Department of Health and Human Services January 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by First Priority, Inc. The supplemental application provides for revising the description of a 1-gram oral dosage form of phenylbutazone from tablet to bolus.

This proposed rule would make regulatory revisions based on a change in our interpretation of section 1860D-22(b) of the Social Security Act. We would interpret this provision as providing us with the authority to ``waive or modify'' statutory requirements pertaining to the Retiree Drug Subsidy (RDS) program in order to facilitate the offering of a prescription drug plan covering employees or retirees.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Test for Particulate Contamination: Subvisible Particles General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.''

This notice announces the final priority data needs for two priority hazardous substances (see Table 1) as part of the continuing development and implementation of the ATSDR Substance-Specific Applied Research Program (SSARP). The notice also serves as a continuous call for voluntary research proposals. The exposure and toxicity priority data needs in this notice were distilled from the data needs identified in ATSDR's toxicological profiles by the logical scientific approach described in a decision guide published in the Federal Register on September 11, 1989 (54 FR 37618). The priority data needs represent essential information to improve the database for conducting public health assessments. Research to address these priority data needs will help to determine the types or levels of exposure that may present significant risks of adverse health effects in people exposed to the hazardous substances. The priority data needs announced in this notice reflect the opinion of ATSDR, in consultation with other federal programs, about the research needed pursuant to ATSDR's authority under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (Superfund), or CERCLA, as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9604(i)]. The needs identified here do not represent the priority data needs for any other agency or program. Consistent with section 104(i)(12) of CERCLA as amended [42 U.S.C. 9604(i)(12)], nothing in this research program shall be construed to delay or otherwise affect or impair the President, the Administrator of ATSDR, or the Administrator of the Environmental Protection Agency (EPA) from exercising any authority regarding any other provision of law, including the Toxic Substances Control Act of 1976 (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act of 1972 (FIFRA), or the response and abatement authorities of CERCLA. ATSDR worked with other federal programs to determine common substance-specific data needs and mechanisms to implement research that may include authorities under TSCA and FIFRA, private-sector voluntarism, or the direct use of CERCLA funds. Table 1 presents the priority data needs for acrolein and barium, two priority substances included in the ATSDR Priority List of Hazardous Substances (73 FR 12178, March 6, 2008). These priority data needs were initially announced by ATSDR in the Federal Register on September 8, 2006 (71 FR 53102). The public was invited to comment on these data needs for these two substances during a 90-day period. No public comments were received. These priority data needs and accompanying documents were reviewed by EPA and the National Institute of Environmental Health Sciences (NIEHS), and will be addressed by the mechanisms described in the ``Implementation of Substance-Specific Applied Research Program'' section of this Federal Register Notice.

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 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.

This notice amends the uniform protocol for the analysis of nicotine, total moisture, and pH in smokeless tobacco products (``Protocol''). The Protocol, originally published in the Federal Register in 1999 (64 FR 14086) and revised in the Federal Register on March 14, 2008 (73 FR 13903), implements the requirement of the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA) of 1986 (15 U.S.C. 4401 et seq., Pub. L. 99-252) that each person manufacturing, packaging, or importing smokeless tobacco products shall annually provide the Secretary of Health and Human Services (HHS) with a specification of the quantity of nicotine contained in each smokeless tobacco product. CDC re-published the notice in the Federal Register on June 23, 2008 (73 FR 35395) concerning the revision of the Protocol (1) To make a technical change to correct the date when the first report of information under the revised Protocol is due and (2) to solicit public comments concerning a change in the Protocol that increased the volume of water in the pH determination from 10 mL to 20 mL, and (3) to solicit public comments concerning the addition of the following commercial smokeless tobacco product categories: dry snuff portion packs, snus, snus portion packs, and pellet or compressed. This Notice also includes a summary of public comments and CDC's response to them. The Protocol as published in the Federal Register on March 14, 2008 (73 FR 13903), remains in effect with the technical correction to the date as described in the Federal Register notice published on June 23, 2008 (73 FR 35395).

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Library of Medicine (NLM), 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 October 8, 2008 (Vol. 73, No. 196, p. 58973) and allowed 60 days for public comment. One public comment was 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: Information Program on Clinical Trials: Maintaining a Registry and Results Databank; Type of Information Collection Request: Revision of currently approved collection [OMB No. 0925-0586, expiration date 01/31/2009], Form Number: N/A; Need and Use of Information Collection: The National Institutes of Health is modifying the clinical trial registry databank established under previous law [FDAMA, Section 113] to comply with provisions of Title VIII of Public Law 110-85 (Food and Drug Administration Amendments Act of 2007). The databank collects specified registration and results information on certain clinical trials identified in the law, with the objective of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical trials, to the benefit of public health. The databank is widely used by patients, physicians, and medical researchers; in particular, those involved in clinical research studies. Public Law 110-85 expands the scope of clinical trials that must be registered in ClinicalTrials.gov, increases the clinical trial information that must be submitted as part of each registration, and requires the submission of basic results information for registered trials of approved drugs, biologics and devices. Frequency of Response: Responsible parties must submit the required registration information not later than 21 days after enrolling the first subject. Results information is to be reported not later than 12 months after the completion date (as defined in the law), but the responsible party may request an extension of the deadline or delay submission by certifying that the drug or device under study has not yet been approved. Updates to submitted information are required at least once a year, unless there are no changes to report. Changes in recruitment status and completion of a trial must be reported not later than 30 days after such events. Description of Respondents: Respondents are referred to in the law as ``responsible parties,'' and are defined as: (1) The sponsor of the clinical trial (as defined in 21 CFR 50.3) or (2) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, provided that ``the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements'' for submitting information under the law. Estimate of Burden: The burden associated with this information collection consists of two parts: the burden associated with registration of clinical trials; and the burden associated with the reporting of results information. In both cases, the burden includes the time necessary to extract information from the study protocol or results record, reformat and review it, enter it into the databank, and provide necessary updating over the course of the study. It is estimated that registration information will be required for 3,000 trials of drugs and biologics and 445 trials of medical devices each year. Each initial registration is estimated to take 7 hours and each of the subsequent 8 updates to the record are estimated to take 2 hours, resulting in an annual burden of 79,235 hours. It is estimated that there will be voluntary submissions of registration information for 6,000 trials of drugs and biologics, 545 trials of devices, and 5,280 trials of other types of medical interventions. Using the same hour estimates as for mandatory registration, the burden associated with voluntary registrations is estimated at 271,975 hours, bringing the total registration burden to 351,210 hours. In the first year of operation, it is estimated that there will be an additional burden of 84,150 hours associated with the updating of information for 7,000 trials of drugs and biologics and 650 trials of medical devices that were previously registered in the databank and ongoing as of December 26, 2007 (90 days after enactment). It is estimated that such trials will require one update of 3 hours to bring them into compliance with the new law (FDAAA) and 4 subsequent updates of 2 hours each. Submisson of results information is required only for those applicable clinical trials of drugs, biologics, and devices that are subject to the mandatory registration requirements of FDAAA and for which the product(s) under study have been approved or cleared by the FDA. It is estimated that results reporting will be required for 1,645 trials of drugs and biologics and 375 trials of medical devices each year. Initial submission of results information is estimated to require 10 hours, and each result submission is expected to require two updates that take 5 hours each. It is estimated that 2,345 trials per year will submit certifications for delayed reporting of results information or a request for an extension of the reporting deadline. Preparation and submission of such information is estimated to take 1 hour. The total burden for results reporting is therefore estimated at 42,745 hours per year. There are no capital costs to report. The operating and maintenance budget for the Clinical Trials Registry Databank in FY2009 is projected to be approximately $3 million. Request For Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and clarity of the information to be collected; and (4) 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, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, 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: David Sharlip, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll free number 301-402-9680 or e-mail your request to sharlipd@mail.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.

HRSA will be providing temporary critical HIV medical care and treatment services through the Medical Center of Louisiana at New Orleans to avoid a disruption of HIV clinical care to clients in Orleans Parish in Louisiana.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Labeling OTC Human Drug ProductsQuestions and Answers.'' This guidance is intended to assist manufacturers, packers, and distributors of over-the-counter (OTC) drug products in complying with the agency's regulation on standardized content and format requirements for the labeling of OTC drug products. This guidance primarily discusses labeling questions that have been frequently asked by manufacturers, packers, and distributors relating to these requirements. The labeling examples in this guidance show various format and content features and suggest how OTC drug monograph labeling information finalized before the new requirements can be converted to the new format. This guidance finalizes the draft guidance of the same name published January 13, 2005 (70 FR 2415).