Department of Health and Human Services March 2009 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 317
Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 197 entitled ``Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files.'' The purpose of this draft guidance is to simplify the preparation and evaluation of submissions in support of new animal drug applications by providing a uniform system for documenting statistical analysis programs and data files.
Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop
The Food and Drug Administration (FDA) Chicago District, in cosponsorship with the Association of Food and Drug Officials (AFDO), is announcing a public workshop entitled ``Drugs and DevicesPromoting and Protecting the Public Health Through Risk Management and Product Cycle Improvement.'' This 2-day public workshop is intended to provide information about FDA drug and device regulation to the regulated industry. Date and Time: The public workshop will be held on Monday, June 8, 2009, from 10:20 a.m. to 5 p.m. and Tuesday, June 9, 2009, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Doubletree Hotel ChicagoOakbrook, 1909 Spring Rd., Oak Brook, IL 60523, 800-222-TREE, 800-222-8733, or 630-472-6000, FAX: 630-573-1909. Attendees are responsible for their own accommodations. To make reservations at the Doubletree Hotel ChicagoOakBrook, at the reduced conference rate, contact the Doubletree Hotel ChicagoOakBrook before May 5, 2009, citing meeting code ``AFDO Conference''. Contact: William Weissinger, Food and Drug Administration, 550 W. Jackson Blvd., 15th Fl., Chicago, IL 60661, 312-596-4210, FAX: 312-596- 4242, e-mail: William.weissinger@fda.hhs.gov. Registration: You are encouraged to register by May 12, 2009. The AFDO registration fees cover the cost of facilities, materials, and breaks. Seats are limited; please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 7:30 a.m. The cost of registration follows:
Notice of Public Comment Period for the NIOSH Childhood Agricultural Injury Prevention Initiative
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following document which encompasses progress to-date and planned future activities of the NIOSH Childhood Agricultural Injury Prevention Initiative. The document, NIOSH Childhood Agricultural Injury Prevention Initiative: Progress and Proposed Future Activities, can be found at https://www.cdc.gov/niosh/ review/public/145/. Public Comment Period: March 16, 2009 to May 15, 2009. Purpose: To seek comments on the progress and proposed future activities of the Childhood Agricultural Injury Prevention Initiative begun by NIOSH in October 1996, in order to ensure that the program is meeting the needs of stakeholders (e.g., national youth agricultural injury prevention organizations, agricultural youth injury prevention groups, individuals, etc.) and other interested members of the public, and to identify ways in which the program can be improved to increase its impact on the safety of children in agriculture. A review of progress and public comment on the proposed future activities of the NIOSH Childhood Agricultural injury Prevention Initiative is desired periodically to assess whether the NIOSH Childhood Agricultural Injury Prevention Initiative is addressing the most pressing issues and areas of childhood agricultural injury prevention. NIOSH will compile and consider all comments received through the NIOSH docket and use them in making decisions on how to proceed with the Childhood Agricultural Injury Prevention Initiative. Background: The problem of children being injured while living, working, or visiting agricultural work environments (farms) has been recognized for several decades. The most recent data suggest about 100 youths under the age of 20 die on farms each year and about 27,600 farm-related injuries occur to the same age group. Many individuals and groups have advocated for the prevention of agricultural injuries experienced by youths, and media attention has been generated on the issue, but until 1996 a national coordinated effort to address the problem had not existed. In April 1996, the National Committee for Childhood Agricultural Injury Prevention (NCCAIP) published a report entitled Children and Agriculture: Opportunities for Safety and Health, A National Action Plan to promote the health and safety of children exposed to agricultural hazards. The National Action Plan recommends leadership, surveillance, research, education, and public policy. The plan specifically recommended that NIOSH serve as the lead federal agency in preventing childhood agricultural injury. Due in large part to the efforts by NCCAIP to raise awareness and concern about childhood agricultural injury issues, in October 1996, NIOSH began implementing a Childhood Agricultural Injury Prevention Initiative. In July, 1999, a review was conducted by NIOSH to seek input on the progress and direction of the Childhood Agricultural Injury Prevention Initiative to date. The input provided by stakeholders at that meeting was useful in providing insight into stakeholder needs and in helping to improve the Childhood Agricultural Injury Prevention Initiative. In 2001, a Childhood Agricultural Injury Prevention Summit was organized and convened by the National Children's Center for Rural and Agricultural Health and Safety (NCCRAHS), an extramurally funded component, five years after the implementation of the NIOSH Childhood Agricultural Injury Prevention Initiative. The goal of the summit was to conduct a five-year review of the 1996 National Action Plan and to use a consensus development process to generate strategies for the future. Specifically, participants were asked to consider: (a) Successes to date, (b) gaps and barriers in achieving objectives, (c) current and potential effective interventions not addressed in the National Action Plan, and (d) strategies for the future. To date, NIOSH has undertaken a number of activities, both intramurally and extramurally, to address the recommendations in the 1996 National Action Plan and the 2001 Childhood Agricultural Injury Prevention Summit. Status: The Document, NIOSH Childhood Agricultural Injury Prevention Initiative: Progress and Proposed Future Activities, will be available for comment by stakeholders and other interested members of the public. Written comments should be submitted to the NIOSH Docket Office as outlined in the next section. Docket: Written comments on the usefulness of the Childhood Agricultural Injury Prevention Initiative for improving childhood agricultural safety and suggestions for enhancing or improving the impact of the Initiative should be mailed to the NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone (513) 533-8303, facsimile (513) 533-8285. Comments may also be submitted by e-mail to niocindocket@cdc.gov. E- mail attachments should be formatted in Microsoft Word. All materials submitted to the Agency should reference NIOSH docket number 145 and must be submitted by May 15, 2009 to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226. After the comment period has closed, comments may be accessed electronically at https:// www.cdc.gov/niosh under the link to the NIOSH docket. As appropriate, NIOSH will post comments with the commenters' names, affiliations, and other information, on the Internet. Contact Person for Technical Information: David Hard, Health Scientist, Analysis and Field Investigations Branch, Division of Safety Research, telephone (304) 285-6068, E-mail DHard@cdc.gov, facsimile (304) 285-6235.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Improving Patient Flow and Reducing Emergency Department Crowding.'' 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. This proposed information collection was previously published in the Federal Register on January 15th, 2009 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.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. app. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2
The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of vitamin D2 as a nutrient supplement in soy-based food products. This action is in response to a petition filed by Dean Foods Co. (Dean Foods).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Shortages Data Collection System (formerly “Emergency Medical Device Shortages Program Survey”)
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 and Food and Drug Administration; User Fees and Refunds for Premarket Approval Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``User Fees and Refunds for Premarket Approval Applications'' (PMAs). The purpose of this draft guidance document is to outline the types of PMAs subject to user fees, including supplements and other submissions, as well as those that do not have an associated user fee. The draft guidance also identifies industry and FDA actions on these submissions that may result in a refund of the fee.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products
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.
Public Consultation on Personnel Reliability Issues
The National Science Advisory Board for Biosecurity (NSABB), an advisory committee of the Federal Government, is hosting a public consultation to engage the scientific community and general public in a discussion of personnel reliability, with a focus on optimal characteristics of individuals with access to Select Agents. This public consultation is an opportunity for members of the scientific community and general public to provide input on these important issues.
Submission for OMB Review; Comment Request; Women's Health Initiative Observational Study
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director, 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 of the information collection listed below. This proposed information collection was previously published in the Federal Register on December 30, 2008, page 79889- 79890 and allowed 60-days for public comment. One comment was received and appropriate response was made. 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 current valid OMB control number. Proposed Collection: Title: Women's Health Initiative (WHI) Observational Study. Type of Information Collection Request: REVISION: OMB No. 0925-0414, Expiration date: 05/31/2009. Need and Use of Information Collection: This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up years for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women. Frequency of Response: Annually. Affected Public: Individuals and physicians. Type of Respondents: Women, next-of-kin, and physician's office staff. The annual reporting burden is as follows:
Request for Public Comment Concerning Requirements for Transferring Children From the Placement and Care Responsibility of a State Title IV-E Agency to a Tribal Title IV-E Agency and Tribal Share of Title IV-E Administration and Training Expenditures
Effective October 1, 2009, Public Law 110-351 provides Indian Tribes with the option to operate a foster care, adoption assistance and, at Tribal option, a kinship guardianship assistance program under title IV-E of the Social Security Act (the Act). The Federal government would share in the costs of Tribes operating an ACF-approved title IV-E program. Public Law 110-351 requires that ACF develop interim final rules after consulting with Tribes and affected States on the implementation of the Tribal plan requirements in section 479B of the Act and other amendments made by the Tribal provisions in section 301 of Public Law 110-351. The law requires that such regulations include: (1) Procedures to ensure that a transfer of State responsibility for the placement and care of a child under a State title IV-E plan to a Tribal title IV-E plan occurs in a manner that does not affect the child's eligibility for title IV-E or title XIX Medicaid and such services or payments; and, (2) the in-kind expenditures from third- party sources permitted for the Tribal share of administration and training expenditures under title IV-E. This notice is designed to provide a written opportunity for comment to all interested persons, and specifically the affected States and to notify Tribal leaders of in-person opportunities to consult with the Children's Bureau on the development of these regulations.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug Experience Reporting
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.
Memorandum of Understanding With Baylor College of Medicine, The University of Texas M.D. Anderson Cancer Center, Rice University, University of Houston, The University of Texas Health Science Center at Houston, Texas A&M Health Science Center, The University of Texas Medical Branch at Galveston, and The Methodist Hospital Research Institute for the FDA-ANH Nanotechnology Initiative
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) with The Alliance for NanoHealth (ANH), a collaboration among: Baylor College of Medicine, The University of Texas M.D. Anderson Cancer Center, Rice University, University of Houston, The University of Texas Health Science Center at Houston, Texas A&M Health Science Center, The University of Texas Medical Branch at Galveston, and The Methodist Hospital Research Institute. This MOU identifies the terms of collaboration between FDA and ANH in the area of nanotechnology. Specifically, this MOU establishes the FDA-ANH Nanotechnology Initiative (FANTI), a public- private partnership dedicated to the identification of scientific and translational gaps in moving nanoengineered medical products from the preclinical stages of development through clinical stages and then to commercialization, all with immediate benefit to public health. The activities are aligned with the mutual interests and respective missions of the Parties, including the FDA's Critical Path Initiative which seeks to modernize the product development and regulatory sciences needed to reduce uncertainties about product performance throughout the product life cycle. Thus, a key goal for the Parties is to improve the safety and efficacy of nanoengineered products and speed their delivery to the patients who need them and the consumers who use them.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-May 6, 2009
This notice announces that a public meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, May 6, 2009. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. The Committee may also review and evaluate medical literature and make recommendations concerning items and services that may be eligible for Medicare coverage. This meeting will focus on the requirements for evidence to determine if the use of screening genetic testing of beneficiaries without signs or symptoms of disease improves health outcomes in Medicare beneficiaries. The meeting will discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
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.
State Median Income Estimate for a Four-Person Family: Notice of the Federal Fiscal Year (FFY) 2010 State Median Income Estimates for Use Under the Low Income Home Energy Assistance Program (LIHEAP) (Catalog of Federal Domestic Assistance Number 93.568) Administered by the U.S. Department of Health and Human Services (HHS), Administration for Children and Families, Office of Community Services, Division of Energy Assistance
This notice announces to LIHEAP grantees the estimated median income of four-person families in each State and the District of Columbia for FFY 2010 (October 1, 2009, to September 30, 2010). LIHEAP grantees that choose to base their income eligibility criteria on these State median income estimates may adopt these estimates (up to 60 percent) on the estimates' date of publication in the Federal Register or on a later date as discussed below. This enables these grantees to implement this notice during the period between the heating and cooling seasons. However, by October 1, 2009, or the beginning of the grantees' fiscal years, whichever is later, these grantees must adjust their income eligibility criteria so that such criteria are in accord with the FFY 2010 State median income estimates. This listing of 60 percent of estimated State median incomes provides one of the maximum income criteria that LIHEAP grantees may use in determining a household's income eligibility for LIHEAP.
Office of the National Coordinator for Health Information Technology; HIT Standards Committee and HIT Policy Committee Nomination Letters
The American Recovery and Reinvestment Act of 2009 (Act), Public Law 111-5 amends the Public Health Service Act (PHSA) to add new sections 3002 and 3003. The new section 3003 of the PHSA establishes the HIT Standards Committee to make recommendations to the National Coordinator for Health Information Technology on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of health information technology adoption. The HIT Standards Committee members are to be appointed by the Secretary of the Department of Health and Human Services with the National Coordinator taking a leading role. Membership of the HIT Standards Committee should at least reflect the following categories of stakeholders and will include other individuals: providers, ancillary healthcare workers, consumers, purchasers, health plans, technology vendors, researchers, relevant Federal agencies, and individuals with technical expertise on health care quality, privacy and security, and on the electronic exchange and use of health information. In addition, we also seek nominations to the HIT Policy Committee (established by the new section 3002 of the PHSA), which makes recommendations to the National Coordinator on the implementation of a nationwide health information technology infrastructure. The HIT Policy Committee will consist of at least 20 members. Three of these members will be appointed by the Secretary of the Department of Health and Human Services. Of the three members, one must be a representative of the Department of Health and Human Services and one must be a public health official. If, 45 days after the enactment of the Act, an official authorized under the Act to make appointments to the HIT Policy Committee has failed to make an appointment(s), the Act authorizes the Secretary of HHS to make such appointments. The Department of Health and Human Services is consequently accepting nominations for the HIT Policy Committee. New section 3008 of the PHSA allows the Secretary to recognize the NeHC (if modified to be consistent with the requirements of section 3002 and 3003 of the Act and other federal laws) as either the HIT Policy Committee or the HIT Standards Committee. At this time, the Department of Health and Human Services is evaluating options regarding the National eHealth Collaborative and its role in relation to those Committees. For appointments to either the HIT Standards Committee or the HIT Policy Committee, I am announcing the following: Letters of nomination and resumes should be submitted by March 16, 2009 to ensure adequate opportunity for review and consideration of nominees prior to appointment of members.
Determination of Regulatory Review Period for Purposes of Patent Extension; PROFENDER
The Food and Drug Administration (FDA) has determined the regulatory review period for PROFENDER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.
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