Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements
ICR 200706-0910-003
OMB: 0910-0608
Federal Form Document
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0608 can be found here:
Petition to Request an
Exemption from 100 Percent Identity Testing of Dietary Ingredients:
CGMP in Manufacturing, Packaging, Labeling or Holding Operations
for Dietary Supplements
New
collection (Request for a new OMB Control Number)
The information
collection requirements associated with this Interim Final Rule are
approved for 3 years. OMB understands that FDA has extended the
comment period for the IFR to allow for additional public input.
Although granted approval for 3 years, FDA will revise this ICR to
reflect any changes made to the rule as a result of public comment,
and or will revise to include any guidance documents associated
with the petition process.
Inventory as of this Action
Requested
Previously Approved
09/30/2010
36 Months From Approved
972
0
0
3,942
0
0
0
0
0
Section 402(g) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 342 (g)) gives the Food
and Drug Administration (FDA) explicit authority to issue a rule
establishing Current Good Manufacturing Practice 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. Section 402(g)(2) of the act authorizes FDA
to, by regulation, prescribe good manufacturing practices for
dietary supplements. Under section 701(a) of the act (21 U.S.C.
371), FDA may issue regulations necessary for the efficient
enforcement of the act. Given the above legal authority FDA has
decided to redesignate section 111.75(a)(1) of the dietary
supplement final rule as section 111.75(a)(1)(i) and set forth a
procedure for submission of a petition to FDA in a new section
111.75(a)(1)(ii), pursuant to which manufacturers may request an
exemption from the requirements set forth in section
111.75(a)(1)(i) when the dietary ingredient is obtained from one or
more suppliers identified in the petition. The codified provision
set forth in this interim final rule clarifies that FDA is willing
to consider, on a case-by-case basis, a manufacturers 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
our 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, we recognize
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, we decided to add to section
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 section 10.30
and the agency grants such exemption. Such a procedure would be
consistent with our stated goal, as described in the CGMP final
rule, of providing flexibility in the CGMP requirements. We also
include a requirement to ensure that the manufacturer keeps the
FDAs response to a petition submitted under section
111.75(a)(1)(ii) as a record under section 111.95.
FDA has decided to redesignate
section 111.75(a)(1) of the dietary supplement final rule as
section 111.75(a)(1)(i) and set forth a procedure for submission of
a petition to FDA in a new section 111.75(a)(1)(ii), pursuant to
which manufacturers may request an exemption from the requirements
set forth in section 111.75(a)(1)(i) when the dietary ingredient is
obtained from one or more suppliers identified in the petition. The
codified provision set forth in this interim final rule 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 our 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, we recognize 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, we decided to add to section 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 section 10.30 and the agency grants
such exemption. Such a procedure would be consistent with our
stated goal, as described in the CGMP final rule, of providing
flexibility in the CGMP requirements. We also include a requirement
to ensure that the manufacturer keeps the FDA's response to a
petition submitted under section 111.75(a)(1)(ii) as a record under
section 111.95.
$2,665,960
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman
No
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:
(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;
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.
21 USC 371.htm
DS IFR Supporting Statement 5_07_07.doc
Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements