Draft Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act

ICR 201212-0910-007

OMB: 0910-0705

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2012-12-12
Justification for No Material/Nonsubstantive Change
2012-12-12
IC Document Collections
IC ID
Document
Title
Status
197892 Modified
ICR Details
0910-0705 201212-0910-007
Historical Active 201105-0910-007
HHS/FDA
Draft Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 12/19/2012
Retrieve Notice of Action (NOA) 12/13/2012
Previous terms of clearance apply: In accordance with the terms of 5 CFR 1320, OMB approves this ICR for a period of three years. If FDA requests an extension of this approval,FDA should make significant progress in making an electronic submission available. If electronic submission is not available, the agency should submit a timeline for implementation and report on progress.
  Inventory as of this Action Requested Previously Approved
03/31/2015 03/31/2015 03/31/2015
114 0 114
1,368 0 1,368
0 0 0

Section 513 of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the act) (21 U.S.C. 360c, et seq.) provides for the classification of devices intended for human use. Under section 513(a), devices are classified by the regulatory controls needed to provide reasonable assurance of their safety and effectiveness into class I (general controls), class II (special controls), or class III (premarket approval). Section 513(g) provides a means of obtaining information from FDA regarding the classification and regulatory requirements that may be applicable to a particular device; specifically, that within 60 days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under the act, the Secretary of Health and Human Services shall provide such person a written statement of the classification (if any) of such device and the requirements of this act applicable to the device.

US Code: 21 USC 360c Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

No

1
IC Title Form No. Form Name
FD&C Act 513(g)

  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 114 114 0 0 0 0
Annual Time Burden (Hours) 1,368 1,368 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$176,472
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov

  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:
 
 
 
 
 
 
 
    (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.
12/13/2012


© 2024 OMB.report | Privacy Policy