OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile

OMB 0910-0614 · HHS/FDA.

OMB 0910-0614

This information collection supports agency regulations pertaining to Exceptions or Alternatives to Labeling Requirements for Products Held By the Strategic National Stockpile (SNS). The regulations require certain reporting by respondents who make requests for such exceptions for alternatives. Requests granted under the regulations may include conditions or safeguards so that the labeling for such products includes appropriate information necessary for the safe and effective use of the product under its anticipated circumstances of use. This facilitates the safety, effectiveness, and availability of appropriate medical countermeasures in the event of a public health emergency.

The latest form for Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile expires 2023-12-31 and is listed under ICR 202010-0910-003.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
0614 SNS SSA 2020 Ext.docxSupporting Statement A
SNS Reporting: Changes or updates to previous submissions for labeling exceptions or alternatives Information collection
SNS Reporting: Requests for labeling exceptions or alternatives from applicable requirements Information collection

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202010-0910-003 Extension without change of a currently approved collection 2020-11-25 Approved without change
201706-0910-018 Extension without change of a currently approved collection 2017-08-18 Approved without change
201407-0910-011 Extension without change of a currently approved collection 2014-07-22 Approved without change
201104-0910-013 Extension without change of a currently approved collection 2011-04-29 Approved without change
200805-0910-006 Extension without change of a currently approved collection 2008-05-13 Approved without change
200805-0910-005 Revision of a currently approved collection 2008-05-13 Approved without change
200711-0910-007 New collection (Request for a new OMB Control Number) 2007-11-20 Preapproved

OMB Details

SNS Reporting: Requests for labeling exceptions or alternatives from applicable requirements

Federal Enterprise Architecture: Health - Consumer Health and Safety