Document ID: FDA-2009-N-0221-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
Posted Date: 2009-06-02T04:00Z

[Federal Register: June 2, 2009 (Volume 74, Number 104)]
[Notices]               
[Page 26406-26407]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jn09-69]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0221]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Labeling; Notification Procedures for Statements 
on Dietary Supplements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
provisions of the regulation requiring manufacturers, packers, and 
distributors of dietary supplements to notify FDA that they are 
marketing a dietary supplement product that bears on its label or in 
its labeling a statement provided for in the Federal Food, Drug, and 
Cosmetic Act (the act).

DATES:  Submit written or electronic comments on the collection of 
information by August 3, 2009.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3794.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Food Labeling; Notification Procedures for Statements on Dietary 
Supplements--21 CFR 101.93 (OMB Control Number 0910-0331)--Extension

    Section 403(r)(6) of the act (21 U.S.C. 343(r)(6)) requires that 
the agency be notified by manufacturers, packers, and distributors of 
dietary supplements that they are marketing a dietary supplement 
product that bears on its label or in its labeling a statement provided 
for in section 403(r)(6). Section 403(r)(6) of the act requires that 
the agency be notified, with a submission about such statements, no 
later than 30 days after the first marketing of the dietary supplement. 
Information that is required in the submission includes the following 
items: (1) The name and address of the manufacturer, packer, or 
distributor of the dietary supplement product; (2) the text of the 
statement that is being made; (3) the name of the dietary ingredient or 
supplement that is the subject of the statement; (4) the name of the 
dietary supplement (including the brand name); and (5) a signature of a 
responsible individual who can certify the accuracy of the information 
presented, and who must certify that the information contained in the 
notice is complete and accurate, and that the notifying firm has 
substantiation that the statement is truthful and not misleading.
    The agency established Sec.  101.93 (21 CFR 101.93) as the 
procedural regulation for this program. Section 101.93 provides details 
of the procedures associated with the submission and identifies the 
information that must be included in order to meet the requirements of 
section 403 of the act.
    Description of Respondents: Respondents to this collection of 
information include manufacturers, packers, or distributors of dietary 
supplements that bear section 403(r)(6) of the act statements on their 
labels or labeling.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
   21 CFR          No. of        Annual Frequency                               Hours per
  Section       Respondents        per Response    Total Annual  Responses       Response         Total Hours
----------------------------------------------------------------------------------------------------------------
101.93                   2,200                  1                    2,200               0.75             1,650
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The agency believes that there will be minimal burden on the 
industry to generate information to meet the requirements of section 
403 of the act in submitting information regarding section 403(r)(6) 
statements on labels or in labeling of dietary supplements. The agency 
is requesting only information that is immediately available to the

[[Page 26407]]

manufacturer, packer, or distributor of the dietary supplement that 
bears such a statement on its label or in its labeling. FDA estimates 
that, each year, approximately 2,200 firms will submit the information 
required by section 403 of the act. We estimate that a firm will 
require 0.75 hours to gather the information needed and prepare a 
communication to FDA, for a total of 1,650 hours (2,200 x 0.75). This 
estimate is based on the average number of notification submissions 
received by the agency in the preceding 2 years.

    Dated: May 26, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12797 Filed 6-1-09; 8:45 am]

BILLING CODE 4160-01-S