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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0664
ICR Reference No:
201007-0910-002
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Section 4205 of the Patient Protection and Affordable Care Act ( P.L. 111-148: Restaurant Menu Labeling : Registration For Small Chains
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Emergency
Approval Requested By:
07/20/2010
OIRA Conclusion Action:
Approved without change
Conclusion Date:
07/16/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/15/2010
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2011
6 Months From Approved
Responses
2,432
0
0
Time Burden (Hours)
1,755
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
In addition to restaurant menu and vending machine labeling, section 4205 of the " Affordable Care Act" provides that persons or firms not subject to the disclosure of nutrition information required by this legislation, such as chain restaurants with fewer than 20 locations or vending machine operators with fewer than 20 vencing machines may elect to be subject to the requirements provided under section 4205 by registering biannually with FDA. Under section 4205, FDA must publish notice in the FEDERAL REGISTER within 120 days of the date of enactment ot the legislation ( i.e. July 21, 2010), providing information on the terms and conditions for persons who voluntarily elect to be subject to nutition disclosue requirements specified in the legislation.
Emergency Justfication:
FDA is requesting emergency OMB approval of the voluntary registration procedures so that it can publish the required notice in the FEDERAL REGISTER by july 21, 2010. Among other things, under section 4205 of the " Affordable Care Act," FDA must publish notice in the FEDERAL REGISTER within 120 days of enactment of the legislation( i.e. July 21, 2010), providing information on terms and conditions for persons who voluntarily elect to be subject to nutrition disclosure requirements specified in the legislation. In a nutshell, this includes chain restaurants with fewer than 20 locations and or vending machine operators with fewer than 20 vending machines.
Authorizing Statute(s):
US Code:
21 USC 4205
Citations for New Statutory Requirements:
US Code: 21 USC 4205
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Other Documents for OIRA Review
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
6
IC Title
Form No.
Form Name
Reporting - New Registrations ( recurring)
3756
Reporting - Re- registrations ( recurring)
3756
Reporting : Registration for C-store ( initial)
3756
Reporting- Registration for Restaurants ( initial)
3756
Reporting: Registration for Grocery ( initial)
3756
Reporting: Registration for Other SRFE ( initial)
3756
ICR Summary 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
2,432
0
2,432
0
0
0
Annual Time Burden (Hours)
1,755
0
1,755
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:
There is a burden increase ( program change) due to implementation of the provisions of a new statue.
Annual Cost to Federal Government:
$260,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
Yes
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Denver Presley 3018271462
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:
07/15/2010
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