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, 60463-60464 [2010-24642]
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60463
Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
hospitals
Form name
Focus groups at intervention sites ..................................................................
Focus groups at control sites ..........................................................................
ASP Questionnaire ..........................................................................................
Total ..........................................................................................................
* The hourly wage for the focus
groups is based upon the mean of the
average wages for physicians ($79.33),
pharmacists ($50.13), and medical and
health services managers ($42.67). The
hourly wage for the surveys is based
upon the average wages for physicians
($79.33) and pharmacists ($50.13).
These data come from the May 2008
National Occupational Employment and
Wage Estimates, United States,—U.S.
Total burden
hours
6
5
11
22
Bureau of Labor Statistics Division of
Occupational Employment Statistics,
May 2008, National Occupational
Employment and Wage Estimates,
https://www.bls.gov/oes/2008/may/
oes_nat.htmb#11-0000.
Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the annualized and
total cost to the federal government for
Average hourly wage rate*
Total cost burden
$57.38
57.38
64.73
n/a
$2,066
1,320
11,651
15,037
36
23
180
239
this two year research project. Project
Management includes activities related
to coordination between BUSPH staff,
contracted staff at MMC and GNYIIA,
and monthly phone calls with the task
order officer. Project development
covers steps taken to revise the research
plan and begin implementation. The
total cost is estimated to be $999,995.
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST TO THE GOVERNMENT
Annualized
cost
Cost component
Project Management ................................................................................................................................................
Project Development ...............................................................................................................................................
Data Collection and Analysis ...................................................................................................................................
Technical Assistance and Consultation ...................................................................................................................
Confirmatory lab testing ...........................................................................................................................................
Travel .......................................................................................................................................................................
Project Supplies and materials ................................................................................................................................
Overhead .................................................................................................................................................................
Total ..................................................................................................................................................................
mstockstill on DSKH9S0YB1PROD with NOTICES6
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ healthcare research and
healthcare information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
VerDate Mar<15>2010
17:48 Sep 29, 2010
Jkt 220001
Dated: September 17, 2010.
Carolyn M. Clancy,
Director.
$28,315
84,944
169,888
60,750
20,000
7,500
2,450
126,395
499,998
Total cost
$56,629
169,400
339,776
121,500
40,000
15,000
4,900
252,790
999,995
[FR Doc. 2010–24423 Filed 9–29–10; 8:45 am]
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
BILLING CODE 4160–90–M
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ADDRESSES:
Food and Drug Administration
[Docket No. FDA–2010–N–0374]
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
SUMMARY:
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
Fax written comments on the
collection of information by November
1, 2010.
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:
Denver Presley Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
E:\FR\FM\30SEN1.SGM
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60464
Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices
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—(OMB Control Number
0910–0608)—Extension
On October 25, 1994, the Dietary
Supplement Health and Education Act
(DSHEA) (Public Law 103–417) was
signed into law. DSHEA, among other
things, amended the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
by adding section 402(g) of the FD&C
Act (21 U.S.C. 342(g)). Section 402(g)(2)
of the FD&C Act 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.’’ Under section 701(a) of the
FD&C Act (21 U.S.C. 371(a)), FDA may
issue regulations necessary for the
efficient enforcement of the FD&C Act.
FDA published a final rule on June
25, 2007 (72 FR 34752) (the final rule)
that established, in part 111 (21 CFR
part 111), 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.
On June 25, 2007 (72 FR 34959), FDA
also published an Interim Final Rule
(the IFR) establishing a procedure for a
petition to request an exemption from
100 percent identity testing of dietary
ingredients. The IFR redesignated
§ 111.75(a)(1) of the CGMP final rule as
§ 111.75(a)(1)(i) and set forth a
procedure for submission of a petition
to FDA in a new § 111.75(a)(1)(ii), under
which 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
FDA is 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) of the CGMP final
rule reflects FDA’s 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, FDA recognizes 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, FDA 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 and the
agency grants such exemption. Such a
procedure would be consistent with
FDA’s 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
the FDA’s 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 July 20,
2010 (75 FR 42095) FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
Number of
Respondents
111.75(a)(1)(ii)
mstockstill on DSKH9S0YB1PROD with NOTICES6
1 There
Annual Frequency
per Response
1
Total Annual
Responses
1
Hours per
Response
1
Total Hours
8
8
are no capital costs or operating and maintenance costs associated with this collection of information.
In the last 3 years, FDA has 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.
Although FDA has not received any new
petitions to request an exemption from
100 percent identity testing of dietary
ingredients in the last 3 years, it
believes that 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
VerDate Mar<15>2010
17:48 Sep 29, 2010
Jkt 220001
exemption from 100 percent identity
testing of dietary ingredients. Based on
our experience with petition processes,
we estimate that the assembly of
information in support of the petition
required by § 111.75(a)(1)(ii) will take 8
hours.
Dated: September 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–24642 Filed 9–29–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Notice of Meeting
In accordance with section 10(d) of
the Federal Advisory Committee Act (5
U.S.C., Appendix 2), announcement is
made of a Health Care Policy and
Research Special Emphasis Panel (SEP)
meeting.
A Special Emphasis Panel is a group
of experts in fields related to health care
E:\FR\FM\30SEN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 189 (Thursday, September 30, 2010)]
[Notices]
[Pages 60463-60464]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24642]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0374]
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
November 1, 2010.
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: Denver Presley Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed
[[Page 60464]]
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--(OMB Control Number 0910-0608)--Extension
On October 25, 1994, the Dietary Supplement Health and Education
Act (DSHEA) (Public Law 103-417) was signed into law. DSHEA, among
other things, amended the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)).
Section 402(g)(2) of the FD&C Act 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.''
Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA may issue
regulations necessary for the efficient enforcement of the FD&C Act.
FDA published a final rule on June 25, 2007 (72 FR 34752) (the
final rule) that established, in part 111 (21 CFR part 111), 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. On
June 25, 2007 (72 FR 34959), FDA also published an Interim Final Rule
(the IFR) establishing a procedure for a petition to request an
exemption from 100 percent identity testing of dietary ingredients. The
IFR redesignated Sec. 111.75(a)(1) of the CGMP final rule as Sec.
111.75(a)(1)(i) and set forth a procedure for submission of a petition
to FDA in a new Sec. 111.75(a)(1)(ii), under which 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 FDA is 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) of the CGMP final rule reflects FDA's
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, FDA recognizes 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, FDA 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 and the
agency grants such exemption. Such a procedure would be consistent with
FDA's 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 the FDA's 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 July 20, 2010 (75 FR 42095) FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses 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, FDA has 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. Although FDA has not received any
new petitions to request an exemption from 100 percent identity testing
of dietary ingredients in the last 3 years, it believes that 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. Based on our experience with petition processes, we
estimate that the assembly of information in support of the petition
required by Sec. 111.75(a)(1)(ii) will take 8 hours.
Dated: September 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24642 Filed 9-29-10; 8:45 am]
BILLING CODE 4160-01-S
