[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15159-15161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07156]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1011]
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 June 8, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 8, 2018. The https://www.regulations.gov
[[Page 15160]]
electronic filing system will accept comments until midnight Eastern
Time at the end of June 8, 2018. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-1011 for ``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.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
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
This information collection supports Agency regulations. The
Dietary Supplement Health and Education Act (Pub. L. 103-417) added
section 402(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 342(g)), which provides, in part, that the Secretary of
Health and Human Services 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 the types of conditions that do
not meet current good manufacturing practice regulations. Section
701(a) of the FD&C Act (21 U.S.C. 371(a)) gives us the authority to
issue regulations for the efficient enforcement of the FD&C Act.
Part 111 (21 CFR part 111) establishes the minimum current good
manufacturing practice (CGMP)
[[Page 15161]]
necessary for activities related to manufacturing, packaging, labeling,
or holding dietary supplements to ensure the quality of the dietary
supplement. Section 111.75(a)(1) of our regulations (21 CFR
111.75(a)(1)) establishes a procedure for a petition to request an
exemption from 100 percent identity testing of dietary ingredients.
Under Sec. 111.75(a)(1)(ii), 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 we are 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) 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 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 21 CFR 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. 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 our
response to a petition submitted under Sec. 111.75(a)(1)(ii) as a
record under Sec. 111.95 (21 CFR 111.95). The collection of
information in Sec. 111.95 has been approved under OMB control number
0910-0606.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
21 CFR section/activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
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111.75(a)(1)(ii); Determining 1 1 1 8 8
whether specifications are met
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Since OMB's last approval of the information collection, we have
received no petitions. We therefore retain the currently approved
estimated burden, which assumes no more than one petition will be
submitted annually. We further assume it would take respondents 8 hours
to prepare the factual and legal information necessary to support a
petition for exemption and to prepare the petition, for a total of 8
burden hours annually. These figures are based on our experience with
the information collection.
Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07156 Filed 4-6-18; 8:45 am]
BILLING CODE 4164-01-P