The Paperwork Reduction Act of 1995 Sample Clauses

The Paperwork Reduction Act of 1995. This draft guidance includes information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520). The collections of information referenced in this draft guidance that are related to the burden on the submission of investigational new drug applications are covered under 21 CFR Part 312, including plans for pediatric studies under 21 CFR 312.47(b)(1)(iv) and waiver requests under 21 CFR 312.10, and have been approved under OMB control number 0910–0014. The collections of information referenced in this draft guidance that are related to the burden on the submission of new drug applications are covered under 21 CFR Part 314, including pediatric use information under 21 CFR 314.50(d)(7) and waiver requests under 21 CFR 314.90, and have been approved under OMB control number 0910–0001. The collections of information referenced in this draft guidance that are related to the burden on the submission of biologic license applications are covered under 21 CFR Part 601, including pediatric use information and waiver requests under 21 CFR 601.27, and have been approved under OMB control number 0910–0338. Sponsors are already required to submit plans for pediatric studies and often provide the information outlined in this guidance pursuant to the regulations noted above. The new FDASIA provisions primarily serve to establish a more precise timeline for the submission of that information; guidance that may be considered new or that would represent material modifications to those previously approved collections of information found in FDA regulations or guidances.