Department of Health and Human Services January 2006 – Federal Register Recent Federal Regulation Documents

The Agency for Healthcare Research and Quality (AHRQ) invites individuals and organizations to nominate primary and secondary prevention topics pertaining to clinical preventive services that they would like the United States Preventive Services Task Force (USPSTF) to consider for review. A list of topics that have been recently reviewed or are currently under review by the USPSTF is listed below in the supplementary information section. The USPSTF is an independent panel of experts that makes evidence- based recommendations regarding the provision of clinical preventive services. Clinical preventive services include screening, counseling and preventive medications. The USPSTF makes recommendations about preventive services for asymptomatic peoplepeople without recognized signs or symptoms of the specific conditions targeted by the preventive service. Topics can be nominated by individuals, organizations, evidence- based practice centers (EPC) and USPSTF members. The USPSTF will consider nominations and prioritize topics for review based on the following set of criteria: Public health importance (burden of suffering, potential of preventive service to reduce the burden); new evidence that has the potential to change prior recommendations including inactive ones; and, potential for greatest Task Force impact (e.g., clinical controversy, practice does not reflect evidence, inappropriate timing in delivery of services). The USPSTF will prioritize topics for which there is a performance gap and the potential to significantly improve clinical practice. Individuals and organizations may nominate new topics or topics previously reviewed by the USPSTF. Basic Topic Nomination Requirements: Nominations must be no more than 500 words in length and must include the following information. Nominations may include an appendix that contains references and supporting documents (not included in word count). 1. Name of topic. 2. Rationale for consideration by the USPSTF, to include: a. Primary or secondary prevention topic (screening, counseling or preventive medication). b. Primary care relevance (aplicable clinical preventive service must be initiated in the primary care setting which can be defined as family practice, internal medicine, pediatrics or obstetrics/gynecology and provided by a primary care provider). c. Description of public health importance (burden of disease/ suffering, potential of preventive service to reduce burden, including effective interventions). Citations and supporting documents are recommended. d. Summary of new evidence, if any, that has potential to affect the Task Force's recommendation on a previously reviewed topic. Please refer to https://preventiveservices.ahrg.gov for USPSTF recommendations. Citations and supporting documents are recommended. e. Description of potential impact of USPSTF's review of the topic, i.e., change in clinical practice, research focus, etc.

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Linde Ceramics Plant, in Tonawanda, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 8, 2005, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is announcing the availability of two guidances for industry entitled ``Clinical Studies Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format'' and ``Adverse Reactions Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' These guidances are two of a series of guidance documents intended to assist applicants in complying with the new requirements in the final rule on the content and format of labeling for human prescription drug and biological products published elsewhere in this issue of the Federal Register.

The purpose of this solicitation of comments is to assist HRSA in determining whether criteria developed by the Organ Procurement and Transplantation Network (OPTN) concerning organs procured from living donors, including those concerning the allocation of organs from living donors, should be given the same status, and be subject to the same enforcement actions, as other OPTN policies.

The National Vaccine Program Office (NVPO), a program office within the Office of Public Health and Science, U.S. Department of Health and Human Services (HHS), is soliciting nominations of qualified candidates to be considered for appointment as voting representative members to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Consistent with the National Vaccine Plan, the Committee advises and makes recommendations to the Assistant Secretary for Health in his/ her capacity as the Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non-government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.

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: Actigraph Accelerometer Validation Study. Type of Information Collection Request: New. Need and Use of Information Collection: The NCI is collaborating with other NIH Institutes on a proposed longitudinal study of Hispanic subpopulations in the United States referred to as the Hispanic Community Health Study. The Hispanic population is now the largest minority population in the U.S. with a projected three-fold growth by 2050. Hispanic subgroups are influenced by a number of chronic disease risk factors associated with immigration from different cultural settings and environments. These factors include diet, physical activity, community support, working conditions, and access to health care. Hispanic groups have higher rates of obesity and diabetes than non-Hispanic groups, but have lower coronary disease and cancer (all sites) mortality. There are also observed differences in health outcomes between Hispanic subgroups. For example, Puerto Ricans have a four-fold higher asthma prevalence than Mexican-Americans. Hispanic populations are understudied with respect to many diseases and risk factors. Their projected population growth underscores the need for accurate evaluation of their disease burden and risk. A vast amount of research suggests that the level of physical activity influences many of the chronic diseases and conditions of interest, including obesity, diabetes, cardiovascular disease, and cancer. To better understand the relationship between physical activity and chronic disease, and to make specific activity prescriptions, it is necessary to be able to accurately assess levels and types of activity. In particular, better methods are needed to improve the validity and reliability of physical activity assessment instruments to better assess the frequency, duration, and intensity of physical activity. For that reason, NCI plans to evaluate the use of a new type of accelerometer, a small device worn on a belt at the waist that measures and records movement, capturing movement intensity and duration and associating it with clock-time. This new accelerometer will be used in the Hispanic Community Health Study and will allow examination of levels as well as patterns of activity. Physical activity was measured with accelerometers in the nationally representative 2003-2006 National Health and Nutrition Examination Survey (NHANES) (OMB: 0920- 0237, October 15, 2004, Vol 69, pp. 61253-61254). NHANES provides estimates for Mexican-American, but not other Hispanic subgroups. Between the time of the NHANES and the Hispanic Community Health Study, there has been a change in the technology of the accelerometer used in NHANES. To allow comparison of the physical activity data that will be collected from the four Hispanic subgroups in the Hispanic Community Study to the data collected with the previous technology used in NHANES, a cross-validation study is needed. The proposed study, the ActiGraph Accelerometer Validation Study, will serve this purpose. It is a cross-validation study comparing the two ActiGraph accelerometer models under different circumstances of walking or jogging in differing age groups and for both genders. Frequency of response: One-time study. Affected Public: Individuals. Type of Respondents: Healthy adults between the ages of 18-74 years. The annual reporting burden is as follows: Estimated Number of Respondents: 144; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 1.5; and Estimated Total Annual Burden Hours Requested: 186. The annualized cost to respondents is estimated at: $3,288.

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 worldwide to practice the invention embodied in U.S. Patent Application Number 60/602,334 filed August 18, 2005, entitled ``Biomarkers for Osteoarthritis,'' to PeptiFarma, Inc., having a place of business in San Diego, CA 92191. The contemplated exclusive license may be limited to an FDA approvable human diagnostic for osteoarthritis. The United States of America is an assignee of the patent rights in this invention.

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 Institute of Environmental Health Sciences (NIEHS), 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: Environmental Factors in the Development of Polycystic Ovary Syndrome. Type of Information Collection Request: Revision of OMB No. 0925-0483 and expiration date 3/31/2006. Need and Use of Information Collection: The purpose of this study is to identify a cohort of living female twin pairs in which at least one member is likely to have Polycystic Ovary Syndrome (PCOS) for future study. Potential participants (~3,700) will come from the Mid-Atlantic Twin Registry (MATR) and were chosen based on their answers to several questions (in a preliminary MATR survey) concerning irregular periods and a history of cystic ovaries. The instrument to be used here will be administered by telephone by professional interviewers at the MATR. It contains 17 simple and direct questions and will take about 10 minutes to complete. Its contents deal with the frequency of menstrual periods, a history of polycystic ovaries, obesity, excess facial hair and other evidence of hyperandrogenism. Since this is such a short telephone survey, participants will receive no prior notification. Informed consent will be asked for verbally over the phone at the time of the interview. All participants will be asked about their willingness to participate in future studies if their answers meet certain criteria. The major objectives of future studies using this cohort are to determine more reliable concordance rates for PCOS in monozygotic and dizygotic twins, establish baseline heritability estimates, and develop hypotheses concerning possible pathogenetic and/or environmental factors. The findings from this study will aid in developing: (1) Genetic tests to identify high risk women; (2) preventative strategies; and (3) more effective therapies for PCOS and related syndromes such as type 2 diabetes, obesity, idiopathic hyperandrogenism, and male pattern baldness. Frequency of Response: One time. Affected Public: Individuals or households. Type of Respondents: Adult women. The annual reporting burden is as follows: Estimated Number of Respondents: 3,700; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.167; and Estimated Total Annual Burden Hours Requested: 206 per year for 3 years. The annualized cost to respondents is estimated at $6,179.00. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. 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.

In compliance with the provisions of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comments on proposed data collection projects, the National Institutes of Health (NIH), National Cancer Institute (NCI) 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 Survey of Primary Care Physicians' Recommendations and Practice for Breast, Cervical, Colorectal, and Lung Cancer Screening. Type of Information Collection Request: New. Need and Use of Information Collection: This study will obtain current, national data on primary care physicians' knowledge, attitudes, recommendations, and practices related to screening for breast, cervical, colorectal, and lung cancer. There have been substantial changes in guidelines and/or technologies for these types of cancer screening in recent years. The data collected in this study will support and further NCI work in monitoring and evaluating providers' cancer control knowledge, attitudes, and practices and their impact on population health, as well as enable monitoring of progress toward major cancer control goals. Two questionnaires, one covering breast and cervical cancer screening and the other colorectal and lung cancer screening, will be administered by mail or telephone to a randomly-selected national sample of primary care physicians. Frequency of Response: One Time. Affected Public: Medical practices, clinics, or other health care organizations. Type of Respondents: Primary Care Physicians. Burden estimates are as follows:

The National Institute for Occupational Safety and Health (NIOSH) proposes to change the selection of target organs used in dose reconstructions NIOSH produces under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) for energy employees with lymphoma cancers. This proposed change is in response to an evaluation by NIOSH of current scientific data on lymphoma, which revealed that the site of the radiation injury can differ from the site of the tumor or cancer origin documented in the medical files of a lymphoma cancer patient. The new process for selecting dose reconstruction target organs for energy employees with lymphoma cancers would include selecting the target organ that would have received the highest radiation dose from among relevant, possibly irradiated organs, as determined through the dose reconstruction process, when the identity of the target organ is in question. This change would result in the Department of Labor calculating higher probability of causation determinations for select lymphoma cases among previously decided and current EEOICPA cancer claims.

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.

The Department of Health and Human Services, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Indian Health Service (IHS) is providing a 60-day advance opportunity for public comment on a proposed extension of current information collection activity to be submitted to the Office of Management and Budget for review.

Federal grant applicants must complete a three-step registration process before applying for a federal grant opportunity through Grants.gov. Grants.gov is the federal government's free, single, and secure site for finding and submitting applications electronically for federal grant funding. It is part of the ongoing implementation of Electronic Government (E-Government) and a key component of the President's Management Agenda. Expanding electronic government makes it simpler for the public to receive high-quality services from the federal government in addition to improving the federal government's efficiency in the delivery of its services. To protect the applicant and the applicant's information, and to assure federal agencies that they are interacting with officials authorized to submit applications for funding on behalf of applicant entities, an applicant must register with Grants.gov. In fiscal year 2005, 20 out of 26 federal grant making departments and agencies achieved their goals, set through OMB guidance, of making 25 percent of their discretionary funding opportunities available for the electronic submission of applications on Grants.gov and over 15,000 applications were received. Per OMB milestones, in fiscal year 2006 the percentage of discretionary funding opportunities available for electronic submission will increase to 75 percent and then to 100 percent in fiscal year 2007. This planned increase in utilization of the Grants.gov system is indicative of a governmentwide transition to electronic grant processes. The twenty-six federal grant making departments and agencies participating in Grants.gov are: The Departments of Health and Human Services, Housing and Urban Development, Transportation, Education, Agriculture, Justice, Labor, Homeland Security, Defense, Commerce, Veterans Affairs, State, Treasury, Interior, and Energy, and the National Science Foundation, Environmental Protection Agency, National Aeronautics and Space Administration, National Endowment of the Arts, National Endowment of Humanities, Corporation for National & Community Service, U.S. Agency for International Development, National Archives and Records Administration, Small Business Administration, Institute of Museum and Library Services, and Social Security Administration. Each of the federal grant-making departments and agencies listed above are posting funding opportunities and grant application materials on Grants.gov. To facilitate the federal grant application process, this notice encourages prospective applicants to register early. Registering in advance of agencies posting their grant opportunities will eliminate many of the issues that applicants have faced by not meeting registration requirements in time to meet application deadlines. Registering early will allow the Federal agencies and Grants.gov sufficient time to address questions applicants may have in completing the registration process.

The Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational ``Phase 1'' drugs from complying with the requirements in FDA's regulations. FDA will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. In addition, FDA is making available simultaneously with the publication of this direct final rule, a guidance document setting forth recommendations on approaches to CGMP compliance for the exempted Phase 1 drugs. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and- comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled ``INDs Approaches to Complying With CGMP During Phase 1'' to provide further guidance on the subject.

The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to amend our current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational ``Phase 1'' drugs from complying with the regulatory requirements. We will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled ``INDsApproaches to Complying With CGMP During Phase 1'' to provide further guidance on the subject.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of January 4, 2006 (71 FR 349). The document announced a public workshop entitled ``UA/FDA Food Labeling Workshop.'' The document was published with a typographical error in the SUPPLEMENTARY INFORMATION section. This document corrects that error.