Department of Health and Human Services December 2008 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 231
New Animal Drugs; Tylosin
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 Elanco Animal Health. The supplemental NADAs provide for use of tylosin tartrate soluble powder in drinking water of swine followed by tylosin phosphate in medicated swine feed for the treatment and control of swine dysentery and the control of porcine proliferative enteropathies.
State Long-Term Care Partnership Program: Reporting Requirements for Insurers
This final rule sets forth reporting requirements for private insurers that issue qualified long-term care insurance policies in States participating in the State Long-Term Care Partnership Program established under the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109- 171). Section 6021 of the DRA requires that the Secretary of Health and Human Services (the Secretary) specify a set of reporting requirements and collect data from insurers on qualified long-term care insurance policies issued under the program and the subsequent use of the benefits under these policies. Under a State Long-Term Care Partnership Program, an amount equal to the benefits received under the long-term care insurance policy is disregarded in determining the assets of an individual for purposes of Medicaid eligibility and estate recovery.
Office of the Assistant Secretary for Planning and Evaluation; Privacy Act of 1974; Report of New System of Records
In accordance with the requirements of the Privacy Act of 1974, the Office of Assistant Secretary for Planning and Evaluation (ASPE) is proposing to establish a new system of records, called the Partnership for Long Term Care Data Set. The Partnership allows states to offer special Medicaid asset disregards to persons purchasing specially certified long term care insurance policies. This program and the data collection were established by the Deficit Reduction Act of 2005Section 6021. Although the Privacy Act requires only that the ``routine uses'' portion of the system be published for comment, ASPE invites comments on all portions of this notice. Elsewhere in today's Federal Register, a related final rulemaking establishing the State Long Term Care Partnership: Reporting Requirements for Insurers.
Solicitation of New Safe Harbors and Special Fraud Alerts
In accordance with section 205 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Draft Guidance for Industry on Anesthetics for Companion Animals; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 192 entitled ``Anesthetics for Companion Animals.'' This guidance makes recommendations for the development of anesthetic new animal drug products for companion animals. The guidance discusses the contents of the target animal safety, effectiveness, and labeling technical sections of a new animal drug application (NADA) for general anesthetics.
Memorandum of Understanding Between the Office of the Assistant Secretary of Defense (Health Affairs), the Veterans Health Administration, and the U.S. Food and Drug Administration
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Office of the Assistant Secretary of Defense (Health Affairs), the Veterans Health Administration, and the U.S. Food and Drug Administration. The purpose of the MOU is to enhance knowledge and efficiency by providing for the sharing of information and expertise between the Federal partners. The goals of the collaboration are to explore ways to: Further enhance information sharing efforts through more efficient and robust interagency activities; promote efficient utilization of tools and expertise for product risk identification, validation and analysis; and build infrastructure and processes that meet the common needs for evaluating the safety, efficacy, and utilization of drugs, biologics, and medical devices, as well as the safety and utilization of foods. The MOU is available on FDA's Web site at www.fda.gov/oc/mous/domestic/ domesticmous.htm.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
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; Export of Food and Drug Administration Regulated Products: Export Certificates
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 information collection requirements imposed on firms that intend to export to countries that require an export certificate as a condition of entry for FDA regulated products, pharmaceuticals, biologics, and devices as indicated in the Federal Food, Drug, and Cosmetic Act (the act) as amended.
Submission for OMB Review; Comment Request; The Effectiveness of the NIH Curriculum Supplements Programs and Career Resources
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 was previously published in the Federal Register on September 23, 2008 (Volume 73, Number 185, page 54840) and allowed 60-days for public comment. One comment was received. 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 Programs and Career Resources. Information Collection Request: Reinstatement. Need and Use of Information Collection: The survey will attempt to assess customer demographics and their satisfaction with the NIH curriculum supplements in presenting science in a more engaging and interactive way. The supplements help K-12 educators teach science by featuring the latest NIH research and utilized research-based instructional methods. 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 6,000 teachers have attended an OSE workshop. OSE also develops a series of videos, Women Are Scientists, that aim to excite middle school students on careers in the health sciences. Assessing the effectiveness of the NIH curriculum supplements, teacher workshops, and career resources is critical to determining if OSE is successfully fulfilling its mission. OSE has the database infrastructure in place to easily collect data from supplement and career video requesters and workshop attendees. At present, we do not have clearance to contact our customers to determine how NIH resources are meeting their educational needs.
Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The draft guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during the Federal Government Response Stages of an influenza pandemic. The agency makes recommendations to industry for focusing limited resources on reports related to influenza-related products and other specific types of reports indicated in the draft guidance.
Microbiological Testing for Contact Lens Care Products; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Microbiological Testing for Contact Lens Care Products.'' FDA is co-sponsoring the public workshop with the American Academy of Ophthalmology, the American Academy of Optometry, the American Optometric Association, and the Contact Lens Association of Ophthalmologists. The purpose of the public workshop is to discuss test method parameters for evaluating the activity of contact lens care products against Acanthamoeba and to discuss elements of microbiological test methods that simulate ``real world'' consumer use conditions. Date and Time: The public workshop will be held on January 22 and 23, 2009, from 8 a.m. to 5 p.m. Participants are encouraged to arrive by 7:30 a.m. to allow enough time for parking and security screening. Security Screening will begin at 7 a.m. Location: The public workshop will be held at the Food and Drug Administration, White Oak Conference Center, 10903 New Hampshire Ave., Bldg. 2 (Central Shared Use Building), Silver Spring, MD. Attendees should follow the directions provided in the Registration Information section of this document. Contact: Daryl L. Kaufman, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4200, FAX: 240-276-4234, e-mail: Daryl.Kaufman@fda.hhs.gov, or Marc Robboy, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4200, FAX: 240-276-4234, e-mail: Marc.Robboy@fda.hhs.gov. Agenda: The purpose of the conference is to discuss test methods for evaluating the anti-microbial activity of contact lens care products. On January 22, 2008, we hope to reach consensus on critical test method parameters for evaluating the activity of contact lens care products against Acanthamoeba. These parameters include organism species and strain, trophozoite culture and cyst production, microbial challenge level, and assay method for survivors. On January 23, 2008, we hope to present and discuss critical elements for new or modified disinfection efficacy test methods that simulate ``real world'' consumer use conditions. These elements include contact lens and lens case uptake of preservative and other solution ingredients, solution evaporation, minimal consumer compliance, biofilm formation and clinical isolates as challenge organisms. Background information on the public workshop, registration information, the agenda, information about lodging, and other relevant information will be posted on the Internet at www.jcahpo.org/clmw. Registration Information: Registration must be completed online at www.jcahpo.org/clmw. Please pre-register no later than January 8, 2009 (see instructions in this paragraph). There will be no onsite registration. Non-U.S. citizens are subject to additional security screening and should pre-register at least 3 weeks in advance. There is a registration fee of $250 for this workshop. Early registration is recommended because seating is limited. If you need special accommodations due to a disability, please contact Ms. Janice Prestwood at 800-284-3937, ext. 229 (toll free), 651-731-7229 (direct) or 651-731-0410 (fax) at least 7 days before the public workshop. Lodging, travel, and security clearance information are also available from the registration Web site. Persons without Internet access may contact Ms. Janice Prestwood for help in completing the registration form.
Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendation for Vancomycin HCl.'' The recommendation provides specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for vancomycin HCl capsules.
Draft Guidance for Industry on Changes to Approved New Animal Drug Applications-New Animal Drug Applications Versus Category II Supplemental New Animal Drug Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 191 entitled ``Changes to Approved NADAsNew NADAs vs. Category II Supplemental NADAs''. This guidance is intended to assist sponsors who wish to apply for approval of changes to approved new animal drugs that require FDA to reevaluate safety and/or effectiveness data. The goal of this guidance is to create greater consistency in how such applications are handled by sponsors and by FDA's Center for Veterinary Medicine (CVM).
Guidance for Industry on Orally Disintegrating Tablets; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Orally Disintegrating Tablets.'' The guidance provides pharmaceutical manufacturers of new and generic products with an agency perspective on the definition of an orally disintegrating tablet (ODT) and also provides recommendations to applicants who would like to designate proposed products as ODTs.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Cosmetic Registration Program
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.
Advisory Committees; Filing of Closed Meeting Reports
The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2008.
Draft Guidance for Industry on Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches.'' This draft guidance is intended to inform pharmaceutical manufacturers of the agency's thinking regarding genotoxic and carcinogenic impurities in drug substances and drug products, including biologic products that are regulated by the Center for Drug Evaluation and Research (CDER), and to provide recommendations on how to evaluate the safety of these impurities during clinical development and for marketing applications. This draft guidance, when finalized, will clarify FDA's additional testing and exposure threshold recommendations for situations in which genotoxic or carcinogenic impurities are present. This draft guidance addresses synthetic impurities and degradants in drug substances, but does not otherwise address the genotoxicity or carcinogenicity of actual drug substances or intended drug product ingredients. This draft guidance also applies to known starting materials or anticipated reaction products.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices
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; Postmarketing Adverse Drug Experience Reporting
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 postmarketing adverse drug experience reporting and recordkeeping requirements.
Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Request for Nominations
The Health Resources and Services Administration (HRSA) is requesting nominations to fill four upcoming vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL).
Seeking To Evaluate Commercial Products, or Products in Development, for In Vitro Serological Diagnosis of Pertussis
The Centers for Disease Control and Prevention (CDC), National Center for Immunization and Respiratory Diseases (NCIRD), Division of Bacterial Diseases (DBD) through its component Branches have lead technical responsibility for research, development and evaluation of diagnostic tools for pertussis and application of these to epidemiologic studies of pertussis. CDC uses epidemiologic, laboratory, clinical, and biostatistical sciences to control and prevent vaccine preventable infectious diseases. CDC also conducts applied research in a variety of settings, and translates the findings of this research into public health practice. CDC is seeking to evaluate commercial products, or products in development, for in vitro serological diagnosis of pertussis. Specifically these should include tests to detect anti-pertussis toxin antibodies in infected and vaccinated individuals. The tests should be based on standardized reagents commonly used in the field (such as FDA Reference Serum Standard Lot 3 or equivalents). Products will be evaluated in CDC and collaborating laboratories and if appropriate, may be used in epidemiologic validation studies. Data obtained from this comparative analysis may be used by CDC in making recommendations and decisions for diagnosis of pertussis in the public health setting. Interested organizations that may have candidate products are invited to submit documentation for CDC to assess whether the offered product(s) are at a sufficient stage of development to be included in this comparative analysis. As a minimum, submitted information should be sufficient for CDC to determine the following for each candidate product: a. Product package insert or detailed instructions for use b. Detailed information to determine if the product is calibrated to a recognized standard c. Preliminary data demonstrating suitability for validation studies Organizations that have products selected by CDC for this comparative analysis will be required to enter into an appropriate agreement prior to the transfer of any material to CDC. Sample agreements may be viewed at the following Web site: https://www.cdc.gov/ od/ads/techtran/forms.htm. All information submitted to CDC will be kept confidential as allowed by relevant federal law, including the Freedom of Information Act (5 U.S.C. 552) and the Trade Secrets Act (18 U.S.C. 1905). Only information submitted within thirty days of publication of this notice will be reviewed to determine if the offered product(s) will be acceptable for possible inclusion in this comparative analysis. Responses are preferred in electronic format and can be e-mailed to the attention of Jacqueline Goolsby jgoolsby@cdc.gov. Mailed responses can be sent to the following address: Jackie Goolsby, Branch Manager, Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases, Division of Bacterial Diseases, 404-639-1319 (Phone), 404-639-3059 (Fax), 1600 Clifton Rd. NE., Mail Stop C-09, Atlanta, GA 30333.
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of the Impact of Coupons Embedded in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Perceptions of Product Risks and Benefits
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a study of the impact of the presence of coupons offering price incentives or rebates on consumers' perceptions of product risks and benefits in direct-to-consumer (DTC) print ads.\1\ Notice of proposed information collection for this project was previously published on February 6, 2006 (71 FR 6077) and withdrawn. This revised notice replaces the previous notice.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Implementation of Sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007
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.
Submission for OMB Review; Comment Request; The Hispanic Community Health Study (HCHS)/Study of Latinos (SOL)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), 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. This proposed information collection was previously published in the Federal Register on October 3, 2008, page 57634, and allowed 60 days for public comment. One comment was 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: Hispanic Community Health Study (HCHS)/ Study of Latinos (SOL). Type of Information Collection Request: New Collection. Need and Use of Information Collection: The Hispanic Community Health Study (HCHS)/ Study of Latinos (SOL) will identify risk factors for cardiovascular and lung disease in Hispanic populations and determine the role of acculturation in the prevalence and development of these diseases. Hispanics, now the largest minority population in the US, are influenced by factors associated with immigration from different cultural settings and environments, including changes in diet, activity, community support, working conditions, and health care access. This project is a multicenter, six- and-a-half year epidemiologic study and will recruit 16,000 Hispanic men and women aged 18-74 in four community-based cohorts in Chicago, Miami, San Diego, and the Bronx. The study will examine measures of obesity, physical activity, nutritional habits, diabetes, lung and sleep function, cognitive function, hearing, and dental conditions. Closely integrated with the research component will be a community and professional education component, with the goals of bringing the research results back to the community, improving recognition and control of risk factors, and attracting and training Hispanic researchers in epidemiology and population-based research. Frequency of Response: The participants will be contacted annually. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 30,401; Estimated Number of Responses per Respondent: 2.234; Average Burden Hours Per Response: 0.7178; and Estimated Total Annual Burden Hours Requested: 48,755. The annualized cost to respondents is estimated at $756,412, assuming respondents time at the rate of $15 per hour and physician time at the rate of $55 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Draft Guidance for Industry and Food and Drug Administration Staff; Submission and Review of Sterility Information in Premarket Notification Submissions for Devices Labeled as Sterile; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.'' This draft guidance document updates and clarifies the procedures for reviewing premarket notification submissions (510(k)s) for devices labeled as sterile, particularly with respect to sterilization technologies FDA considers novel, and the information that should be included in 510(k)s for devices labeled as sterile.
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Connecticut Aircraft Nuclear Engine Laboratory in Middletown, Connecticut, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 24, 2008, the Secretary of HHS designated the following class of employees as an addition to the SEC: All employees of the Department of Energy (DOE), its predecessor agencies, and DOE contractors or subcontractors who worked at the Connecticut Aircraft Nuclear Engine Laboratory in Middletown, CT, from January 1, 1958 through December 31, 1965 for a number of work days aggregating at least 250 work days occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort. This designation will become effective on November 23, 2008, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the Federal Register reporting the addition of this class to the SEC or the result of any provision by Congress regarding the decision by HHS to add the class to the SEC.
Withdrawal of Certain Proposed Rules and Other Proposed Actions
The Food and Drug Administration (FDA) is announcing the withdrawal of a certain advance notice of proposed rulemaking (ANPRM) and proposed rules (NPRMs) that published in the Federal Register more than 5 years ago. These proposals are no longer considered viable candidates for final action at this time.
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