Department of Health and Human Services October 2010 – Federal Register Recent Federal Regulation Documents

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 the additional criteria and procedures for classifying over-the-counter (OTC) drugs as generally recognized as safe and effective and not misbranded.

The Fostering Connections to Success and Increasing Adoptions Act of 2008 (Pub. L. 110-351) directed HHS to establish assistance payment reimbursement rates for Indian Tribes, tribal organizations and tribal consortia participating in certain child welfare programs authorized under title IV-E of the Social Security Act. These reimbursement rates will be calculated in a manner similar to the Federal Medical Assistance Percentage (FMAP) rates used to reimburse States. This notice describes the Department's proposed methodology for calculating these rates.

The U.S. Department of Health and Human Services, in its role as the Chair of the Interagency Working Group on Youth Programs, is announcing a meeting to solicit input from the public that will inform the development of a strategic plan for federal youth policy.

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: Gulf Worker Study: Gulf Long-Term Follow-Up Study for Oil Spill Clean-Up Workers and Volunteers. Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of the GuLF Study is to investigate potential short- and long-term health effects associated with oil spill clean-up activities and exposures surrounding the Deepwater Horizon disaster; and to create a resource for additional collaborative research on focused hypotheses or subgroups. Over 55,000 persons participating in oil-spill clean-up activities have been exposed to a range of known and suspected toxins in crude oil, burning oil, and dispersants, to excessive heat, and possibly to stress due to widespread economic and lifestyle disruption. Exposures range from negligible to potentially significant, however, potential long-term human health consequences are largely unknown due to insufficient research in this area. Participants will be recruited from across job/exposure groups of primarily English, Spanish, or Vietnamese speaking adults (accommodations for other languages developed as appropriate) who performed oil-spill clean-up- related work (``exposed'') and similar persons who did not (``unexposed'' controls), and followed in either an Active Follow-up Cohort (N~27,000) or a Passive Follow-up Cohort (N~28,000). Exposures will be estimated using detailed job-exposure matrices developed from data from monitoring performed by different agencies and organizations during the crisis, information obtained by interview, and the available scientific literature. We will investigate acute health effects among all cohort members via self-report from the enrollment interview, and via clinical measures and biological samples from Active Follow-up Cohort members only. All cohort members will be followed for development of a range of health outcomes through record linkage (e.g., cancer, mortality) and possibly through linkage with routinely collected health surveillance data (collected by health departments and the CDC) or with electronic medical records. Recruitment of subjects should begin in late 2010, with telephone interviews and the baseline home visits conducted within 18 months.

In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, the National Cancer Institute (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collected below. This proposed information collection was previously published in the Federal Register on August 4, 2010 (75 FR 46945) and allowed 60 days for public comment. No public comments were 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 March 1, 2011, unless it displays a valid OMB control number. Proposed Collection: Title: Drug Accountability Record (NCI) (Form NIH 2564) (OMB No.0925-0240). Type of Information Collection Request: Extension with changes. Need and Use of Information Collection: Food and Drug Administration (FDA) regulations require investigators to establish a record of the receipt, use and disposition of all investigational agents. The National Cancer Institute (NCI), as a sponsor of investigational drug trials, has the responsibility to assure the FDA that investigators in its clinical trials program are maintaining systems for drug accountability. In order to fulfill these requirements, a standard Investigational Drug Accountability Report Form (NIH 2564) was designed to account for drug inventories and usage by protocols. The data obtained from the drug accountability record will be used to keep track of the dispensing of investigational anticancer agents to patients. It is used by NCI management to ensure that investigational drug supplies are not diverted for inappropriate protocol or patient use. The information is also compared to patient flow sheets (protocol reporting forms) during site visits conducted for each investigator once every three years. All comparisons are done with the intention of ensuring protocol, patient and drug compliance for patient and drug compliance for patient safety and protections. Frequency of Response: Approximately 16 times per year. Affected Public: Private sector including businesses, other for-profit organizations, and non-profit institutions. Type of Respondents: Investigators, pharmacists, nurses, pharmacy technicians, and data managers. The annualized respondents' burden is estimated to require 6,714 hours (Table 1). There are no capital costs, operating costs, and maintenance cost to report.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Complementary and Alternative Medicine (NCCAM), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on August 25, 2010 (Vol. 75, No. 164, p. 52349) and allowed 60 days for public comment. There was one public comment received during this time. 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: NCCAM Office of Communications and Public Liaison Communications Program Planning and Evaluation Research. Type of Information Collection Request: Extension. Need and Use of Information Collection: To carry out NCCAM's legislative mandate to educate and disseminate information about complementary and alternative medicine (CAM) to a wide variety of audiences and organizations, the NCCAM Office of Communications and Public Liaison (OCPL) requests clearance to carry out (1) formative and (2) evaluative research of a variety of print and online materials, outreach activities, and messages to maximize their impact and usefulness. OCPL wishes to continue to carry out formative research to further understand the knowledge, attitudes, and behaviors of its core constituent groups: Members of the general public, researchers, and providers of both conventional and CAM health care. In addition, it seeks to test newly formulated messages and identify barriers and impediments to the effective communication of those messages. With this formative audience research, OCPL tests audience responses to NCCAM's fact sheets, Web content, and other materials and messages. Clearance is also requested to continue evaluative research on existing materials and messages, as part of OCPL's ongoing effort to develop a comprehensive program of testing and evaluation of all of its communications strategies. This evaluative research will include pilot testing of recently developed messages and information products such as consumer fact sheets and brochures. It will address the need to evaluate the processes by which new materials and messages were developed, the effectiveness of an outreach activity or the extent to which behaviors were changed by the message, and the impact of a message on health knowledge and behaviors. The tools to collect this information have been selected to minimize burden on NCCAM's audiences, produce or refine messages that have the greatest potential to influence target audience attitudes and behavior in a positive manner, and to use Government resources efficiently. They may include individual in-depth interviews, focus group interviews, intercept interviews, self-administered questionnaires, gatekeeper reviews, and omnibus surveys. The data will enhance OCPL's understanding of the unique information needs and distinct health-information-seeking behaviors of its core constituencies, and the segments within these constituencies with special information needs (for example, among the general public these segments include cancer patients, the chronically ill, minority and ethnic populations, the elderly, users of dietary supplements, and patients integrating complementary therapies with conventional medical treatments). Frequency of Response: On occasion. Affected Public: Individuals and households; non-profit institutions; Federal Government; State, Local, or Tribal Government. Type of Respondents: Adult patients; members of the public; health care professionals; organizational representatives. The annual reporting burden is as follows: Estimated Number of Respondents: 2,500; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 0.58; and Estimated Total Burden Hours Requested: 2,109 for the 3-year clearance period (approximately 703 hours annually). The annualized cost to respondents is estimated at $18,123. There are no Capital Costs, Operating Costs, or Maintenance Costs to report.

The Health Resources and Services Administration published an Agency Information Collection document in the Federal Register of September 17, 2010 (FR Doc. 201-023260), on page 57037, regarding the Black Lung Clinics Program Database (OMB No. 0915-0292). In the burden table, the Total responses, Hours per response and Total burden hours are incorrect.

As stipulated by the Federal Advisory Committee Act, as amended (5 U.S.C. App), the U.S. Department of Health and Human Services is hereby announcing renewal of the charter for the Chronic Fatigue Syndrome Advisory Committee (CFSAC).

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 communication studies involving biological products, including vaccines and blood products, that are regulated by FDA. This information will be used to explore concepts of interest and assist in the development and modification of communication messages and campaigns to fulfill the Agency's mission to protect the public health.

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 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 the National Consumer Surveys on Understanding the Risks and Benefits of FDA-Regulated Medical Products.