Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling

ICR 201802-0910-006

OMB: 0910-0624

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0624 201802-0910-006
Active 201412-0910-008
Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling
Extension without change of a currently approved collection   No
Approved without change 04/27/2018
Retrieve Notice of Action (NOA) 02/27/2018
  Inventory as of this Action Requested Previously Approved
04/30/2021 36 Months From Approved 04/30/2018
19,480 0 19,480
1,590,400 0 1,590,400
0 0 0

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.

US Code: 42 USC 262 Name of Law: Public Health Service Act
   US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act

Not associated with rulemaking

  82 FR 46248 10/04/2017
83 FR 6036 02/12/2018

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 19,480 19,480 0 0 0 0
Annual Time Burden (Hours) 1,590,400 1,590,400 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0

Domini Bean 301 796-5733 [email protected]


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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