2017-08305. Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Blood Establishment Registration and ...
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Start Preamble
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing that two collections of information: “Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution” and “Blood Establishment Registration and Product Listing” have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
On December 16, 2016, the Agency submitted proposed collections of information entitled “Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution” and “Blood Establishment Registration and Product Listing” to Start Printed Page 19059OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control numbers 0910-0045 and 0910-0052, respectively. The information collection 0910-0045 expires on December 31, 2018, and the information collection 0910-0052 expires May 31, 2018. Copies of the supporting statements for the information collections are available on the Internet at http://www.reginfo.gov/public/do/PRAMain.
Start SignatureDated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08305 Filed 4-24-17; 8:45 am]
BILLING CODE 4164-01-P
Document Information
- Published:
- 04/25/2017
- Department:
- Food and Drug Administration
- Entry Type:
- Notice
- Action:
- Notice.
- Document Number:
- 2017-08305
- Pages:
- 19058-19059 (2 pages)
- Docket Numbers:
- Docket No. FDA-2005-N-0464 (Formerly Docket No. 2005N-0403)
- PDF File:
- 2017-08305.pdf
- Supporting Documents:
- » Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Blood Establishment Registration and Product Listing
- » Tab 5: Cost Impacts of the Over-the-Counter Pharmaceutical Labeling Rule - 03/05/1999 final report
- » Tab 3: Draft Final Economic Impact Analysis for a Prospective FDA Rule Governing: Foreign and Domestic Establishment Registration and Listing Requirements for Human Drugs, Certain Biological Drugs, and Animal Drugs - on 08/03/2005
- » Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction
- » Ref2_ERG Revisions 1995 DRAFT FINAL REPORT ECONOMIC THRESHOLD AND REGULATORY FLEXIBILITY ASSESSMENT OF PROPOSED CHANGES TO THE CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS FOR MANUFACTURING, PROCESSING, PACKING, OR HOLDING DRUGS (21CFR210&211) re Requi
- » Ref1_BLS_wages_May_2014_NAICS325400 - Pharmaceutical and Medicine Manufacturing re Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and
- » Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that Are Regulated Under a Biologics License Application, and Animal Drugs
- » Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs
- » Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing; Availability
- » Guideline re Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing; Availability