83 FR 32880 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 136 (July 16, 2018)

Page Range		32880-32881
FR Document		2018-15088

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.

Federal Register, Volume 83 Issue 136 (Monday, July 16, 2018)

[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32880-32881]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-15088]

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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 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.

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,
PRAStaff@fda.hhs.gov.

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

32880 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices

Dated: July 9, 2018. collection of information to OMB for Section 111.75(a)(1) reflects our
Leslie Kux, review and clearance. determination that manufacturers that
Associate Commissioner for Policy. test or examine 100 percent of the
Petition To Request an Exemption From
[FR Doc. 2018–15092 Filed 7–13–18; 8:45 am] incoming dietary ingredients for
100 Percent Identity Testing of Dietary
identity can be assured of the identity
BILLING CODE 4164–01–P Ingredients: Current Good
of the ingredient. However, we
Manufacturing Practice in
recognize that it may be possible for a
Manufacturing, Packaging, Labeling, or
DEPARTMENT OF HEALTH AND manufacturer to demonstrate, through
Holding Operations for Dietary
HUMAN SERVICES various methods and processes in use
Supplements—21 CFR 111.75(a)(1)(ii)
over time for its particular operation,
Food and Drug Administration OMB Control Number 0910–0608— that a system of less than 100 percent
Extension identity testing would result in no
[Docket No. FDA–2018–N–1011]
material diminution of assurance of the
This information collection supports identity of the dietary ingredient as
Agency Information Collection Agency regulations. The Dietary
Activities; Submission for Office of compared to the assurance provided by
Supplement Health and Education Act 100 percent identity testing. To provide
Management and Budget Review; (Pub. L. 103–417) added section 402(g)
Comment Request; Petition To an opportunity for a manufacturer to
of the Federal Food, Drug, and Cosmetic make such a showing and reduce the
Request an Exemption From 100 Act (FD&C Act) (21 U.S.C. 342(g)),
Percent Identity Testing of Dietary frequency of identity testing of
which provides, in part, that the components that are dietary ingredients
Ingredients: Current Good Secretary of Health and Human Services
Manufacturing Practice in from 100 percent to some lower
may, by regulation, prescribe good frequency, we added to § 111.75(a)(1),
Manufacturing, Packaging, Labeling, or manufacturing practices for dietary
Holding Operations for Dietary an exemption from the requirement of
supplements. Section 402(g)(1) of the 100 percent identity testing when a
Supplements FD&C Act states that a dietary manufacturer petitions the Agency for
AGENCY: Food and Drug Administration, supplement is adulterated if it has been such an exemption to 100 percent
HHS. prepared, packed, or held under the identity testing under § 10.30 (21 CFR
ACTION: Notice. types of conditions that do not meet 10.30) and the Agency grants such
current good manufacturing practice exemption. Such a procedure would be
SUMMARY: The Food and Drug regulations. Section 701(a) of the FD&C consistent with our stated goal, as
Administration (FDA) is announcing Act (21 U.S.C. 371(a)) gives us the described in the CGMP final rule, of
that a proposed collection of authority to issue regulations for the providing flexibility in the CGMP
information has been submitted to the efficient enforcement of the FD&C Act. requirements. Section 111.75(a)(1)(ii)
Office of Management and Budget Part 111 (21 CFR part 111) establishes sets forth the information a
(OMB) for review and clearance under the minimum Current Good manufacturer is required to submit in
the Paperwork Reduction Act of 1995. Manufacturing Practice (CGMP) such a petition. The regulation also
DATES: Fax written comments on the necessary for activities related to contains a requirement to ensure that
collection of information by August 15, manufacturing, packaging, labeling, or the manufacturer keeps our response to
2018. holding dietary supplements to ensure a petition submitted under
ADDRESSES: To ensure that comments on the quality of the dietary supplement. § 111.75(a)(1)(ii) as a record under
the information collection are received, Section 111.75(a)(1) of our regulations § 111.95 (21 CFR 111.95). The collection
OMB recommends that written (21 CFR 111.75(a)(1)) establishes a of information in § 111.95 has been
comments be faxed to the Office of procedure for a petition to request an approved under OMB control number
Information and Regulatory Affairs, exemption from 100 percent identity 0910–0606.
OMB, Attn: FDA Desk Officer, Fax: 202– testing of dietary ingredients. Under In the Federal Register of April 9,
395–7285, or emailed to oira_ § 111.75(a)(1)(ii), manufacturers may 2018 (83 FR 15159), FDA published a
submission@omb.eop.gov. All request an exemption from the 60-day notice requesting public
comments should be identified with the requirements set forth in comment on the proposed collection of
OMB control number 0910–0608. Also § 111.75(a)(1)(i) when the dietary information. One comment was received
include the FDA docket number found ingredient is obtained from one or more suggesting that ‘‘microbial cultures and
in brackets in the heading of this suppliers identified in the petition. The probiotics should not be required to go
document. regulation clarifies that we are willing to through such a process to ensure
consider, on a case-by-case basis, a exemption from the Agency’s 100
FOR FURTHER INFORMATION CONTACT: percent identity testing requirement,’’
manufacturer’s conclusion, supported
Domini Bean, Office of Operations, by appropriate data and information in but did not suggest a revision to the
Food and Drug Administration, Three the petition submission, that it has estimated burden. We appreciate this
White Flint North, 10A–12M, 11601 developed a system that it would comment, however, we believe that the
Landsdown St., North Bethesda, MD implement as a sound, consistent means current requirements impose minimal
20852, 301–796–5733, PRAStaff@ of establishing, with no material information collection while
fda.hhs.gov. diminution of assurance compared to simultaneously ensuring the safety of
SUPPLEMENTARY INFORMATION: In the assurance provided by 100 percent dietary supplements.
sradovich on DSK3GMQ082PROD with NOTICES

compliance with 44 U.S.C. 3507, FDA identity testing, the identity of the We estimate the burden of the
has submitted the following proposed dietary ingredient before use. information collection as follows:

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Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 32881

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section; activity responses per burden per Total hours
respondents responses
respondent 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 section for registration date differences may influence susceptibility
information collection, we have and information. to substance abuse, which could have
received no petitions. We therefore ADDRESSES: The conference will be held implications for optimal prevention and
retain the currently approved estimated at FDA’s White Oak Campus, 10903 treatment. Gender influencers also
burden which assumes no more than New Hampshire Ave., Bldg. 31 impact public health from a familial and
one petition will be submitted annually. Conference Center, the Great Room (Rm. environmental perspective. Researchers,
We further assume it would take 1503–A), Silver Spring, MD 20993. educators, and clinicians must be able
respondents 8 hours to prepare the Entrance for the conference participants to recognize and consider both sex and
factual and legal information necessary (non-FDA employees) is through gender differences to identify and treat
to support a petition for exemption and Building 1 where routine security check women most at risk.
to prepare the petition, for a total of 8 procedures will be performed. For II. Topics for Discussion at the
burden hours annually. These figures parking and security information, please Conference
are based on our experience with the refer to https://www.fda.gov/AboutFDA/
information collection. WorkingatFDA/BuildingsandFacilities/ The conference will include
Dated: July 10, 2018. WhiteOakCampusInformation/ presentations and panel discussions by
ucm241740.htm. experts in the field of opioid and
Leslie Kux,
tobacco research, professional
Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: education, and clinical care on the
[FR Doc. 2018–15088 Filed 7–13–18; 8:45 am] Gwendolyn Jones, Food and Drug biological (sex) and sociological
BILLING CODE 4164–01–P Administration, Bldg. 32, Rm. 2333, (gender) influences on misuse, abuse,
10903 New Hampshire Ave., Silver and cessation of opioids and tobacco.
Spring, MD 20993, OWH_OandNConf@ Each panel discussion will have a Q&A
DEPARTMENT OF HEALTH AND fda.hhs.gov, 301–796–9940. session to respond to questions from in-
HUMAN SERVICES SUPPLEMENTARY INFORMATION: person attendees.
Food and Drug Administration I. Background III. Participating in the Conference
FDA is responsible for protecting the Registration: To register for the
[Docket No. FDA–2018–N–0001]
public health by assuring the safety and Scientific Conference: Opioid and
Scientific Conference: Opioid and efficacy of FDA-regulated products. This Nicotine Use, Dependence, and
Nicotine Use, Dependence, and conference will provide the Agency Recovery—Influences of Sex and
Recovery—Influences of Sex and with further insight into the devastating Gender, please visit the following
Gender; Public Meeting public health crises caused by pervasive website: https://www.eventbrite.com/e/
opioid and tobacco use. Drug overdose scientific-conference-opioid-and-
AGENCY: Food and Drug Administration, deaths and opioid-involved deaths nicotine-use-dependence-and-recovery-
HHS. continue to increase in the United influences-of-sex-and-gender-tickets-
ACTION: Notice of public meeting. States. Many of the drug overdose 47087275308.
deaths (more than 6 out of 10) involve Registration is free and in-person
SUMMARY: The Food and Drug an opioid. Since 1999, the number of seating is limited. The conference will
Administration’s (FDA or Agency) overdose deaths involving opioids also be available for viewing via
Office of Women’s Health, Center for (including prescription opioids and webcast. Persons interested in attending
Drug Evaluation and Research, and heroin) quadrupled. Drug overdose or viewing this conference must register
Center for Tobacco Products are deaths and opioid-involved deaths online by September 24, 2018, 5:00 p.m.
announcing the following conference continue to increase in the United Eastern Time. Early registration is
entitled ‘‘Scientific Conference: Opioid States. Of the 63,632 drug overdose recommended because seating is
and Nicotine Use, Dependence, and deaths in 2016, 66.4 percent (42,249) limited; therefore, FDA may limit the
Recovery—Influences of Sex and involved opioids, with increases across number of participants from each
Gender.’’ The purpose of the conference age groups, racial/ethnic groups, organization. Registrants will receive
is to discuss the biological (sex) and urbanization levels, and multiple states. confirmation when they have been
sociological (gender) influences on Combustible cigarettes have been accepted. If you need special
misuse, abuse, and cessation of opioids identified as the dominant cause of accommodations due to a disability,
and tobacco. Researchers, educators, tobacco-related disease and are please email Gwendolyn Jones at OWH_
sradovich on DSK3GMQ082PROD with NOTICES

and clinicians may benefit from responsible for more than 20 million OandNConf@fda.hhs.gov (See FOR
attending this multidisciplinary review premature deaths since the first Surgeon FURTHER INFORMATION CONTACT) no later
and update on opioid and tobacco. General’s report in 1964. Together, than September 24, 2018.
DATES: The two-day conference will be opioid and tobacco use are the leading Streaming Webcast of the public
held on September 27, 2018 (8:30 a.m.– causes of preventable disease and death meeting: This public meeting will also
4:00 p.m.) and September 28, 2018 (8:30 in the United States, and women are be webcast and can only be viewed if
a.m.–4:00 p.m.). See the SUPPLEMENTARY increasingly affected. Sex and gender registered. To register, please go to

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Document Created: 2018-07-14 00:53:43
Document Modified: 2018-07-14 00:53:43

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by August 15, 2018.
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]
FR Citation		83 FR 32880

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 136 (July 16, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration