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, 68453-68454 [2013-27222]
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Federal Register / Vol. 78, No. 220 / Thursday, November 14, 2013 / Notices
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013–27221 Filed 11–13–13; 8:45 am]
BILLING CODE 4184–01–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 or we) is
announcing an 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 January 13, 2014.
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, 1350 Piccard
TKELleY on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
19:20 Nov 13, 2013
Jkt 232001
Dr., PI50–400B, Rockville, MD 20850,
301–796–3793, 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 (Pub. L. 103–417) added
section 402(g) of the Federal Food, Drug,
and Cosmetic Act (the 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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
68453
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 of our regulations (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.
According to § 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-bycase 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
E:\FR\FM\14NON1.SGM
14NON1
68454
Federal Register / Vol. 78, No. 220 / Thursday, November 14, 2013 / Notices
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. The collection of
information in § 111.95 has been
approved under OMB Control No. 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:
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
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: November 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–27222 Filed 11–13–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
TKELleY on DSK3SPTVN1PROD with NOTICES
[Docket No. FDA–2013–N–1393]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Patent Term
Restoration, Due Diligence Petitions,
Filing, Format, and Content of
Petitions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
SUMMARY:
VerDate Mar<15>2010
19:20 Nov 13, 2013
Jkt 232001
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 solicits comments on
FDA’s patent term restoration
regulations on due diligence petitions
for regulatory review period revision.
Where a patented product must receive
FDA approval before marketing is
permitted, the Office of Patents and
Trademarks may add a portion of the
FDA review time to the term of a patent.
Petitioners may request reductions in
the regulatory review time if FDA
marketing approval was not pursued
with ‘‘due diligence.’’
DATES: Submit either electronic or
written comments on the collection of
information by January 13, 2014.
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, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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.
Patent Term Restoration, Due Diligence
Petitions, Filing, Format, and Content of
Petitions—21 CFR Part 60 (OMB
Control Number 0910–0233)—Extension
FDA’s patent extension activities are
conducted under the authority of the
Drug Price Competition and Patent
Term Restoration Act of 1984 (21 U.S.C.
355(j)) and the Generic Animal Drug
and Patent Term Restoration Act of 1988
(35 U.S.C. 156). New human drug,
animal drug, human biological, medical
E:\FR\FM\14NON1.SGM
14NON1
]]>Agencies
[Federal Register Volume 78, Number 220 (Thursday, November 14, 2013)]
[Notices]
[Pages 68453-68454]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27222]
-----------------------------------------------------------------------
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 or we) is announcing an
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 January 13, 2014.
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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 301-796-3793, 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 (Pub. L. 103-417)
added section 402(g) of the Federal Food, Drug, and Cosmetic Act (the
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 of our regulations (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. According to 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
[[Page 68454]]
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. The collection of information in Sec. 111.95 has been approved
under OMB Control No. 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:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section; CGMP requirements for dietary supplements Number of responses per Total annual Average burden Total hours
respondents respondent responses per 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: November 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27222 Filed 11-13-13; 8:45 am]
BILLING CODE 4160-01-P
