Department of Health and Human Services December 20, 2012 – Federal Register Recent Federal Regulation Documents

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at 301-443-1984.

The Food and Drug Administration (FDA) is announcing the availability of two guidances for industry and investigators entitled ``Safety Reporting Requirements for INDs and BA/BE Studies'' and ``Safety Reporting Requirements for INDs and BA/BE StudiesSmall Entity Compliance Guide.'' These guidances are intended to help sponsors and investigators comply with the requirements in the final rule entitled ``Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans,'' published in the Federal Register on September 29, 2010 (75 FR 59935). FDA has prepared the Small Entity Compliance Guide in accordance with the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses understand and comply with the regulations issued by FDA concerning safety reporting requirements for investigational new drug applications (IND) and bioavailability (BA) and bioequivalence (BE) studies.