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

The Food and Drug Administration (FDA) is issuing an order requiring manufacturers of remaining preamendments class III devices for which regulations requiring submission of premarket approval applications (PMAs) have not been issued to submit to FDA a summary of, and a citation to, any information known or otherwise available to them respecting such devices, including adverse safety or effectiveness information concerning the devices which has not been submitted under the Federal Food, Drug, and Cosmetic Act (the act). FDA is requiring the submission of this information in order to determine, for each device, whether the classification of the device should be revised to require the submission of a PMA or a notice of completion of a Product Development Protocol (PDP), or whether the device should be reclassified into class I or II.

Notice is hereby given that the Administration for Children and Families (ACF), Office of Community Services (OCS) will award a non-competitive successor grant to Neighborhood Assets, a non-profit organization located in Spokane, Washington. The Assets for Independence program supports grantees that provide low-income individuals and families with access to special matched savings accounts called individual development accounts (IDAs) and other asset- building tools such as financial literacy education and coaching and training on money management and consumer issues. The award will enable the Neighborhood Assets to implement an Assets for Independence project serving low-income families in Spokane, Washington. This action is taken as the original grantee, Spokane Neighborhood Action Programs, has relinquished the grant.

The Administration on Aging (AoA) 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 information collection requirements relating to Performance Reports for Title VI grantees.

HRSA will be transferring Part C funds to Saint Michael's Medical Center as a noncompetitive replacement award in order to ensure continuity of critical HIV medical care and treatment services and to avoid a disruption of HIV clinical care to clients in Metropolitan Newark, and Essex County in New Jersey.

The Centers for Disease Control and Prevention (CDC) is seeking public comment on a set of proposed criteria to be used in determining which vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) for the general United States population should be required for immigrants seeking admission into the United States or seeking adjustment of status to that of an alien lawfully admitted for permanent residence. Under section 212 of the Immigration and Nationality Act (INA) (8 U.S.C. 1182), an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, must present documentation for having received vaccination for ``vaccine-preventable diseases, which shall include at least the following diseases: mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus influenzae type B and hepatitis B, and any other vaccinations against vaccine-preventable diseases recommended by the Advisory Committee on Immunization Practices.'' Because the INA explicitly requires vaccinations for some vaccine-preventable diseases (mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus influenzae type B and hepatitis B), CDC will continue to require those vaccinations for immigrants seeking admission into the United States or seeking to adjust their status to that of legal permanent resident. CDC has developed specific criteria to determine which other vaccinations recommended by ACIP for the general population will be required for such immigrants. Through this notice, CDC proposes to begin use of the following criteria:

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 4C: Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use 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 Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use 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.''

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 collection of information entitled ``Voluntary Cosmetic Registration Program'' 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 of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4B: Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms 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 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms 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.''

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a guidance document entitled, ``Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards.'' The guidance document provides OHRP's first formal guidance on this topic. The document, which is available on the OHRP Web site at https://www.hhs.gov/ohrp/humansubjects/guidance/gina.html and https://www.hhs.gov/ohrp/humansubjects/guidance/gina.pdf, is intended primarily for investigators who conduct, and institutional review boards (IRB) that review, non-exempt human subjects research involving genetic testing or collection of genetic information (hereinafter referred to as ``genetic research''). The guidance document provides background on protections provided by the Genetic Information Nondiscrimination Act of 2008 (GINA) and discusses some of the implications of GINA for investigators who conduct, and IRBs that review, genetic research, particularly with respect to the criteria for IRB approval of research and the requirements for obtaining informed consent under the Department of Health and Human Services (HHS) regulations for the protection of human subjects (45 CFR part 46).

As part of our ongoing review of over-the-counter (OTC) drug products, we (Food and Drug Administration (FDA)) are announcing a call-for-data for safety and effectiveness information for sodium shale oil sulfonate (SSOS), 0.5 to 2.0 percent, as a rinse-off treatment for dandruff. We have reviewed a time and extent application (TEA) for SSOS and determined that it is eligible for consideration in our OTC drug monograph system. We will evaluate the submitted data and information to determine whether SSOS can be generally recognized as safe and effective (GRASE) as an OTC rinse-off treatment for dandruff.