Department of Health and Human Services 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions.'' The guidance explains FDA's current thinking on a number of microbiological issues unique to the preparation of premarket submissions for antimicrobial food additives.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) has determined the regulatory review period for ERAXIS 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 human drug product.

The Food and Drug Administration (FDA) is amending its regulations to implement a nomenclature change and to ensure accuracy and clarity in the agency's regulations.

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.

The uniform protocol for the analysis of nicotine, total moisture, and pH in smokeless tobacco products, originally published in the Federal Register in 1999 (64 FR 14086), ``Notice Regarding Requirement for Annual Submission of the Quantity of Nicotine Contained in Smokeless Tobacco Products Manufactured, Imported, or Packaged in the United States,'' and revised in the Federal Register on March 14, 2008 (73 FR 13903), implements the requirement of the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA) of 1986 (15 U.S.C. 4401 et seq., Pub. L. 99-252) that each entity manufacturing, packaging, or importing smokeless tobacco products shall annually provide the Secretary of Health and Human Services (HHS) with a specification of the quantity of nicotine contained in each smokeless tobacco product. CDC is re-publishing the notice published in the Federal Register on March 14, 2008 (73 FR 13903) concerning the revision of the protocol for analysis of nicotine in smokeless tobacco products (hereinafter referred to as ``Protocol'') to (1) make a technical change to correct the date when the first report of information under the revised Protocol is due; (2) solicit public comments concerning a change in the Protocol that increased the volume of water in the pH determination from 10 mL to 20 mL, and (3) solicit public comments concerning the addition of the following commercial smokeless tobacco product categories: Dry snuff portion packs, snus, snus portion packs, and pellet or compressed. The Protocol as published in the Federal Register on March 14, 2008 (73 FR 13903), remains in effect with the technical correction to the date described below. Technical change: The language in the March 14, 2008 notice stated that ``The first report of information is due June 30, 2008, with subsequent submissions due by March 31 of each year.'' The first report date of information should be 2009 so that the sentence correctly reads: ``The first report of information is due June 30, 2009, with subsequent submissions due by March 31 of each year.''

In accordance with the National Environmental Policy Act, 42 U.S.C. 4321-4347, the NIH is issuing this notice to advise the public that an environmental impact statement will be prepared for the transport of laboratory personnel exposed to infectious agents from Fort Detrick, Frederick, Maryland to the National Institutes of Health Clinical Center, Bethesda, Maryland.

The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 6A3958) proposing that the food additive regulations be amended to provide for the safe use of alitame as a sweetening agent or flavoring in food.

This notice announces the 26th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the 28th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

The U.S. Department of Health and Human Services (HHS) (a) announces the availability of the Physical Activity Guidelines Advisory Committee Report, 2008; and (b) solicits written comments on the Report. The Physical Activity Guidelines Advisory Committee was charged with reviewing existing scientific literature to identify where there was sufficient evidence to develop a comprehensive set of specific physical activity recommendations. The report to the Secretary of HHS documents the scientific background and rationale for the issuance of physical activity guidelines. The report also identifies areas where further scientific research is needed. The Committee's evaluation of the science will be utilized by the Department to prepare the Physical Activity Guidelines for Americans. The intent is to issue physical activity guidelines for all Americans that will be tailored as necessary for specific subgroups of the population.

The Food and Drug Administration (FDA) is amending certain medical device regulations to correct typographical errors and to ensure accuracy and clarity in the agency's regulations.

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.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the opportunity for manufacturers and stakeholders to provide NIOSH with input on the potential modification of the NIOSH Statement of Standard for a Chemical, Biological, Radiological, and Nuclear (CBRN) Full Facepiece Air-Purifying Respirator (APR), which would permit an alternative to the single standard 40-mm screw mounted canister for the Department of Defense. Authority: Occupational Safety and Health Act, 29 U.S.C. 651 et seq. Public Comment Period: Submit input to the NIOSH Docket Office within 120 days from June 18, 2008. Status: Written comments may be submitted to the NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, M/S C 34, CBRN APR Mechanical Connector Design, Cincinnati, Ohio 45226, telephone (513) 533-8303, Facsimile (513) 533-8285. All material submitted should reference NIOSH Docket number 139. Comments may be e-mailed to nioshdocket@cdc.gov. All electronic comments should be formatted as Microsoft Word. All information received in response to this notice will be available for public examination and copies available at the NIOSH Docket Office, Room 111, 4674 Colombia Parkway, Cincinnati, Ohio 45226. Background: The National Personal Protective Technology Laboratory (NPPTL) is currently seeking stakeholder input regarding a request from the Department of Defense (DoD). The request is for a proposed modification to the CBRN APR Statement of Standard to allow for mechanical connectors other than the specified single 40-mm thread connector. The DoD is seeking modification of the standard to allow DoD first responders to use a newly developed respirator, the Joint Service General Protective Mask (JSGPM), for respiratory protection on military installations in the United States, or when called upon to support civil authorities. The JSGPM uses a bayonet mounted, dual filter design instead of the single standard 40-mm screw mounted canister. DoD's request is to supplement the existing NIOSH standard with an alternate design for DoD application. The DoD request to NIOSH for modification of the NIOSH Statement of Standard may be obtained from the NIOSH Docket Office using the contact information available above. Because of their experiences in responding to the terrorist events of 2001, emergency responders identified the need for the interoperability of canisters and facepieces as a respirator user issue that NIOSH needed to address. During the evolution of the CBRN Statement of Standard, NIOSH identified a single mechanical connector design requirement to support interchangeability of CBRN certified canisters and masks. The user community strongly encouraged requiring interoperable capability at all three public meetings held that discussed the requirements for the CBRN APR, and interoperability was strongly recommended in the 2002 Rand Report entitled, ``Protecting Emergency Responders Lessons Learned from Terrorist Attacks.'' Through a collaborative approach with multiple partnerships, applicable military and industrial technologies were integrated by NIOSH in the CBRN APR standard to provide the full range of protection needed by emergency responders. Working with the partnerships from Federal government agencies, the private sector, and user groups, NIOSH expedited development and publication of new testing and certification standards for voluntary use by emergency responders in CBRN terrorist attacks. Information about the public meetings that discussed the conceptual requirements for the CBRN APR is available through this link: https://www.cdc.gov/niosh/npptl/ standardsdev/cbrn/meetings.html. The NIOSH Statement of Standard and supporting concept papers for the CBRN APR are available through this link: https://www.cdc.gov/niosh/ npptl/standardsdev/cbrn/apr/. Since the Standard was established in 2003, multiple models of CBRN APRs from multiple manufacturers have been certified to the Statement of Standard. The DoD's request is to supplement the existing NIOSH standard with an alternate permissible design for DoD applications. DoD requirements for the JSGPM require availability of replacement filters in the mask carrier worn on the individual and field level logistic support for additional filters. Neither of these are requirements for commercial mask applications. For the DoD user, the advantages of the bayonet attachment on the JSGPM does not compromise the interoperability considerations for emergency responders outside of the DoD. DoD Instruction 6055.1 indicates that in non-military unique workplaces where OSHA standards or other Federal safety standards apply but do not cover, or only partially cover, existing conditions, the DoD Components shall use appropriate national safety and occupational health consensus standards under Public Law 104-113. When there is no relevant OSHA or national consensus standard, the DoD Components may develop other protective measures to ensure the safety and health of DoD personnel. Also, the DoD Components may prescribe more stringent exposure limits or monitoring frequencies than those in the basic OSHA standards. Requesting NIOSH to include another mechanical connector design for DoD applications that may allow for NIOSH certification of the JSGPM meets this intent. Through this announcement, NIOSH/NPPTL is seeking input from stakeholders and manufacturers to determine the following: 1. Opinions on the current design requirement for the single 40-mm thread canister mechanical connector. 2. Rationale and data to maintain the current design requirement. 3. Rationale and data to support adding an alternative design for DoD applications for canister mechanical connectors. 4. Identification of alternative approaches to implement the alternative design concept for the canister mechanical connector. 5. Other comments on the subject. Contact Person for Technical Information: Jonathan V. Szalajda, General Engineer, National Personal Protective Technology Laboratory (NPPTL), NIOSH, CDC, telephone (412) 386-6627, E-mail zfx1@cdc.gov.

The National Center for Complementary and Alternative Medicine (NCCAM) will convene a workshop on Meditation for Health Purposes. The goals of the workshop are to assess current knowledge and identify opportunities for future research on the mechanisms and efficacy of meditation practices for a variety of health concerns. This workshop will bring together experts in the fields of meditation practices, research design and methodology, physiological mechanisms, and affective and cognitive processes and outcomes. The meeting will draw on this expertise to elucidate relevant aspects that would best move the field of meditation research forward. The meeting will utilize a combination of short presentations, discussions, and breakout groups. The Workshop will take place on July 8-9, 2008 in Bethesda, Maryland. Seating will be limited, and researchers in the relevant scientific fields are particularly encouraged to attend. Attendees should register by July 1, 2008 by visiting https://nccam.nih.gov/news/ upcomingmeetings/. Background: The National Center for Complementary and Alternative Medicine (NCCAM) was established in 1999 with the mission of exploring complementary and alternative healing practices in the context of rigorous science, training CAM researchers, and disseminating authoritative information to the public and professionals. NCCAM funds research grants that explore the science of CAM. For more information, see https://nccam.nih.gov/research/nccamfunds.htm.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Patent No. 6,890,917, issued May 10, 2005, entitled ``Geldanamycin Derivative and Method of Treating Cancer Using Same'' [E-050-2000/0-US- 15] and foreign equivalents, to Avira Therapeutics, LLC, having a place of business in Menlo Park, California. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of the manufacture, use, distribution and sale of 17-DMAG, an analog of geldanamycin, as a therapeutic to inhibit the influenza virus, respiratory syncytial virus (RSV) and dengue virus. This replaces a notice published in 73 FR 31702 on Tuesday, June 3, 2008, which omitted the name of the potential licensee.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for Los Alamos National Laboratory, Los Alamos, New Mexico, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Los Alamos National Laboratory. Location: Los Alamos, New Mexico. Job Titles and/or Job Duties: All service support workers (which includes, but is not limited to, security guards, firefighters, laborers, custodians, carpenters, plumbers, electricians, pipefitters, sheet metal workers, ironworkers, welders, maintenance workers, truck drivers, delivery persons, radiation technicians, and area work coordinators) who worked in any operational Technical Areas with a history of radioactive material use. Period of Employment: January 1, 1976 through December 31, 2005.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides for revision of an effectiveness claim and pathogen nomenclature for a tylosin phosphate and sulfamethazine Type A medicated article used to manufacture medicated swine feeds.

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.

The Health Resources and Services Administration (HRSA) announces that the listing of entities, and their Health Professional Shortage Area (HPSA) scores, that will receive priority for the assignment of National Health Service Corps (NHSC) personnel (Corps Personnel, Corps members) for the period July 1, 2008, through June 30, 2009, is posted on the NHSC Web site at https://nhsc.bhpr.hrsa.gov/jobs/ index.asp. This list specifies which entities are eligible to receive assignment of Corps members who are participating in the NHSC Scholarship Program, the NHSC Loan Repayment Program, and Corps members who have become Corps members other than pursuant to contractual obligations under the Scholarship or Loan Repayment Programs. Please note that not all vacancies associated with sites on this list will be for Corps members, but could be for individuals serving an obligation to the NHSC through the Private Practice Option.

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 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: National Institutes of Health Construction Grants42 CFR Part 52b (Final Rule). Type of Information Collection Request: EXTENSION of No. 0925-0424, expiration date 8/31/ 2008. Need and Use of the Information Collection: This request is for OMB review and approval of an extension for the information collection and recordkeeping requirements contained in the regulation codified at 42 CFR Part 52b. The purpose of the regulation is to govern the awarding and administration of grants awarded by NIH and its components for construction of new buildings and the alteration, renovation, remodeling, improvement, expansion, and repair of existing buildings, including the provision of equipment necessary to make the buildings (or applicable part of the buildings) suitable for the purpose for which it was constructed. In terms of reporting requirements: Section 52b.9(b) of the regulation requires the transferor of a facility which is sold or transferred, or owner of a facility, the use of which has changed, to provide written notice of the sale, transfer or change within 30 days. Section 52b.10(f) requires a grantee to submit an approved copy of the construction schedule prior to the start of construction. Section 52b.10(g) requires a grantee to provide daily construction logs and monthly status reports upon request at the job site. Section 52b.11(b) requires applicants for a project involving the acquisition of existing facilities to provide the estimated cost of the project, cost of the acquisition of existing facilities, and cost of remodeling, renovating, or altering facilities to serve the purposes for which they are acquired. In terms of recordkeeping requirements: Section 52b.10(g) requires grantees to maintain daily construction logs and monthly status reports at the job site. Frequency of Response: On occasion. Affected Public: Non-profit organizations and Federal agencies. Type of respondents: Grantees. The estimated respondent burden is as follows:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of chewable tablets containing ivermectin, fenbendazole, and praziquantel for the treatment and control of various internal parasites and for the prevention of canine heartworm disease in adult dogs.

The Food and Drug Administration (FDA) is amending its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary. Currently, manufacturers provide baseline reports to FDA that include the FDA product code and the premarket approval or premarket notification number. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is removing the requirement for baseline reports. The removal of this requirement will eliminate unnecessary duplication and reduce the manufacturer's reporting burden. FDA is amending the regulation in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event we receive a significant adverse comment and withdraw this direct final rule.

This notice announces a public meeting to discuss payment determinations for specific new Physicians' Current Procedural Terminology (CPT) codes for clinical laboratory tests. The meeting provides a forum for interested parties to make oral presentations and submit written comments on the new codes that will be included in Medicare's Clinical Laboratory Fee Schedule for calendar year 2009, which will be effective on January 1, 2009. The meeting will address technical issues relating to payment determinations for a specified list of new clinical laboratory codes. The development of the codes for clinical laboratory tests is largely performed by the CPT Editorial Panel and will not be further discussed at the CMS meeting.

The Interagency (AHRQ-FDA-NIH) Pediatric Devices Working Group is holding a workshop to gather information about the development of pediatric devices.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatPostmarketing Individual Case Safety Reports.'' This draft guidance consolidates and revises information in two existing draft guidances pertaining to electronic submission of postmarketing individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments). The submission of ICSRs and ICSR attachments in an electronic format significantly improves the agency's efficiency in processing, archiving, and reviewing the reports.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and make those findings publicly available. This draft guidance informs industry of how FDA intends to comply with the FDAAA requirement. Specifically, the draft guidance describes procedures and responsibilities for updating information on susceptibility test interpretive criteria, susceptibility test methods, and quality control parameters in the labeling for systemic antibacterial drug products for human use. This draft guidance also describes procedures for making corresponding changes to susceptibility test interpretive criteria for antimicrobial susceptibility testing (AST) devices.

The Health Resources and Services Administration (HRSA) is amending the uniform waiver standards for Ryan White HIV/AIDS Program grantees requesting a core medical services waiver for fiscal year (FY) 2009 and beyond. Title XXVI of the Public Health Service (PHS) Act, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White HIV/AIDS Program), requires that grantees expend 75 percent of Parts A, B, and C funds on core medical services, including antiretroviral drugs, for individuals with HIV/AIDS identified and eligible under the legislation. HRSA has issued waiver standards for grantees under Parts A, B, and C of Title XXVI of the PHS Act. This Federal Register notice seeks to make public the final notice of Uniform Standard for Waiver of Core Medical Services Requirements for Grantees Under Parts A, B, and C effective FY 2009.

Notice is hereby given for the dates and locations for one informational meeting and three Tribal consultations on the Computerized Tribal IV-D Systems and Office Automation Notice of Proposed Rulemaking (NPRM). On June 11, 2008, the Federal Register will publish an NPRM that would enable Tribes and Tribal organizations currently operating a comprehensive Tribal Child Support Enforcement program under Title IV-D of the Social Security Act (the Act) to apply for and receive direct Federal funding for the costs of child support automated data processing. This proposed rule addresses the Secretary's commitment to provide instructions and guidance to Tribes and Tribal organizations on requirements for applying for, and upon approval, securing Federal Financial Participation (FFP) under the Tribal IV-D program in the costs of installing, operating, maintaining, and enhancing child support automated data processing systems. The public comment period for this regulation will be 60 days from the date of the publication of the NPRM. The Federal Office of Child Support Enforcement (OCSE) will host one meeting to introduce the proposed rule and three consultations to receive public comment on the proposed rule. This notification provides specific information for the informational meeting and consultations.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the following U.S. Patent Applications to Systems Medicine, Inc., which is located in Tucson, Arizona. 1. PCT Patent Application No. PCT/US2006/031814 entitled ``Human Monoclonal Antibodies that Specifically Bind IGF-II'' [HHS Ref. Nos. E- 217-2005/0, 1, and 2]; and 2. PCT Application Serial No. PCT/US2007/66180 entitled ``Human IGF-I-Specific and IGF-I and IGF-II Cross-Reactive Human Monoclonal Antibodies'' [HHS Ref. No. E-336-2005/0]. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of the antibodies and their method of use in the Licensed Patent Rights for the treatment of human cancers

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. Proposed Collection: Title: NIH-American Association for Retired Persons (AARP) Comprehensive Lifestyle Interview by Computer (CLIC) Study. Type of Information Collection Request: New. Need and Use of Information Collection: The Nutritional Epidemiology Branch of the Division of Cancer Epidemiology and Genetics of the National Cancer Institute has planned this study to evaluate the feasibility of using these three new computerized questionnaires as well as the Diet and Health Questionnaire (DHQ), a well-established food frequency questionnaire in a population of early-to-late-middle-aged men and women. Participants will be asked to complete one of four different series (pathways) of computerized questionnaires over a 90 day period, with some questionnaires in a series being completed twice. This evaluation study comprises the necessary performance and feasibility tests for the new computerized questionnaires, which will provide an opportunity to assess the possibility of administering computerized questionnaires in future large prospective cohort studies. The computerized questionnaires will support the ongoing examination between cancer and other health outcomes with nutritional, physical activity, and lifestyle exposures. The computerized questionnaires adhere to The Public Health Service Act, Section 412 (42 U.S.C. 285a-1) and Section 413 (42 U.S.C. 285a-2), which authorizes the Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) to establish and support programs for the detection, diagnosis, prevention and treatment of cancer; and to collect, identify, analyze and disseminate information on cancer research, diagnosis, prevention and treatment. Frequency of Response: Either 2 or 4 times, depending on the pathway. Affected Public: Individuals. Type of Respondents: U.S. adults (aged 50 and over). The annual reporting burden is displayed in the table below. The estimated total annualized burden hours being requested is 2616. The annualized cost to respondents is estimated at: $46,242. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

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: ``Overcoming Barriers to Expanded Health Information Exchange (HIE) Participation in Indiana.'' 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.

The Food and Drug Administration (FDA) is providing notice that it has approved a supplemental new animal drug application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The approved NADA provides for the veterinary prescription use of a sustained-release injectable moxidectin formulation for prevention of heartworm disease and treatment of existing hookworm infections in dogs. The supplemental NADA adds animal safety information to product labeling.

The U.S. Department of Health and Human Services (HHS), Office on Women's Health (OWH) announces its new leadership of the National Bone Health Campaign and invites public and private sector bone health- and girls' health-related organizations to participate as collaborating partners to provide advice on the development and dissemination of the campaign materials and messages.

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. Proposed Collection: Title: Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO). Type of Information Collection Request: REVISION (OMB : 0925-0407, current expiry date 10/31/2008). Need and Use of Information Collection: This trial is designed to determine if screening for prostate, lung, colorectal and ovarian cancer can reduce mortality from these cancers which currently cause an estimated 254,900 deaths annually in the U.S. The design is a two-armed randomized trial of men and women aged 55 to 74 at entry. OMB first approved this study in 1993 and has approved it every 3 years since then through 2008. During the first approval period a pilot study was conducted to evaluate recruitment methods and data collection procedures. Recruitment was completed in 2001 and data collection continues through 2008. When participants enrolled in the trial they agreed to be followed for at least 13 years from the time of enrollment. The current number of respondents in the study is 136, 341; this is down from the total initially due to deaths. The primary endpoint of the trial is cancer-specific mortality for each of the four cancer sites (prostate, lung, colorectum, and ovary). In addition, cancer incidence, stage shift, and case survival are to be monitored to help understand and explain results. Biologic prognostic characteristics of the cancers will be measured and correlated with mortality to determine the mortality predictive value of these intermediate endpoints. Basic demographic data, risk factor data for the four cancer sites and screening history data, as collected from all subjects at baseline, will be used to assure comparability between the screening and control groups and make appropriate adjustments in analysis. Further, demographic and risk factor information may be used to analyze the differential effectiveness of screening in high versus low risk individuals. Frequency of Response: Annually. Affected Public: Individuals. Type of Respondents: Adult men and women. The estimated total annual burden hours requested is 11,401. The annualized cost to respondents is estimated at $219,919 per year, for a total of $659,756 over the proposed three year renewal. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

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 and recordkeeping requirements for distribution and use of Veterinary Feed Directive drugs and animal feeds containing Veterinary Feed Directive drugs.