United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2011_register executive 2011-10-19 article Proposed Rules D09002ee1c7ff2683 D09002ee1c7ff2711 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is proposing to amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued. 76 FR 64868 https://www.govinfo.gov/app/details/FR-2011-10-19/2011-27037 2011-27037 fr19oc11-26 RIN 0910-AG72 4160-01-P Docket No. FDA-2011-N-0583 https://www.govinfo.gov/app/details/FR-2011-10-19/2011-27037 https://www.govinfo.gov/content/pkg/FR-2011-10-19/html/2011-27037.htm https://www.govinfo.gov/content/pkg/FR-2011-10-19/pdf/2011-27037.pdf Administrative Practice and Procedure Drugs Investigations Medical Research Orphan Drugs Reporting and Recordkeeping Requirements 12 p. 64868 64879 76 FR 64868 Title 21 Part 316 21 CFR Part 316 RIN 0910-AG72 Orphan Drug Regulations; Federal Register Vol. 76, Issue PRORULE 2011-27037 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2012-01-17 Docket No. FDA-2011-N-0583 4160-01-P 2011-27037 Proposed rule.

The Food and Drug Administration (FDA) is proposing to amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued.

Submit either electronic or written comments on the proposed rule by January 17, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by November 18, 2011 (see the "Paperwork Reduction Act of 1995" section of this document). Erica K. McNeilly, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5271, Silver Spring, MD 20993, 301-796-8660. Administrative Practice and Procedure Drugs Investigations Medical Research Orphan Drugs Reporting and Recordkeeping Requirements Orphan Drug Regulations , oira_submission@omb.eop.gov http://www.bls.gov/oes/current/naics4_325400.htm http://www.fda.gov/orphan/ http://www.regulations.gov http://www.sba.gov/sites/default/files/Size_Standards_Table.pdf Vol. 76, no. 202 Office of the Federal Register, National Archives and Records Administration 2011-10-19 continuing daily deposited born digital 322 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2011-10-19 P0b002ee180ea3497 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr19oc11 https://www.govinfo.gov/app/details/FR-2011-10-19 https://www.govinfo.gov/content/pkg/FR-2011-10-19/pdf/FR-2011-10-19.pdf https://www.govinfo.gov/content/pkg/FR-2011-10-19/xml/FR-2011-10-19.xml fdlp 64781 65093 DGPO 2011-10-19 2024-06-03 FR-2011-10-19 machine generated eng FR FR-2011-10-19 76 202