Department of Health and Human Services January 2005 – 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, 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 regulations requiring the distribution of patient labeling, called Medication Guides, for certain products that pose a serious and significant public health concern requiring distribution of FDA-approved patient medication information.

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Research Services, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. 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: Request for Generic Clearance to collect public comments on the Proposed Standards of Care Regulations covering chimpanzees in the federally supported Chimpanzee Sanctuary System. Type of Information Collection Request: New. Need and Use of Information Collection: The Chimpanzee Health Improvement, Maintenance, and Protection Act of 2000 (Public Law 106-551) requires the Secretary of the Department of Health and Human Services to develop Standards of Care Regulations for chimpanzees in the Sanctuary System. The Act further requires the Secretary to publish the proposed standards in the Federal Register to provide a 60 day period for public comment on the proposed standards. Following receipt of public comments, NCRR/NIH will consider these comments in preparing the final regulations for the sanctuary system. The public includes members of the general population, interested communities (local, regional, and national organizations), and non-profit business entities. Input from the public will allow the NCRR/NIH staff to receive critical review of the standards from different stakeholders, provide a review and analyses of the burden estimated by the government, and help assure that the proposed standards are necessary and current. Frequency of Response: One time event. Affected Public: Non-profit entities serving as a contractor to the government to operate and maintain the federally supported Chimpanzee Sanctuary System. Type of Respondents: Non-profit businesses that possess qualified staff and resources needed to develop, operate, and maintain several hundred chimpanzees. Estimated number of respondents: 1-3. Number Respondents per Response: 1-3. Average Burden Hours Per Response: 15.4. Burden Hours Requested: 186.95. Total annualized cost to respondents is estimated at $8412.75. There is no capital, operating, and/or maintenance costs to report.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for oral use of lincomycin soluble powder to make medicated drinking water for administration to swine for the treatment of swine dysentery or to broiler chickens for the control of necrotic enteritis.

Under provisions of section 1320.13 of Regulations Implementing the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) is requesting approval from the Office of Management and Budget (OMB) approval of the information collection involved in the Rapid Access to Intervention Development (RAID) mechanism. Under this program NIH makes NIH resources available to requesting extramural investigators with the goal of speeding the progress of therapeutic, preventive and/or imaging agents to clinical testing. Since the number of requests from extramural investigators greatly exceeds the available resources of the NIH, the NIH needs to collect scientific background information from the extramural investigators to determine which requests are most meritorious. The instructions on the NIH Web sites identified below explain the procedures for applying. The initial RAID program was developed in 1998 with authorization by the National Cancer Institute (NCI) Board of Scientific Counselors (BSC) and the National Cancer Advisory Board (NCAB). Subsequently, the RAID type programs were expanded within NCI and adopted also by other NIH components [National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)]. However, the requirement for clearance of the information collection burden associated with the programs was not recognized. Officials in NCI believed that the support of the research facilitated by the RAID-type programs was already covered under existing OMB authorized information collections (OMB No. 0925-0001/Exp. 9/2007 and OMB NO. 0925-0002/Exp. 6/2005), which provide for regular exchanges of information between NIH program officials and the investigators, who are supported by NIH discretionary investigator- initiated research grants, to assure that NIH remains responsive to new directions in the research, progress in conducting the research and additional budgetary and scientific resources needed to successfully complete the research. As a consequence, the requirement for specific approval of the information collected in the furtherance of the Federal assistance activity was not formally recognized. At this time, NIH is requesting by emergency clearance procedures that the OMB approve the collection of information under the various existing RAID-type programs and to approve the proposed expansion of the program to accommodate new initiatives under the NIH Director's Roadmap (https://nihroadmap.nih.gov/), which will employ the RAID model to facilitate advances in research by rapid availability of needed resources. Six Raid-like programs are currently in existence; another is shortly to be announced. NCI RAID (https://dtp.nci.nih.gov/docs/raid/ raidindex.html); NCI R*A*N*D (https://dtp.nci.nih.gov/docs/rand/rand index.html); NCI-NIAID Inter-Institute Program for the Development of AIDS-Related Therapeutics (https://dtp.nci.nih.gov/docs/dart/dart/html); NCI RAPID (https://www3.cancer.gov/prevention/rapid/); NCI DECIDE (https://dtp.nci.nih.gov/docs/ddg/ddgdescript.html); NIDDKT1D-RAID (https://www.niddk.nih.gov/fund/diabetesspecailfunds/t1d-raid/ raid.htm); NIH Roadmap RAID program (https://nihroadmap.nih.gov/). The NIH has determined that the continuing collection of information is essential to the mission of the agency and the agency cannot reasonably comply with the normal clearance procedures because public harm is reasonably likely to result and the use of the normal clearance process is reasonably likely to disrupt the collection of information. NIH is requesting OMB approval by January 24, 2005, in order to be able to receive applications from scientific investigators that have been in preparation and development for many months in the expectation of support under the announced due dates of the RAID programs. Delay or deferral will create disruption of on going investigations and delay scientific advances. Proposed Collection: Title: ``Rapid Access to Interventional Development.'' The NCI RAID program receives between 30-40 applications yearly. R*A*N*D receives 8-10 applications yearly. IIP receives 10-15 applications yearly. Technology transfer information2 hours per application, completed by technology transfer specialist. Letters of commitment0.5 hours per application, completed by institutional head of clinical research. Application30-40 hours per application, completed by Ph.D., or M.D., Ph.D., level scientist. Other RAID type programs accept about 10-12 applications; however, the length of the material requested is somewhat shorter than the NCI Raid programs. The proposed NIH director's Roadmap Initiative anticipates 20-30 applications in the initial round. The total annual burden anticipated for the receipt dates for this emergency clearance request is estimated to be 4000 hours. A subsequent regular request for approval of the continuing collection will address the future estimated annual burden. The cost to the respondents based on the 4000 hour burden will be approximately $250,000. 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time should be directed to the Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Mr. Joe Ellis, Division of Grants Policy, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3513, 6705 Rockledge Drive, Bethesda, MD 20892-7974, or call non-toll-free number (301) 435-0935, or e-mail your request, including your address to: ellisj@od.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to add a new system of records. The new system of records, ``State-Provided Physician Records for the Application Submission & Processing System, SDB, BHPr, HRSA,'' will cover health care practitioners who are the subjects of databases collected and maintained by State Primary Care Offices/Associations. Such health care practitioners include physicians (both M.D.s and D.O.s), licensed or otherwise authorized by a State to provide health care services. This system of records is required to comply with the implementation directives of the Act, Public Law 108-20. The records will be used to support the Application Submission and Processing System electronic application for the development, submission, and review of applications for HPSAs and MUPs. The most critical requirement for accurate designation determinations is accurate data on the location of primary care providers relative to the population. To this end, SDB continually tries to obtain the latest data on primary care providers and their practice location(s) at the lowest geographical level possible for use in the designation process, with the objective of minimizing the level of effort required on the part of States and communities seeking designations.

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 requirements for assessing the antimicrobial resistance concerns as part of the overall preapproval safety evaluation of new animal drugs, focusing on the effect of antimicrobial new animal drugs on bacteria of human health concern.

The Food and Drug Administration (FDA) is proposing to amend the tentative final monograph (TFM) for over-the-counter (OTC) orally administered drug products for relief of symptoms associated with overindulgence in food and drink to include an additional use for products that contain bismuth subsalicylate as an active ingredient labeled for the relief of symptoms of upset stomach due to overindulgence resulting from food and drink. This proposal is part of FDA's ongoing review of OTC drug products.

The Food and Drug Administration (FDA) is reopening until February 18, 2005, the comment periods for the draft guidances entitled ``E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs'' and ``S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals.'' The draft guidances were prepared under the auspices of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. FDA published notices of availability of the draft guidances in the Federal Register of September 13, 2004 (69 FR 55163 and 69 FR 55164, respectively). FDA is taking this action in response to requests to extend the comment periods for both draft guidances.

Consistent with the Department of Health and Human Services management objectives, the Substance Abuse and Mental Health Services Administration (SAMHSA) announces a change in its practice of publishing notices of grant funding availability in the Federal Register. Rather than continue publishing NOFAs and RFAs in the Federal Register, SAMHSA will instead post notices of funding availability only on https://www.Grants.gov and https://www.samhsa.gov. Only single source or limited competition announcements will continue to be published in the Federal Register. This change will be effective January 3, 2005. Applicants should be aware that all the necessary information to apply for grant funds will continue to be available at SAMHSA's two national clearinghouses: The National Clearinghouse for Alcohol and Drug Information (NCADI)1-800-729-6686for substance abuse prevention or treatment grants; and the National Mental Health Information Center1-800-789-CMHS (2647)for mental health grants.