Department of Health and Human Services June 29, 2011 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. This proposed information collection was previously published in the Federal Register on April 27, 2011, pages 23609-23611, and allowed 60 days for public comment. One written comment was received. The comment questioned the cost and utility of the study and federally funded biomedical research in general. The purpose of this notice is to allow an additional 30 days for public comment. Proposed Collection: Title: Biospecimen and Physical Measures Formative Research Methodology Studies for the National Children's Study (NCS). Type of Information Collection Request: Generic Clearance. Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q11 Development and Manufacture of Drug Substances.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use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 The draft guidance describes approaches to developing process and drug substance understanding and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The draft guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions.

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.