Department of Health and Human Services January 2006 – Federal Register Recent Federal Regulation Documents

The National Health and Nutrition Examination Survey (NHANES) is a program of periodic surveys conducted by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC). Examination surveys conducted since 1960 by NCHS have provided national estimates of the health and nutritional status of the U.S. civilian non-institutionalized population. To add to the large amount of information collected for the purpose of describing the health of the population, blood lymphocytes were collected in NHANES III in anticipation of advances in genetic research. The lymphocytes have been stored and maintained at the Division of Laboratory Sciences (DLS) at the National Center for Environmental Health (NCEH), CDC. The collection of lymphocytes was begun in the second phase of the survey (1991-1994) because of the significant advances in the rapidly evolving field of molecular biology that were occurring during the planning phase of this survey. CDC is making DNA samples from these specimens available to the research community for genetic analyses. Specimens are available from approximately 7,159 participants in the second phase of NHANES III. No cell lines will be made available. This program has been previously announced (Tuesday, June 1, 1999 [64 FR 29321]; Thursday, August 8, 2002 [67 FR 51585]). The purpose of this notice is to announce a fourth category for proposals for use of these specimens, add an additional secondary review of approved applications and provide a new proposal schedule. For final proposal guidelines and requests or letters of intent, please contact Ms. Oraegbu or go to https://www.cdc.gov/nchs/about/major/nhanes/ dnafnlgm2.htm. All interested researchers are encouraged to submit letters of intent. No funding is provided as part of this solicitation. Proposals will be reviewed by a technical panel and approved applications will be reviewed by an internal Secondary Review Committee, which will perform a programmatic review based on the results of the peer review for technical merit. The primary purpose of the Secondary Review Committee is to factor in the scientific and technical results from the first level of review, important programmatic considerations such as program priorities, program relevance, and other criteria germane to this announcement and to CDC. The secondary review panel will be comprised of senior CDC scientists, who will advise the Director, NCHS, on the approved applications. Projects approved by both reviews will be submitted to the NCHS Ethics Review Board for final approval. Approved projects that do not obtain funding on their own will be canceled. A more complete description of this program follows.

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for administrative law judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustments to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2006. The 2006 AIC threshold amounts are $110 for ALJ hearings and $1090 for judicial review.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP.'' The guidance describes a formal, two-tiered dispute resolution process intended to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP) that arise during FDA inspections of pharmaceutical manufacturers.

The Food and Drug Administration (FDA) is announcing its determination that two drug productsCelestone Soluspan (betamethasone sodium phosphate and betamethasone acetate) injection and Celestone (betamethasone sodium phosphate) injectionwere not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for betamethasone sodium phosphate and betamethasone acetate injection and betamethasone sodium phosphate injection if all other legal and regulatory requirements are met. However, in considering whether to file an ANDA for betamethasone sodium phosphate and betamethasone acetate injection, future applicants are advised that Celestone Soluspan injection may not be commercially available because, under a consent decree between FDA and the manufacturer, it is being made available in certain instances of medical necessity only. The reasons for its unavailability are not safety or effectiveness considerations associated with the drug product in general, but specific to the manufacturer. An ANDA applicant who is unable to obtain Celestone Soluspan injection for bioequivalence testing must contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and same therapeutic effect. If the reference listed drug (RLD) product becomes commercially available prior to ANDA approval, the ANDA applicant will need to show bioequivalence to the RLD product.

The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its twenty-third meeting, at which, among other things, it will continue the discussion on ethical issues relating to children. Subjects discussed at past Council meetings (though not on the agenda for the present one) include: Cloning, assisted reproduction, reproductive genetics, IVF, ICSI, PGD, sex selection, inheritable genetic modification, patentability of human organisms, neuroscience, aging retardation, lifespan-extension, and organ procurement for transplantation. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005).

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the United States Food and Drug Administration, Department of Health and Human Services and the Australian Pesticides and Veterinary Medicines Authority (APVMA), Australia. This MOU is intended to establish an information-sharing arrangement between APVMA and FDA. The Participants intend to strengthen the exchange of knowledge and expertise to enhance the efficiency and effectiveness of their respective roles. This MOU focuses on cooperation in relations to the operational aspects of animal drug regulation and is not intended to cover broader government regulatory policy or to cover areas not falling under the common jurisdictional purview of the Participants.

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 Bayer HealthCare LLC. The supplemental NADA provides for veterinary prescription use of a hyaluronate sodium solution, formulated with a benzyl alcohol preservative, for intravenous administration to horses for the treatment of osteoarthritis.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study of Carbohydrate Content Claims on Food Labels'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability for comments of a draft revised guidance for industry (93) entitled ``Impurities in New Veterinary Medicinal Products (Revised)'' VICH GL11(R). This draft revised guidance, which updates a final guidance on the same topic for which a notice of availability was published in the Federal Register of July 7, 2000 (the 2000 guidance), has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft revised document is intended to assist in developing registration applications for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States. The revised guidance addresses only those impurities in new veterinary medicinal drug products classified as degradation products.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). FDA believes, and is preparing a guidance document explaining, that it is possible in certain circumstances for In Vitro Diagnostic (IVD) device studies to be conducted using leftover specimens obtained without informed consent while protecting the human subjects who are the source of such specimens. This notice solicits comments on the proposed collection of information associated with the guidance document entitled ``Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable.''

The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry (166) entitled ``Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP's)Phase II'' (VICH GL38). This guidance has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document provides recommendations for internationally harmonized test methods used to generate environmental fate and toxicity data.

The Food and Drug Administration (FDA) is proposing to reclassify herpes simplex virus (HSV) (types 1 and/or 2) serological assays from class III (premarket approval) to class II (special controls). HSV serological assays (types 1 and/or 2) are intended for testing specimens from individuals who have signs and symptoms of infection consistent with HSV 1 and/or 2 or for determining if an individual has been previously infected with HSV 1 and/or 2, as well as for providing epidemiological information about these infections. The detection of HSV antibodies, in conjunction with other clinical laboratory findings, aids in the clinical laboratory diagnosis of an infection by HSV 1 and/or 2. FDA is proposing this reclassification on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance document that would serve as the special control, if FDA reclassifies this device.