Department of Health and Human Services May 2005 – Federal Register Recent Federal Regulation Documents

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), 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.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.'' This guidance presents FDA's general policy for implementing the channels of trade provision in the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food Quality Protection Act of 1996 (the FQPA), for food containing residues of pesticide chemicals, for which tolerances have been revoked, suspended, or modified pursuant to dietary risk considerations.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Devices; Medical Device Tracking'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This final rule removes 42 CFR part 50, subpart A, ``Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science,'' and replaces it with a new, more comprehensive part 93, ``Public Health Service Policies on Research Misconduct.'' The proposed part 93 was published for public comment on April 16, 2004. The final rule reflects both substantive and non-substantive amendments in response to public comments and to correct errors and improve clarity, but the general approach of the NPRM is retained. The purpose of the final rule is to implement legislative and policy changes applicable to research misconduct that occurred over the last several years, including the common Federal policies and procedures on research misconduct issued by the Office of Science and Technology Policy on December 6, 2000.

This notice is to inform interested parties of corrections made to the CCF Demonstration Program published on Friday, April 29, 2005. The following corrections should be noted: Under IV.6 Other Submission Requirements, the correct address to mail and hand deliver applications is: U.S. Department of Health and Human Services (HHS), Attention: Eduardo Hernandez, Administration for Children and Families Office of Community Services, Operations Center, Compassion Capital Fund Demonstration Program, 1515 Wilson Boulevard, Suite 100, Arlington, Virginia 22209. Phone: 1-800-281-9519. E-mail: OCS@lcgnet.com. The only changes to the CCF Demonstration Program Announcement are explicitly stated in this Notice of Correction. All applications must still be sent on or before the deadline date of June 13, 2005. For further information contact the OCS Grants Operations Center at the above phone number or address.

The Food and Drug Administration (FDA) is withdrawing approval of one new drug application (NDA). CollaGenex Pharmaceuticals, Inc., notified the agency in writing that PERIOSTAT (doxycycline hyclate) 20- milligram (mg) capsules were no longer marketed and requested that approval of NDA 50-774 be withdrawn. FDA has determined that PERIOSTAT (doxycycline hyclate) 20-mg capsules were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for doxycycline hyclate 20-mg capsules.

The Food and Drug Administration (FDA) is announcing a series of domestic public meetings to discuss the final regulation implementing section 306 (Maintenance and Inspection of Records) of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). The purpose of these public meetings is to provide to the public information and an opportunity to ask questions regarding the final rule.

The FTC and HHS are planning to host a public workshop, ``Marketing, Self-Regulation & Childhood Obesity,'' to explore self- regulatory marketing initiatives in the food and beverage industry that respond to concerns about childhood obesity. The event is open to the public and there is no fee for attendance. For admittance to the conference center, all attendees will be required to show a valid form of photo identification, such as a driver's license. The FTC will accept pre-registration for this workshop. Pre- registration is not necessary to attend, but is encouraged so that we may better plan this event. To pre-register, please e-mail your name and affiliation to the e-mail box for the workshop, at FoodMarketingtoKids@ftc.gov. When you pre-register, we collect your name, affiliation, and your e-mail address. This information will be used to estimate how many people will attend and better understand the likely audience for the workshop. We may use your e-mail address to contact you with information about the workshop. Under the Freedom of Information Act (FOIA) or other laws, we may be required to disclose the information you provide to outside organizations. For additional information, including routine uses permitted by the Privacy Act, see the Commission's Privacy Policy at https://www.ftc.gov/ftc/privacy.htm. The FTC Act and other laws the Commission administers permit the collection of this contact information to consider and use for the above purposes. Additional information about the workshop will be posted on the FTC's Web site at https://www.ftc.gov/bcp/workshops/foodmarketingtokids/ index.htm.

In compliance with he requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed date collection projects, the Office of the Director (OD), 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: Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors42 CFR Part 50, Subpart F. Type of Information Collection Request: Revision of OMB No. 0925-0417, expiration date 09/31/2005. Need and Use of Information Collections: This is a request for OMB approval for the information collection and recordkeeping requirements contained in the final rule 42 CFR part 50, subpart F and Responsible Prospective Contractors: 45 CFR part 94. The purpose of the regulations is to promote objectivity in research by requiring institutions to establish standards which ensure that there is no reasonable expectation that the design, conduct, or reporting of research will be biased by a conflicting financial interest of an investigator. Frequency of Response: On occasion. Affected Public: Individuals or households; business or other for-profit; not-for-profit institutions; State local or tribal government. Type of Respondents: Any public or private entity or organization. The annual reporting burden is as follows: Estimated Number of Respondents: 42,800; Estimated Number of Responses per Respondent: 1.60; Average Burden Hours per Response: 3.40; and Estimated Total Annual Burden Hours Requested: 232,000. The annualized costs to respondents is estimated at: $8,120,000. Operating costs and/ or Maintenance costs are $4,633. 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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. For Further Information Contact: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Mikia Currie, Assistant Project Clearance Officer, Office of Extramural Research (OER) Office of Policy for Extramural Research Administration (OPERA), 6705 Rockledge Drive, Room 1198, Bethesda, MD 20892-7974 or call non-toll-free number (301) 435- 0941, e-mail your request including your address to: curriem@od.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

In compliance with the provisions of Section 3507(1)(D) 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) 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 October 29, 2004 (Volume 69, No. 209, pages 63159-63160) 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 October 1, 1995, unless it displays a currently valid OMB number. Proposed Collection: Title: Survey of Colorectal Cancer Screening Policies, Programs, and Systems in U.S. Health Plans. Type of Information Collection Request: New. Need and Use of Information collection: This study will obtain information on policies, programs, and practices for colorectal cancer screening among health plans in the U.S. The purpose of the study is to assess (1) Health plan policies, programs, and practices for colorectal cancer screening; (2) health plan activities in response to the National Committee on Quality Assurance's new Health Employer Data Information Set measure for colorectal cancer screening; and (3) characteristics of health plans and plan policies and activities that may be associated with higher rates of colorectal cancer screening. A questionnaire will be administered by mail or Internet using a national sample of health plans. Study participants will be health plan medical directors or administrators, and they will select their preferred response mode. Burden estimates are as follows:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health 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 July 19, 2004 on page 43003 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 October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Evaluation of National Cancer Institute's Central Institutional Review Board to Improve Cancer Clinical Trials System. Type of Information Collection Request: NEW. Need and Use of Information Collection: This study will evaluate the effectiveness of the Central Institutional Review Board (CIRB), a pilot project designed to streamline the protocol activation process by conducting human subject protection reviews that can be utilized by local Institutional Review Boards (IRB) for facilitated approval of multi-institutional, NCI- sponsored Phase 3 clinical trials. This evaluation includes two surveys that will be made available online to minimize respondent burden. The CIRB survey will assess acceptance level and satisfaction of local IRB chairs, coordinators, and principal investigators with the CIRB. The Cooperative Group Staff Survey will assess the opinions and experiences of the operations and regulations staff of the nine Clinical Trials Cooperative Groups about CIRB operations, office processes, and procedures. The findings will provide valuable information concerning whether the CIRB is meeting its intended goals and will provide recommendations for change and further study. Frequency of Response: Once. Affected Public: Registered members of the CIRB and Clinical Trials Cooperative Group Staff. Type of Respondents: IRB chairs, IRB coordinators, principal investigators, and the operations and regulations staff of Clinical Trials Cooperative Groups. The annualized cost to respondents is estimated at $5,500. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Estimated Number of Respondents: 279. Estimated Number of Responses per Respondent: 1. Average Burden per Response: 0.50 hours. Estimated Total Annual Burden Hours Requested: 139.50. The total burden estimate per respondent is shown below.