exp. 6/2005), which provide for regular exchanges of information between NIH program officials and the investigators, who are supported by NIH discretionary investigator- initiated research grants, to assure that NIH remains responsive to new directions in the research, progress in conducting the research and additional budgetary and scientific resources needed to successfully complete the research. As a consequence, the requirement for specific approval of the information collected in the furtherance of the Federal assistance activity was not formally recognized. At this time, NIH is requesting by emergency clearance procedures that the OMB approve the collection of information under the various existing RAID-type programs and to approve the proposed expansion of the program to accommodate new initiatives under the NIH Director's Roadmap (https://nihroadmap.nih.gov/), which will employ the RAID model to facilitate advances in research by rapid availability of needed resources. Six Raid-like programs are currently in existence; another is shortly to be announced. NCI RAID (https://dtp.nci.nih.gov/docs/raid/ raidindex.html); NCI R*A*N*D (https://dtp.nci.nih.gov/docs/rand/rand index.html); NCI-NIAID Inter-Institute Program for the Development of AIDS-Related Therapeutics (https://dtp.nci.nih.gov/docs/dart/dart/html); NCI RAPID (https://www3.cancer.gov/prevention/rapid/); NCI DECIDE (https://dtp.nci.nih.gov/docs/ddg/ddgdescript.html); NIDDKT1D-RAID (https://www.niddk.nih.gov/fund/diabetesspecailfunds/t1d-raid/ raid.htm); NIH Roadmap RAID program (https://nihroadmap.nih.gov/). The NIH has determined that the continuing collection of information is essential to the mission of the agency and the agency cannot reasonably comply with the normal clearance procedures because public harm is reasonably likely to result and the use of the normal clearance process is reasonably likely to disrupt the collection of information. NIH is requesting OMB approval by January 24, 2005, in order to be able to receive applications from scientific investigators that have been in preparation and development for many months in the expectation of support under the announced due dates of the RAID programs. Delay or deferral will create disruption of on going investigations and delay scientific advances. Proposed Collection: Title: ``Rapid Access to Interventional Development.'' The NCI RAID program receives between 30-40 applications yearly. R*A*N*D receives 8-10 applications yearly. IIP receives 10-15 applications yearly. Technology transfer information2 hours per application, completed by technology transfer specialist. Letters of commitment0.5 hours per application, completed by institutional head of clinical research. Application30-40 hours per application, completed by Ph.D., or M.D., Ph.D., level scientist. Other RAID type programs accept about 10-12 applications; however, the length of the material requested is somewhat shorter than the NCI Raid programs. The proposed NIH director's Roadmap Initiative anticipates 20-30 applications in the initial round. The total annual burden anticipated for the receipt dates for this emergency clearance request is estimated to be 4000 hours. A subsequent regular request for approval of the continuing collection will address the future estimated annual burden. The cost to the respondents based on the 4000 hour burden will be approximately $250,000. 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 on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time should be directed to the Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Mr. Joe Ellis, Division of Grants Policy, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3513, 6705 Rockledge Drive, Bethesda, MD 20892-7974, or call non-toll-free number (301) 435-0935, or e-mail your request, including your address to: ellisj@od.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Proposed Collection; Comment Request; Training Tomorrow's Scientists: Linking Minorities and Mentors Through the Web
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 Office of Behavioral and Social Sciences Research (OBSSR), 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: Training Tomorrow's Scientists: Linking Minorities and Mentors Through the Web. Type of Information Collection Request: REVISION, OMB control number 0925-0475, Expiration Date 3/31/ 3005. Need and Use of Information Collection: This Web site allows federally-funded researchers supported by any of the 27 Institutes and Centers of the NIH to submit an electronic form describing his or her research areas, as well as interests in mentoring minority students or junior faculty. The researcher's description is posted on the Web site for searching by interested minority applicants. Minority students or junior faculty search the Web site to identify researchers with whom they would like to work. The research projects in the database are located all over the country and involve cutting edge research activities by scientists funded through the Institutes and Centers of the NIH. These research projects range from studies of children to research on older adults, from laboratory research to field research, from social research to a combination of biological and behavioral research. Applicants conduct an electronic search using categories such as research areas of interest, desired geographic location of the researcher, and their level of education. The primary objective of the program is to ensure that, in the coming decades, a concentration of minority researchers will be available to address behavioral and social factors important in improving the public health and eliminating racial disparities. Increasing the number of minority scientists in the U.S. will expand our currently limited knowledge about the epidemiology and treatment of diseases in minority population. Frequency of Response: On occasion. Affected Public: Individuals or households. Type of Respondents: Students, Post-doctorals, Junior Faculty, and Principal Investigators. The annual reporting burden is as follows: Estimated Number of Respondents: 400; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 10 minutes; and Estimated Total Annual Burden Hours Requested: 148. There is no annualized cost to respondents. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report.
Standards of Care for Chimpanzees Held in the Federally Supported Chimpanzee Sanctuary System
The National Institutes of Health (NIH) proposes to issue standards to implement provisions of the Chimpanzee Health Improvement, Maintenance, and Protection Act (CHIMP Act) authorizing the Secretary of the Department of Health and Human Services (DHHS) to develop and publish standards of care for chimpanzees held in the Sanctuary system supported by Federal funds authorized under the CHIMP Act. These regulations will apply to only those facilities receiving Federal funds as a part of the federally funded chimpanzee Sanctuary system.
Privacy Act of 1974; New System of Records
In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to add a new system of records. The new system of records, ``State-Provided Physician Records for the Application Submission & Processing System, SDB, BHPr, HRSA,'' will cover health care practitioners who are the subjects of databases collected and maintained by State Primary Care Offices/Associations. Such health care practitioners include physicians (both M.D.s and D.O.s), licensed or otherwise authorized by a State to provide health care services. This system of records is required to comply with the implementation directives of the Act, Public Law 108-20. The records will be used to support the Application Submission and Processing System electronic application for the development, submission, and review of applications for HPSAs and MUPs. The most critical requirement for accurate designation determinations is accurate data on the location of primary care providers relative to the population. To this end, SDB continually tries to obtain the latest data on primary care providers and their practice location(s) at the lowest geographical level possible for use in the designation process, with the objective of minimizing the level of effort required on the part of States and communities seeking designations.
Notice of Hearing: Reconsideration of Disapproval of Indiana State Plan Amendment 02-021
This notice announces an administrative hearing to be held on January 20, 2005, at 10 a.m., 233 North Michigan Avenue, Minnesota Room, Chicago, Illinois 60601 to reconsider the decision to disapprove Indiana State Plan Amendment (SPA) 02-021. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by January 25, 2005.
Government-Owned Inventions; Availability for Licensing
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.
Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients.'' The guidance recommends content for a labeling statement for cosmetic products containing alpha hydroxy acids (AHAs) as ingredients. This action was prompted by a citizen petition filed by the Cosmetic, Toiletry, and Fragrance Association, which requested that FDA issue a regulation establishing labeling requirements relating to sun protection with use of cosmetic products containing AHAs.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Third Party Review Under the Food and Drug Administration Modernization Act
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Devices; Third Party Review Under the Food and Drug Administration Modernization Act'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern
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 reporting requirements for assessing the antimicrobial resistance concerns as part of the overall preapproval safety evaluation of new animal drugs, focusing on the effect of antimicrobial new animal drugs on bacteria of human health concern.
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration
The Food and Drug Administration (FDA) is publishing its annual comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's good guidance practices (GGPs) regulations. It is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past year.
Orally Administered Drug Products for Relief of Symptoms Associated With Overindulgence in Food and Drink for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph
The Food and Drug Administration (FDA) is proposing to amend the tentative final monograph (TFM) for over-the-counter (OTC) orally administered drug products for relief of symptoms associated with overindulgence in food and drink to include an additional use for products that contain bismuth subsalicylate as an active ingredient labeled for the relief of symptoms of upset stomach due to overindulgence resulting from food and drink. This proposal is part of FDA's ongoing review of OTC drug products.
Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Extension of Comment Period
The Food and Drug Administration (FDA) is extending to February 23, 2005, the comment period for the notice that appeared in the Federal Register of November 24, 2004 (69 FR 68384). In the notice, FDA requested comments on a draft risk assessment of the potential impact that food-animal use of streptogramin antimicrobials has on the resistance to chemically similar streptogramins used to treat human enterococcal infections. The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
International Conference on Harmonisation; Draft Guidances on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs and S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals; Availability; Reopening of Comment Periods
The Food and Drug Administration (FDA) is reopening until February 18, 2005, the comment periods for the draft guidances entitled ``E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs'' and ``S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals.'' The draft guidances were prepared under the auspices of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. FDA published notices of availability of the draft guidances in the Federal Register of September 13, 2004 (69 FR 55163 and 69 FR 55164, respectively). FDA is taking this action in response to requests to extend the comment periods for both draft guidances.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act, Third-Party Premarket Submission Review, and Quality System Inspections Under the United States/European Community Mutual Recognition Agreement
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.
Notice of SAMHSA's Ceasing Publication of Notices of Funding Availability (NOFAs) and Requests for Applications (RFAs) in the Federal Register
Consistent with the Department of Health and Human Services management objectives, the Substance Abuse and Mental Health Services Administration (SAMHSA) announces a change in its practice of publishing notices of grant funding availability in the Federal Register. Rather than continue publishing NOFAs and RFAs in the Federal Register, SAMHSA will instead post notices of funding availability only on https://www.Grants.gov and https://www.samhsa.gov. Only single source or limited competition announcements will continue to be published in the Federal Register. This change will be effective January 3, 2005. Applicants should 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 Center1-800-789-CMHS (2647)for mental health grants.
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