
[Federal Register: July 20, 2010 (Volume 75, Number 138)]
[Notices]               
[Page 42095-42097]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jy10-57]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0374]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Petition to Request an Exemption From 100 Percent 
Identity Testing of Dietary Ingredients: Current Good Manufacturing 
Practice in Manufacturing, Packaging, Labeling, or Holding Operations 
for Dietary Supplements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 reporting requirements 
contained in existing FDA regulations governing petitions to request an 
exemption from 100 percent identity testing of dietary ingredients.

DATES:  Submit either electronic or written comments on the collection 
of information by September 20, 2010.

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

[[Page 42096]]

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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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.

Petition to Request an Exemption From 100 Percent Identity Testing of 
Dietary Ingredients: Current Good Manufacturing Practice in 
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary 
Supplements--21 CFR 111.75(a)(1)(ii) (OMB Control Number 0910-0608)--
Extension

    On October 25, 1994, the Dietary Supplement Health and Education 
Act (DSHEA) (Public Law 103-417) was signed into law. DSHEA, among 
other things, amended the Federal Food, Drug, and Cosmetic Act (the 
act) by adding section 402(g) of the act (21 U.S.C. 342(g)). Section 
402(g)(2) of the act provides, in part, that the Secretary of Health 
and Human Services (the Secretary) may, by regulation, prescribe good 
manufacturing practices for dietary supplements. Section 402(g)(1) of 
the act states that a dietary supplement is adulterated if ``it has 
been prepared, packed, or held under conditions that do not meet 
current good manufacturing practice regulations.'' Under section 701(a) 
of the act (21 U.S.C. 371(a)), FDA may issue regulations necessary for 
the efficient enforcement of the act.
    FDA published a final rule on June 25, 2007 (72 FR 34752) (the 
final rule), that established, in part 111 (21 CFR part 111), the 
minimum Current Good Manufacturing Practice (CGMP) necessary for 
activities related to manufacturing, packaging, labeling, or holding 
dietary supplements to ensure the quality of the dietary supplement. On 
June 25, 2007 (72 FR 34959), FDA also published an Interim Final Rule 
(the IFR) establishing a procedure for a petition to request an 
exemption from 100 percent identity testing of dietary ingredients. The 
IFR redesignated Sec.  111.75(a)(1) of the CGMP final rule as Sec.  
111.75(a)(1)(i) and set forth a procedure for submission of a petition 
to FDA in a new Sec.  111.75(a)(1)(ii), under which manufacturers may 
request an exemption from the requirements set forth in Sec.  
111.75(a)(1)(i) when the dietary ingredient is obtained from one or 
more suppliers identified in the petition. The regulation clarifies 
that FDA is willing to consider, on a case-by-case basis, a 
manufacturer's conclusion, supported by appropriate data and 
information in the petition submission, that it has developed a system 
that it would implement as a sound, consistent means of establishing, 
with no material diminution of assurance compared to the assurance 
provided by 100 percent identity testing, the identity of the dietary 
ingredient before use.
    Section 111.75(a)(1) of the CGMP final rule reflects FDA's 
determination that manufacturers that test or examine 100 percent of 
the incoming dietary ingredients for identity can be assured of the 
identity of the ingredient. However, FDA recognizes that it may be 
possible for a manufacturer to demonstrate, through various methods and 
processes in use over time for its particular operation, that a system 
of less than 100 percent identity testing would result in no material 
diminution of assurance of the identity of the dietary ingredient as 
compared to the assurance provided by 100 percent identity testing. To 
provide an opportunity for a manufacturer to make such a showing and 
reduce the frequency of identity testing of components that are dietary 
ingredients from 100 percent to some lower frequency, FDA added to 
Sec.  111.75(a)(1), an exemption from the requirement of 100 percent 
identity testing when a manufacturer petitions the agency for such an 
exemption to 100 percent identity testing under Sec.  10.30 and the 
agency grants such exemption. Such a procedure would be consistent with 
FDA's stated goal, as described in the CGMP final rule, of providing 
flexibility in the CGMP requirements. Section 111.75(a)(1)(ii) sets 
forth the information a manufacturer is required to submit in such a 
petition. The regulation also contains a requirement to ensure that the 
manufacturer keeps FDA's response to a petition submitted under Sec.  
111.75(a)(1)(ii) as a record under Sec.  111.95. The collection of 
information in Sec.  111.95 has been approved under OMB control number 
0910-0606.
    Description of Respondents: The respondents to this collection of 
information are firms in the dietary supplement industry, including 
dietary supplement manufacturers, packagers and re-packagers, holders, 
labelers and re-labelers, distributors, warehouses, exporters, 
importers, large businesses, and small businesses.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 42097]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                         Number of        Annual Frequency       Total Annual          Hours per
                  21 CFR Section                        Respondents         per Response           Responses           Response           Total Hours
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111.75(a)(1)(ii)                                                     1                     1                   1                   8                   8
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the last 3 years, FDA has not received any new petitions to 
request an exemption from 100 percent identity testing of dietary 
ingredients; therefore, the agency estimates that one or fewer 
petitions will be submitted annually. Although FDA has not received any 
new petitions to request an exemption from 100 percent identity testing 
of dietary ingredients in the last 3 years, it believes that these 
information collection provisions should be extended to provide for the 
potential future need of a firm in the dietary supplement industry to 
petition for an exemption from 100 percent identity testing of dietary 
ingredients. Based on our experience with petition processes, we 
estimate that the assembly of information in support of the petition 
required by Sec.  111.75(a)(1)(ii) will take 8 hours.

    Dated: July 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17608 Filed 7-19-10; 8:45 am]
BILLING CODE 4160-01-S

