[Federal Register Volume 75, Number 189 (Thursday, September 30, 2010)]
[Notices]
[Pages 60463-60464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24642]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 1, 2010.

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0608. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed

[[Page 60464]]

collection of information to OMB for review and clearance.

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--(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 
FD&C Act) by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)). 
Section 402(g)(2) of the FD&C 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 FD&C 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 FD&C Act (21 U.S.C. 371(a)), FDA may issue 
regulations necessary for the efficient enforcement of the FD&C 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 the 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.
    In the Federal Register of July 20, 2010 (75 FR 42095) FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     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: September 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24642 Filed 9-29-10; 8:45 am]
BILLING CODE 4160-01-S