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, 29716-29717 [2015-12398]
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29716
Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices
Commonwealth of Puerto Rico, and U.S.
territories applying for CSBG funds to
submit an application and plan (Model
State Plan). The Model State Plan must
meet statutory requirements prior to
being funded with CSBG funds.
Applicants have the option to submit a
detailed plan annually or biannually.
Entities that submit a biannual plan
must provide an abbreviated plan the
following year if substantial changes to
the initial plan will occur.
This request is to revise the Model
State Plan format for States by
automating the form, streamlining the
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Community Services Block
Grant (CSBG) Model State Plan.
OMB No.: 0970–0382.
Description: Section 676 of the
Community Services Block Grant
(CSBG) Act requires States, including
the District of Columbia and the
information, and incorporating
accountability measures. The revised
and automated form may impose an
added first-use burden; however, this
burden will diminish substantially in
subsequent years. Copies of the
proposed collection of information/
Model State Plan can be obtained by
visiting https://www.acf.hhs.gov/
programs/ocs/programs/csbg.
Respondents: State Governments,
including the District of Columbia and
the Commonwealth of Puerto Rico, and
U.S. territories.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Model State Plan .............................................................................................
56
1
33
1,848
Estimated Total Annual Burden
Hours: 1,848.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
in brackets in the heading of this
document.
Additional Information
Food and Drug Administration
FOR FURTHER INFORMATION CONTACT:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment
asabaliauskas on DSK5VPTVN1PROD with NOTICES
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–12392 Filed 5–21–15; 8:45 am]
BILLING CODE 4184–01–P
VerDate Sep<11>2014
18:19 May 21, 2015
Jkt 235001
[Docket No. FDA–2013–N–1152]
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 June 22,
2015.
SUMMARY:
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
ADDRESSES:
PO 00000
Frm 00115
Fmt 4703
Sfmt 4703
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Road, COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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)—
Reinstatement
The Dietary Supplement Health and
Education Act (DSHEA) (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.
E:\FR\FM\22MYN1.SGM
22MYN1
29717
Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices
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) (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-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 § 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. 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.
In the Federal Register of March 9,
2015 (80 FR 12491), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was
received, but was not responsive to the
four collection of information topics
solicited in the notice and, therefore, is
not discussed in this document.
We estimate the annual 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
asabaliauskas on DSK5VPTVN1PROD with NOTICES
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.
VerDate Sep<11>2014
18:19 May 21, 2015
Jkt 235001
Dated: May 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–12398 Filed 5–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Pharmacy Compounding Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pharmacy
Compounding Advisory Committee.
PO 00000
Frm 00116
Fmt 4703
Sfmt 4703
General Function of the Committee:
To provide advice on scientific,
technical, and medical issues
concerning drug compounding under
sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act), and, as required, any other product
for which FDA has regulatory
responsibility, and make appropriate
recommendations to the Commissioner
of Food and Drugs.
Date and Time: The meeting will be
held on June 17, 2015, from 8:30 a.m.
to 5 p.m., and on June 18, 2015, from
8:30 a.m. to 11:30 a.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
E:\FR\FM\22MYN1.SGM
22MYN1
]]>Agencies
[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29716-29717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12398]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1152]
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 June
22, 2015.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Road, COLE-14526, Silver
Spring, MD 20993-0002, 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)--
Reinstatement
The Dietary Supplement Health and Education Act (DSHEA) (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.
[[Page 29717]]
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) (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. 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.
In the Federal Register of March 9, 2015 (80 FR 12491), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received, but was not
responsive to the four collection of information topics solicited in
the notice and, therefore, is not discussed in this document.
We estimate the annual 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: May 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12398 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P
