OMB control number
Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling
OMB 0910-0624 · HHS/FDA.
OMB 0910-0624
This information collection supports Food and Drug Administration (FDA) regulations. Specifically, regulations found at 21 CFR 201.57 governing the content and format of labeling requirements for “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential” individuals. The regulations are intended to improve the content and format of prescription drug labeling by creating a consistent format for providing information about the risks and benefits of drug use during pregnancy and lactation by patients included within specific populations. The regulations also require the removal of the pregnancy categories A, B, C, D, and X from all drug product labeling.
The latest form for Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling expires 2021-04-30 and is listed under ICR 201802-0910-006.
Latest Forms, Documents, and Supporting Material
0624 Pregnancy Lactation Labeling SSA 2018 Ext.pdf
New NDAs/ANDAs/BLAs/Efficacy Supplements Submitted on or After Effective Date, Including Amendments to Applications Pending on Effective DateAll Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 201802-0910-006 | Extension without change of a currently approved collection | 2018-02-27 | Approved without change | |
| 201412-0910-008 | New collection (Request for a new OMB Control Number) | 2014-12-11 | Approved without change | |
| 200806-0910-002 | New collection (Request for a new OMB Control Number) | 2008-06-05 | Comment filed on proposed rule |
OMB Details
Supplements to Applications Approved 6/30/01 to Effective Date
Federal Enterprise Architecture: Health - Public Health Monitoring