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

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration.'' This guidance, when finalized, will provide industry with information on how to label beers that are subject to FDA's labeling laws and regulations. This draft guidance is being issued in light of the recent ruling by the Alcohol and Tobacco Tax and Trade Bureau (TTB) (formerly The Bureau of Alcohol, Tobacco, and Firearms (ATF)) clarifying that certain beers do not meet the definition of a ``malt beverage'' under the Federal Alcohol Administration Act (FAA Act). Because these beers are not subject to the labeling provisions of the FAA Act, they are subject to the labeling provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). FDA, in this draft guidance, also reminds manufacturers that the labeling of wine beverages containing less than 7 percent alcohol by volume, such as wine coolers, diluted wine beverages, dealcoholized or partially dealcoholized wine and ciders, is also subject to FDA labeling requirements. FDA is also announcing an opportunity for public comment on the proposed collection of certain information by the agency.

The Department of Health and Human Services (HHS) published a document in the Federal Register of July 17, 2009, requesting OMB reauthorization of the form ``Sterilization of Persons in Federally Assisted Family Planning Projects.'' The document contained an incorrect citation to the HHS sterilization regulations; incorrectly identified the Office of Population Affairs (OPA), rather than the Public Health Service (PHS), as the agency within HHS that administers programs of health services which are supported by Federal financial assistance and which are required to obtain informed consent from persons undergoing sterilizations; incorrectly described the form that is required to be used to obtain informed consent; and incorrectly referred to the regulations to which the consent form is appended as OPA regulations rather than PHS regulations.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 10: Polyacrylamide Gel Electrophoresis General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Polyacrylamide Gel Electrophoresis General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft 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. This draft guidance is the tenth annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).

This proposed rule sets forth an update to the Home Health Prospective Payment System (HH PPS) rates; the national standardized 60-day episode rates, the national per-visit rates, the non-routine medical supply (NRS) conversion factor, and the low utilization payment amount (LUPA) add-on payment amount, under the Medicare prospective payment system for home health agencies effective January 1, 2010. In addition, this rule proposes a change to the HH PPS outlier policy and proposes to require the submission of OASIS data as a condition for payment under the HH PPS. Also, this rule proposes payment safeguards that would improve our enrollment process, improve the quality of care that Medicare beneficiaries receive from HHAs, and reduce the Medicare program's vulnerability to fraud. This rule also proposes clarifying language to the ``skilled services'' section and Condition of Participation (CoP) section of our regulations. This proposed rule also clarifies the coverage of routine medical supplies under the HH PPS. We are also soliciting comments on: Physician/patient interaction associated with the home health plan of care (POC); a Consumer Assessment of Healthcare Providers and Systems (CAHPS) Home Health Care Survey; the Outcome and Assessment Information Set (OASIS), Version C, effective January 1, 2010; proposed pay for reporting measures for use in CY 2011; and a number of minor payment-related issues. We are also responding to comments received as a result of our solicitation in the CY 2008 HH PPS final rule with comment period.

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 Pennfield Oil Co. The supplemental NADA provides for the use of fixed-combination Type A medicated articles containing oxytetracycline and neomycin sulfate to formulate two-way, fixed-combination drug Type B and Type C medicated feeds for chickens, turkeys, swine, cattle, and sheep. This approval reflects FDA's effectiveness conclusions which relied on the National Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy Study Group's evaluation of the effectiveness of these drugs when used in animal feed as single ingredients.

The Food and Drug Administration (FDA) is amending its regulations on access to investigational new drugs for the treatment of patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use is available to individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The final rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies. Elsewhere in this issue of the Federal Register, FDA is publishing the final rule on Charging for Investigational Drugs Under an Investigational New Drug Application which clarifies the circumstances in which charging for an investigational drug in a clinical trial is appropriate, sets forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in this final rule, and clarifies what costs can be recovered for an investigational drug.

The NTP invites public comment on the recommendations from an expert panel on the listing status for glass wool fibers in the 12th RoC and the scientific justification for the recommendations. The recommendations and scientific justification are available electronically in part B of the Expert Panel Report (https:// ntp.niehs.nih.gov/go/29682) or in printed text from the RoC Center (see ``FOR FURTHER INFORMATION CONTACT'' below). The RoC Center convened a nine-member, scientific expert panel on June 9-10, 2009, that was charged (1) To apply the RoC listing criteria to the relevant scientific evidence for glass wool fibers and make a recommendation regarding its listing status (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) in the 12th RoC and (2) to provide a scientific justification for the recommendation.

The Food and Drug Administration (FDA) has determined the regulatory review period for NPLATE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.

The U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) Medical Countermeasure Markets and Sustainability Working Group is requesting public comment to their working document, ``Inventory of Issues Constraining or Enabling Industry Involvement in Medical Countermeasure Efforts''. The inventory (or grid) includes factors that may discourage industry involvement or partnering with the U.S. Government in medical countermeasure development efforts, reported constraints to industry involvement, and potential solutions for relief from a particular constraint. The inventory has been catalogued by financial, legislative, scientific, human capital, regulatory, and societal elements. The Working Group wishes to solicit comment, feedback, and guidance from members of industry, other government agencies, and the public at large for consideration by the Working Group to strengthen and refine the document prior to its public presentation to the NBSB at the scheduled Fall 2009 public meeting of the Board.