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, 15159-15161 [2018-07156]
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Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
effectiveness but for which there was
sufficient information to establish
performance standards to provide such
assurance. Accordingly, FDA has
established the above captioned Special
Controls Guidance Document regarding
the labeling of natural rubber latex
condoms.
Condoms without spermicidal
lubricant containing nonoxynol 9 are
classified in class II. They were
originally classified before the
enactment of provisions of the Safe
Medical Devices Act of 1990 (Pub. L.
101–629), which broadened the
definition of class II devices and now
permits FDA to establish special
controls beyond performance standards,
including guidance documents, to help
provide reasonable assurance of the
safety and effectiveness of such devices.
In December 2000, Congress enacted
Public Law 106–554, which directed
FDA to ‘‘reexamine existing condom
labels’’ and ‘‘determine whether the
labels are medically accurate regarding
the overall effectiveness or lack of
effectiveness in preventing sexually
transmitted diseases. . . .’’ In response,
FDA recommended labeling intended to
provide important information for
condom users, including the extent of
protection provided by condoms against
various types of sexually transmitted
diseases.
Respondents to this collection of
information are manufacturers and
repackagers of male condoms made of
natural rubber latex without spermicidal
lubricant. FDA expects approximately
five new manufacturers or repackagers
to enter the market yearly and to
collectively have a third-party
disclosure burden of 60 hours. The
number of respondents cited in table 1
is based on FDA’s database of premarket
submissions and the electronic
registration and listing database. The
average burden per disclosure was
derived from a study performed for FDA
by Eastern Research Group, Inc., an
economic consulting firm, to estimate
the impact of the 1999 over-the-counter
(OTC) human drug labeling
requirements final rule (64 FR 13254,
March 17, 1999). Because the packaging
requirements for condoms are similar to
those of many OTC drugs, we believe
the burden to design the labeling for
OTC drugs is an appropriate proxy for
the estimated burden to design condom
labeling.
The special controls guidance
document also refers to previously
approved collections of information
found in FDA regulations. The
collections of information in 21 CFR
part 801 have been approved under
OMB control number 0910–0485; the
collections of information in 21 CFR
part 807, subpart E have been approved
under OMB control number 0910–0120;
and the collections of information in 21
CFR part 820 have been approved under
OMB control number 0910–0073.
The collection of information under
21 CFR 801.437 does not constitute a
‘‘collection of information’’ under the
PRA. Rather, it is a ‘‘public disclosure
of information originally supplied by
the Federal Government to the recipient
for the purpose of disclosure to the
public’’ (5 CFR 1320.3(c)(2)).
In the Federal Register of November
9, 2017 (82 FR 52056) FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received in response to the notice.
We therefore retain the currently
approved burden estimate for the
information collection, which is as
follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Class II Special Controls Guidance Document: Labeling
for Natural Rubber Latex Condoms Classified Under 21
CFR 884.5300 ..................................................................
1 There
Number of
disclosures
per
respondent
Number of
respondents
Activity
5
1
5
12
Total hours
60
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07153 Filed 4–6–18; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1011]
BILLING CODE 4164–01–P
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
sradovich on DSK3GMQ082PROD with NOTICES
Average
burden per
disclosure
Total annual
disclosures
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
SUMMARY:
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18:06 Apr 06, 2018
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Fmt 4703
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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
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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.
sradovich on DSK3GMQ082PROD with NOTICES
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
VerDate Sep<11>2014
18:06 Apr 06, 2018
Jkt 244001
‘‘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/201523389.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, PRAStaff@
fda.hhs.gov.
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
PO 00000
Frm 00036
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Sfmt 4703
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)
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Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
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
§ 111.75(a)(1)(ii), manufacturers may
request an exemption from the
requirements set forth in
§ 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 § 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 § 111.75(a)(1)(ii) as a record
under § 111.95 (21 CFR 111.95). The
collection of information in § 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
111.75(a)(1)(ii); Determining whether specifications are
met ..................................................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section/activity
1
1
Average
burden per
response
1
Total hours
8
8
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
SUMMARY:
[FR Doc. 2018–07156 Filed 4–6–18; 8:45 am]
BILLING CODE 4164–01–P
sradovich on DSK3GMQ082PROD with NOTICES
Total
annual
responses
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Food and Drug Administration
[Docket No. FDA–2018–D–1201]
Pregnant Women: Scientific and
Ethical Considerations for Inclusion in
Clinical Trials; Draft Guidance;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Pregnant
Women: Scientific and Ethical
Considerations for Inclusion in Clinical
Trials.’’ This draft guidance discusses
the ethical and scientific issues when
considering the inclusion of pregnant
women in clinical trials of drugs and
biological products. This draft guidance
is intended to advance scientific
research in pregnant women, and
discusses issues that should be
considered within the framework of
human subject protection regulations.
DATES: Submit either electronic or
written comments on the draft guidance
PO 00000
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by June 8, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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
E:\FR\FM\09APN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section/activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
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
