Medical Device Labeling Regulations

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
OTC Hearing Aids FRIA 08-12-22.pdf	Supplementary Document	Uploaded 2022-08-17	Repair queued
0485 Hearing Aid FR RIN 0910-AI21 SSA 2022.docx	Supporting Statement A	Uploaded 2022-08-17	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
255349	OTC Hearing Aids Final Rule - New Requirements	Other-Agency Guidance	New
255348	OTC Hearing Aids Final Rule - One Time Burden		New
247934	Medical Device Labeling; Reporting		Removed
232983	Medical Device Labeling Regulations; Third-Party Disclosure	Other-Agency Guidance	Removed
232982	Medical Device Labeling Regulations; Recordkeeping		Removed

ICR Details

OMB Control No: 0910-0485	ICR Reference No: 202208-0910-007
Status: Historical Active	Previous ICR Reference No: 202108-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Device Labeling Regulations
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/17/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/18/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2025	36 Months From Approved	11/30/2024
Responses	2,625	0	103,559,804
Time Burden (Hours)	104,370	0	12,303,422
Cost Burden (Dollars)	10,100,000	0	0

---

Abstract: This information collection request supports rulemaking to establish an OTC category of hearing aid devices to enable these devices to become more accessible to American consumers.

---

Authorizing Statute(s): PL: Pub.L. 115 - 52 709 Name of Law: FDA Reauthorization Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AI21	Final or interim final rulemaking	87 FR 50698	08/17/2022

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Medical Device Labeling Regulations; Recordkeeping
Medical Device Labeling Regulations; Third-Party Disclosure
Medical Device Labeling; Reporting
OTC Hearing Aids Final Rule - New Requirements
OTC Hearing Aids Final Rule - One Time Burden

---

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	2,625	103,559,804	0	0	-103,557,179	0
Annual Time Burden (Hours)	104,370	12,303,422	0	0	-12,199,052	0
Annual Cost Burden (Dollars)	10,100,000	0	0	0	10,100,000	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: To reflect one-time burden respondents may incur adjusting to the new requirements, we have added 945 responses and 87,570 hours to our annualized estimate. To reflect recurring burden we attribute to maintaining compliance with the new requirements, we have added 1,680 responses and 16,800 hours annually. Cumulatively, these adjustments result in an increase of 2,625 responses and 104,370 hours annually to the information collection.

---

Annual Cost to Federal Government: $2,633,260

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? No

---

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: 08/18/2022

---