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, 32880-32881 [2018-15088]
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32880
Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices
Dated: July 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
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—21 CFR 111.75(a)(1)(ii)
[FR Doc. 2018–15092 Filed 7–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
OMB Control Number 0910–0608—
Extension
[Docket No. FDA–2018–N–1011]
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.
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 August 15,
2018.
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 oira_
submission@omb.eop.gov. 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.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
sradovich on DSK3GMQ082PROD with NOTICES
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:31 Jul 13, 2018
Jkt 244001
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)
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.
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
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 § 10.30 (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.
In the Federal Register of April 9,
2018 (83 FR 15159), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was received
suggesting that ‘‘microbial cultures and
probiotics should not be required to go
through such a process to ensure
exemption from the Agency’s 100
percent identity testing requirement,’’
but did not suggest a revision to the
estimated burden. We appreciate this
comment, however, we believe that the
current requirements impose minimal
information collection while
simultaneously ensuring the safety of
dietary supplements.
We estimate the burden of the
information collection as follows:
E:\FR\FM\16JYN1.SGM
16JYN1
32881
Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
111.75(a)(1)(ii); Determining whether specifications are
met ....................................................................................
1
1
1
8
8
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.
INFORMATION section for registration date
and information.
ADDRESSES: The conference will be held
at FDA’s White Oak Campus, 10903
New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503–A), Silver Spring, MD 20993.
Entrance for the conference participants
(non-FDA employees) is through
Building 1 where routine security check
procedures will be performed. For
parking and security information, please
refer to https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
differences may influence susceptibility
to substance abuse, which could have
implications for optimal prevention and
treatment. Gender influencers also
impact public health from a familial and
environmental perspective. Researchers,
educators, and clinicians must be able
to recognize and consider both sex and
gender differences to identify and treat
women most at risk.
II. Topics for Discussion at the
Conference
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Gwendolyn Jones, Food and Drug
Administration, Bldg. 32, Rm. 2333,
10903 New Hampshire Ave., Silver
Spring, MD 20993, OWH_OandNConf@
fda.hhs.gov, 301–796–9940.
SUPPLEMENTARY INFORMATION:
The conference will include
presentations and panel discussions by
experts in the field of opioid and
tobacco research, professional
education, and clinical care on the
biological (sex) and sociological
(gender) influences on misuse, abuse,
and cessation of opioids and tobacco.
Each panel discussion will have a Q&A
session to respond to questions from inperson attendees.
Food and Drug Administration
I. Background
III. Participating in the Conference
FDA is responsible for protecting the
public health by assuring the safety and
efficacy of FDA-regulated products. This
conference will provide the Agency
with further insight into the devastating
public health crises caused by pervasive
opioid and tobacco use. Drug overdose
deaths and opioid-involved deaths
continue to increase in the United
States. Many of the drug overdose
deaths (more than 6 out of 10) involve
an opioid. Since 1999, the number of
overdose deaths involving opioids
(including prescription opioids and
heroin) quadrupled. Drug overdose
deaths and opioid-involved deaths
continue to increase in the United
States. Of the 63,632 drug overdose
deaths in 2016, 66.4 percent (42,249)
involved opioids, with increases across
age groups, racial/ethnic groups,
urbanization levels, and multiple states.
Combustible cigarettes have been
identified as the dominant cause of
tobacco-related disease and are
responsible for more than 20 million
premature deaths since the first Surgeon
General’s report in 1964. Together,
opioid and tobacco use are the leading
causes of preventable disease and death
in the United States, and women are
increasingly affected. Sex and gender
Registration: To register for the
Scientific Conference: Opioid and
Nicotine Use, Dependence, and
Recovery—Influences of Sex and
Gender, please visit the following
website: https://www.eventbrite.com/e/
scientific-conference-opioid-andnicotine-use-dependence-and-recoveryinfluences-of-sex-and-gender-tickets47087275308.
Registration is free and in-person
seating is limited. The conference will
also be available for viewing via
webcast. Persons interested in attending
or viewing this conference must register
online by September 24, 2018, 5:00 p.m.
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted. If you need special
accommodations due to a disability,
please email Gwendolyn Jones at OWH_
OandNConf@fda.hhs.gov (See FOR
FURTHER INFORMATION CONTACT) no later
than September 24, 2018.
Streaming Webcast of the public
meeting: This public meeting will also
be webcast and can only be viewed if
registered. To register, please go to
Dated: July 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2018–15088 Filed 7–13–18; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2018–N–0001]
Scientific Conference: Opioid and
Nicotine Use, Dependence, and
Recovery—Influences of Sex and
Gender; Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public meeting.
The Food and Drug
Administration’s (FDA or Agency)
Office of Women’s Health, Center for
Drug Evaluation and Research, and
Center for Tobacco Products are
announcing the following conference
entitled ‘‘Scientific Conference: Opioid
and Nicotine Use, Dependence, and
Recovery—Influences of Sex and
Gender.’’ The purpose of the conference
is to discuss the biological (sex) and
sociological (gender) influences on
misuse, abuse, and cessation of opioids
and tobacco. Researchers, educators,
and clinicians may benefit from
attending this multidisciplinary review
and update on opioid and tobacco.
DATES: The two-day conference will be
held on September 27, 2018 (8:30 a.m.–
4:00 p.m.) and September 28, 2018 (8:30
a.m.–4:00 p.m.). See the SUPPLEMENTARY
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:31 Jul 13, 2018
Jkt 244001
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
E:\FR\FM\16JYN1.SGM
16JYN1
]]>Agencies
[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32880-32881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15088]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1011]
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.
-----------------------------------------------------------------------
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 August
15, 2018.
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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed 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--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) 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 Sec. 10.30 (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.
In the Federal Register of April 9, 2018 (83 FR 15159), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received suggesting that
``microbial cultures and probiotics should not be required to go
through such a process to ensure exemption from the Agency's 100
percent identity testing requirement,'' but did not suggest a revision
to the estimated burden. We appreciate this comment, however, we
believe that the current requirements impose minimal information
collection while simultaneously ensuring the safety of dietary
supplements.
We estimate the burden of the information collection as follows:
[[Page 32881]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.75(a)(1)(ii); Determining whether specifications are met....... 1 1 1 8 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: July 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15088 Filed 7-13-18; 8:45 am]
BILLING CODE 4164-01-P
