[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