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, 12491-12493 [2015-05357]
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Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
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States, and includes input from both
regulatory and industry representatives.
The VICH Steering Committee is
composed of member representatives
from the European Commission,
European Medicines Evaluation Agency,
European Federation of Animal Health,
Committee on Veterinary Medicinal
Products, FDA, U.S. Department of
Agriculture, the Animal Health
Institute, Japanese Veterinary
Pharmaceutical Association, Japanese
Association of Veterinary Biologics, and
Japanese Ministry of Agriculture,
Forestry, and Fisheries.
Six observers are eligible to
participate in the VICH Steering
Committee: One representative from the
government of Australia/New Zealand,
one representative from the industry in
Australia/New Zealand, one
representative from the government of
Canada, one representative from the
industry of Canada, one representative
from the government of South Africa,
and one representative from the
industry of South Africa. The VICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation for Animal Health (IFAH).
An IFAH representative also
participates in the VICH Steering
Committee meetings.
II. Revised Guidance on Studies To
Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in FoodProducing Animals: Validation of
Analytical Methods Used in Residue
Depletion Studies
In June 2014, the VICH Steering
Committee agreed that a revised
guidance document entitled ‘‘Studies to
Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in FoodProducing Animals: Validation of
Analytical Methods Used in Residue
Depletion Studies’’ (VICH GL49(R))
should be made available to the public.
This revised guidance is a revision of a
final guidance on the same topic for
which a notice of availability was
published in the Federal Register of
September 15, 2011 (76 FR 57056). The
revised guidance makes minor changes
such as correcting a typographical error
in table 2 (Annex 3). Also, the
explanatory text for table 2 (Annex 3)
was revised to correct a description of
the statistical model and to provide an
explanation of the procedure used to
generate the data in the table. This
revised guidance is a product of the
Metabolism and Residue Kinetics Expert
Working Group of the VICH.
During the veterinary drug
development process, residue depletion
studies are conducted to determine the
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concentration of the residue or residues
present in the edible products (tissues,
milk, eggs, or honey) of animals treated
with veterinary drugs. This information
is used in regulatory submissions
around the world. Submission of
regulatory methods (i.e., postapproval
control methods) and the validation
requirements of the regulatory methods
are usually well defined by various
regulatory agencies worldwide and
might even be defined by national or
regional law. However, the residue
depletion studies are generally
conducted before the regulatory
methods have been completed.
Oftentimes the in-house validated
residue methods provide the framework
for the methods submitted for regulatory
monitoring. Harmonization of the
validation requirements for
methodology used during residue
depletion studies and submitted to the
regulatory agencies in support of the
maximum residue limits and
withdrawal periods should be
achievable. It is the intent of this
document to describe a validation
procedure that is acceptable to the
regulatory bodies of the VICH regions
for use in the residue depletion studies.
This validated method could continue
on to become the ‘‘regulatory method’’
but that phase of the process will not be
addressed in any detail in this guidance.
For purposes of this guidance, the term
‘‘acceptable’’ refers to the scientific
evaluation of the analytical method in
terms of the described validation
criteria, not to acceptance of the
analytical method as satisfying the
applicable national/regional laws and
regulations of any of the relevant
regulatory bodies.
III. Significance of Guidance
As a result of Level 2 revisions, this
VICH revised guidance is being issued
in final, consistent with FDA’s good
guidance practice (GGP) regulations at
21 CFR 10.115(g)(4). This guidance,
developed under the VICH process, has
been revised to conform to FDA’s GGP
regulation (21 CFR 10.115). For
example, the document has been
designated ‘‘guidance’’ rather than
‘‘guideline.’’ In addition, guidance
documents must not include mandatory
language such as ‘‘shall,’’ ‘‘must,’’
‘‘require,’’ or ‘‘requirement,’’ unless
FDA is using these words to describe a
statutory or regulatory requirement.
This VICH guidance represents the
Agency’s current thinking on this topic.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
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12491
requirements of applicable statutes and
regulations.
IV. Paperwork Reduction Act of 1995
This revised guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 514 have
been approved under OMB control
number 0910–0032.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to www.regulations.gov or
written comments to the Division of
Dockets Management (see ADDRESSES).
It is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
VI. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: March 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05346 Filed 3–6–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1152]
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.
The Food and Drug
Administration (FDA) is announcing an
SUMMARY:
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12492
Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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 invites comments on
the information collection provisions of
our existing 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 May 8, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, 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
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
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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)
The Dietary Supplement Health and
Education Act (DSHEA) (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 (the Secretary) 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
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
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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 § 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.
Description of Respondents: The
respondents to this collection of
information are firms in the dietary
supplement industry, including dietary
supplement manufacturers, packagers
and re-packagers, holders, labelers and
re-labelers, distributors, warehouses,
exporters, importers, large businesses,
and small businesses.
We estimate the burden of this
collection of information as follows:
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Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section; CGMP requirements for dietary supplements
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
111.75(a)(1)(ii) .....................................................................................
1
1
1
8
8
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
In the last 3 years, we have not
received any new petitions to request an
exemption from 100 percent identity
testing of dietary ingredients; therefore,
the Agency estimates that one or fewer
petitions will be submitted annually.
Based on our experience with petition
processes, we estimate it will take a
requestor about 8 hours to prepare the
factual and legal information necessary
to support a petition for exemption and
to prepare the petition. Although we
have not received any new petitions to
request an exemption from 100 percent
identity testing of dietary ingredients in
the last 3 years, we believe that OMB
approval of these information collection
provisions should be extended to
provide for the potential future need of
a firm in the dietary supplement
industry to petition for an exemption
from 100 percent identity testing of
dietary ingredients.
Dated: March 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05357 Filed 3–6–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Meeting of the National Advisory
Council for Healthcare Research and
Quality
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of public meeting.
AGENCY:
In accordance with section
10(a) of the Federal Advisory Committee
Act, 5 U.S.C. App. 2, this notice
announces a meeting of the National
Advisory Council for Healthcare
Research and Quality.
DATES: The meeting will be held on
Friday, March 27, 2015, from 8:30 a.m.
to 3:00 p.m.
ADDRESSES: The meeting will be held at
the Eisenberg Conference Center,
Agency for Healthcare Research and
Quality, 540 Gaither Road, Rockville,
Maryland 20850.
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SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Jaime Zimmerman, Designated
Management Official, at the Agency for
Healthcare Research and Quality, 540
Gaither Road, Rockville, Maryland
20850, (301) 427–1456. For press-related
information, please contact Alison Hunt
at (301) 427–1244.
If sign language interpretation or other
reasonable accommodation for a
disability is needed, please contact the
Food and Drug Administration (FDA)
Office of Equal Employment
Opportunity and Diversity Management
on (301) 827–4840, no later than Friday,
March 13, 2015. The agenda, roster, and
minutes are available from Ms. Bonnie
Campbell, Committee Management
Officer, Agency for Healthcare Research
and Quality, 540 Gaither Road,
Rockville, Maryland 20850. Ms.
Campbell’s phone number is (301) 427–
1554.
SUPPLEMENTARY INFORMATION:
I. Purpose
The National Advisory Council for
Healthcare Research and Quality is
authorized by Section 941 of the Public
Health Service Act, 42 U.S.C. 299c. In
accordance with its statutory mandate,
the Council is to advise the Secretary of
the Department of Health and Human
Services and the Director, Agency for
Healthcare Research and Quality
(AHRQ), on matters related to AHRQ’s
conduct of its mission including
providing guidance on (A) priorities for
health care research, (B) the field of
health care research including training
needs and information dissemination on
health care quality and (C) the role of
the Agency in light of private sector
activity and opportunities for public
private partnerships.
The Council is composed of members
of the public, appointed by the
Secretary, and Federal ex-officio
members specified in the authorizing
legislation.
II. Agenda
On Friday, March 27, 2015, there will
be a subcommittee meeting for the
National Healthcare Quality and
Disparities Report scheduled to begin at
7:30 a.m. The subcommittee meeting is
open the public. The Council meeting
will convene at 8:30 a.m., with the call
PO 00000
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to order by the Council Chair and
approval of previous Council summary
notes. The meeting is open to the public
and will be available via webcast at
www.webconferences.com/ahrq . The
meeting will begin with the AHRQ
Director presenting an update on
current research, programs, and
initiatives. Following the Director’s
Update, the agenda will include an
update on AHRQ insurance-related
research and a discussion of Patient
Centered Outcomes Research (PCOR)
Dissemination and Implementation. The
final agenda will be available on the
AHRQ Web site at www.AHRQ.gov no
later than Friday, March 20, 2015.
Dated: March 4, 2015.
Carla Ladner,
Correspondence Analyst.
[FR Doc. 2015–05399 Filed 3–6–15; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Hepatitis B Research
Network.
Date: March 25, 2015.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12491-12493]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05357]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1152]
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) is announcing an
[[Page 12492]]
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 invites comments on the information collection
provisions of our existing 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 May 8, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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 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)
The Dietary Supplement Health and Education Act (DSHEA) (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 (the Secretary) 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 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.
Description of Respondents: The respondents to this collection of
information are firms in the dietary supplement industry, including
dietary supplement manufacturers, packagers and re-packagers, holders,
labelers and re-labelers, distributors, warehouses, exporters,
importers, large businesses, and small businesses.
We estimate the burden of this collection of information as
follows:
[[Page 12493]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section; CGMP requirements for Number of responses per Total annual burden per Total hours
dietary supplements respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
111.75(a)(1)(ii)....................... 1 1 1 8 8
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
In the last 3 years, we have not received any new petitions to
request an exemption from 100 percent identity testing of dietary
ingredients; therefore, the Agency estimates that one or fewer
petitions will be submitted annually. Based on our experience with
petition processes, we estimate it will take a requestor about 8 hours
to prepare the factual and legal information necessary to support a
petition for exemption and to prepare the petition. Although we have
not received any new petitions to request an exemption from 100 percent
identity testing of dietary ingredients in the last 3 years, we believe
that OMB approval of these information collection provisions should be
extended to provide for the potential future need of a firm in the
dietary supplement industry to petition for an exemption from 100
percent identity testing of dietary ingredients.
Dated: March 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05357 Filed 3-6-15; 8:45 am]
BILLING CODE 4164-01-P
