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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0624 Pregnancy Lactation Labeling SSA 2018 Ext.pdf	Supporting Statement A	Uploaded 2018-02-26	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
185245	New NDAs/ANDAs/BLAs/Efficacy Supplements Submitted on or After Effective Date, Including Amendments to Applications Pending on Effective Date		Modified
185244	Annual Report Submission of Revised Labeling for Applications Approved Before 6/30/01 that Contain a Pregnancy Category		Modified
185243	Supplements to Applications Approved 6/30/01 to Effective Date		Modified

ICR Details

OMB Control No: 0910-0624	ICR Reference No: 201802-0910-006
Status: Active	Previous ICR Reference No: 201412-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/27/2018
	Date Received in OIRA: 02/27/2018
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2021	36 Months From Approved	04/30/2018
Responses	19,480	0	19,480
Time Burden (Hours)	1,590,400	0	1,590,400
Cost Burden (Dollars)	0	0	0

---

Abstract: 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.

---

Authorizing Statute(s): 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
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 46248	10/04/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 6036	02/12/2018
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
New NDAs/ANDAs/BLAs/Efficacy Supplements Submitted on or After Effective Date, Including Amendments to Applications Pending on Effective Date
Supplements to Applications Approved 6/30/01 to Effective Date
Annual Report Submission of Revised Labeling for Applications Approved Before 6/30/01 that Contain a Pregnancy Category

---

ICR Summary of Burden

table that charts list of burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

---

Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 02/27/2018

---