Department of Health and Human Services August 25, 2008 – Federal Register Recent Federal Regulation Documents
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Over the Counter Cough and Cold Medications for Pediatric Use; Notice of Public Hearing
The Food and Drug Administration (FDA) is announcing a public hearing to obtain input regarding over-the-counter (OTC) cough and cold drugs marketed for pediatric use. Many of these nonprescription cough and cold drug products are marketed under the OTC Drug Review, which established a monograph describing the conditions under which certain OTC ingredients are considered to be generally recognized as safe and effective. Recently, safety and efficacy concerns have been raised regarding the pediatric dosing and use of certain active ingredients in OTC cough and cold drug products. FDA is developing a proposed rule to revise the pediatric labeling contained in the Final Monograph for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. At this public hearing, FDA is interested in obtaining public comment about certain scientific, regulatory, and product use issues as it proceeds with the rulemaking and reviews new drug applications (NDAs) for these ingredients. Dates and Times: The public hearing will be held on October 2, 2008, from 8 a.m. to 5 p.m. Location: The public hearing will be held at the Sheraton Washington North Hotel, 4095 Powder Mill Rd., Beltsville, MD 20705.
FDA Regulations; Technical Amendment
The Food and Drug Administration (FDA) is amending a regulatory hearing process regulation to correct an inaccurate citation, and regulations pertaining to biological products to correct two typographical errors. FDA is also amending certain medical device regulations to include references to and mailing address information for the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH). This action is being taken to ensure the accuracy of FDA's regulations.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mental Models Study of Communicating With Health Care Providers About the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women With Chronic Conditions
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act
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 the reporting and recordkeeping requirements of FDA's regulations implementing the Federal Import Milk Act (FIMA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submission for OMB Review; Comment Request; National Institutes of Health Construction Grants
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, 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 June 16, 2008, pages 34026-34027, 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 NIH may not conduct or sponsor, and the respondent is not required to respond to, information that has been extended, revised or implemented on or after October 1, 2008, unless it displays a currently valid OMB control number. 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:
Privacy Act of 1974; Report of Modified or Altered System Medical, Health and Billing Records System
In accordance with the requirements of the Privacy Act of 1974, IHS is proposing to modify or alter an SOR, ``Medical, Health and Billing Records,'' System No. 09-17-0001. IHS is proposing to amend routine use number 10 to be more consistent with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule language, 45 CFR 164.512(b) by changing the language to state ``which are authorized by applicable Federal, State, Tribal or local law * * *,'' which would give IHS the discretion of allowing additional disclosures. For example, this change will give IHS the discretion to disclose controlled substance prescription data to a centralized database administered by an authorized State public health entity, such as state prescription drug monitoring programs (PMP). IHS is also proposing to add routine use number 25 to meet the newly established requirement by the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information and to Comply with HHS Incident Reporting and Handling Requirements. Effective Dates: IHS filed an altered/modified system report with the Chair of the House Committee on Oversight and Government Reform, the Chair of the Senate Committee on Homeland Security and Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, OMB on August 25, 2008. To ensure that all parties have adequate time in which to comment, the modified SOR will become effective 40 days from the publication of the notice, or from the date it was submitted to OMB and the Congress, whichever is later, unless IHS invites comments on all portions of this notice.
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service; Health Promotion/Disease Prevention Grantee Survey
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: 0917-NEW, ``Indian Health Service Health Promotion/Disease Prevention Grantee Survey.'' Type of Information Collection Request: This is a one time survey to fulfill an OMB request for an independent external evaluation collection, 0917- NEW, ``Indian Health Service Health Promotion/Disease Prevention (HP/ DP) Grantee Survey.'' Form(s): The Indian Health Service HP/DP Interview Survey. Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native (AI/AN) people to the highest possible level by providing comprehensive health care and preventive health services. HP/DP is one of the three IHS Director's Initiatives to reduce health disparities among AI/AN populations through a coordinated and systematic approach to enhance health promotion and chronic disease prevention approaches at the local, regional, and national levels. The HP/DP competitive grant was established in 2005 to encourage Tribal and urban Indian programs to fully engage their local schools, communities, health care providers, health centers, faith-based/ spiritual communities, senior centers, youth programs, local governments, academia, non-profit organizations, and many other community sectors to work together to enhance and promote health and prevent chronic disease in their communities. Thirty-three Tribal/urban Indian organizations and programs were awarded competitive grants to expand and enhance health promotion and disease prevention to address health disparities among AI/AN populations. To conduct a thorough evaluation of the grant program, 29 telephone and four face-to-face interviews will be conducted to collect information to complete a quantitative and qualitative evaluation of the HP/DP grant program. The teleconference interviews may include one staff member per site. Each of the Tribal/urban organization/ programs will determine the number of their staff members that will participate in the interview. The evaluation will include an assessment of whether HP/DP grantees achieve measurable health outcomes, synthesize the evaluation findings, and include a written report with recommendations to enhance program effectiveness. The information gathered will be used to prepare a final report for OMB. Affected Public: Individuals. Type of Respondents: Tribal/Urban organizations program staff. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Average burden hour per response, and Total annual burden hour(s).
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service; HIV Knowledge/Attitudes/Practice Customer Survey
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: 0917-NEW, ``Indian Health Service HIV Knowledge/Attitudes/Practice Customer Survey.'' Type of Information Collection Request: This is a one time survey to deliver the mission of the IHS and Centers for Disease Control (CDC) national guidelines collection, 0917-NEW, ``Indian Health Service HIV Knowledge/Attitudes/ Practice Customer Survey.'' Form(s): The Indian Health Service Customer Survey. Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native (AI/AN) people to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission, the Division of Epidemiology and Disease Prevention (DEDP) and the Human Immunodeficiency Virus (HIV) Program collaborate to provide programmatic, technical, and financial assistance to IHS Areas and Service Units for improving prevention, detection, and treatment of infectious and chronic disease, specifically in this case, HIV and Sexually Transmitted Disease (STD). The ``HIV Knowledge/Attitudes/Practice Customer Survey'' (hereto referred to as Customer Survey), will provide the information needed to understand the most effective and appropriate methods to complete these goals. With the information collected from patients, we will be able to offer recommendations to Service Units on how to best scale up screening for sensitive topics such as HIV and STDs in AI/AN communities. Also, the information will give IHS the tools to assist our Service Units with implementation of current national recommendations by CDC. At the moment, we are encouraging uptake of current CDC national recommendations; however, without this information, we are unable to maximize effectiveness, dispel myths, and identify misinformation. Voluntary customer surveys will be conducted through self- administered questionnaires, face-to-face interviews, and potentially electronic media. The information gathered will be used by DEDP and the HIV Program to identify how patients would prefer to be offered expanded testing in a way that is respectful, confidential, and effective. Affected Public: Individuals. Type of Respondents: IHS customers. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Average burden hour per response, and Total annual burden hour(s).
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