Nutrition Labeling for Dietary Supplements -- 21 CFR Part 101 (Proposed Rule)

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Forms and supporting documents for this ICR

Document	Type	Status	Availability

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Information collection document groups

IC ID	Collection	Type	Status	Form
5884	Nutrition Labeling for Dietary Supplements -- 21 CFR Part 101 (Proposed Rule)		Migrated

ICR Details

OMB Control No:	ICR Reference No: 199601-0910-002
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Nutrition Labeling for Dietary Supplements -- 21 CFR Part 101 (Proposed Rule)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 03/06/1996
	Date Received in OIRA: 01/19/1996
Terms of Clearance: OMB does not approve this package. OMB is concerned about the accuracy of the cost and hour burden estimates, as well as the utility of the nutrition info. required to be disclosed on the labels of dietary supplements and whether the labels are sufficiently clear to the third-party recipients of this information. When the package is re-submitted to OMB for approval at the final stage, the agency will address OMB's concerns and the public comments received on these issues in the preamble of the final rule and in the paperwork submission package.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Manufacturers and other suppliers of dietary supplements are required by the Dietary Supplement Health and Education Act of 1994 to place nutrition information on the labels of their products. This proposal would amend 21 CFR 101.36 that requires that the label of a dietary supplement bear nutrition labeling.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Nutrition Labeling for Dietary Supplements -- 21 CFR Part 101 (Proposed Rule)

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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:

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Annual Cost to Federal Government: $0

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]? Uncollected

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)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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: 01/19/1996

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