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, 42095-42097 [2010-17608]
Download as PDF
<![CDATA[
42095
Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices
when appropriate, and other forms of
information technology.
Designated New Animal Drugs for
Minor Use and Minor Species—21 CFR
Part 516 (OMB Control No. 0910–
0605)—Extension
The Minor Use and Minor Species
(MUMS) Animal Health Act of 2004
amended the Federal Food, Drug, and
Cosmetic Act (the act) to authorize FDA
to establish new regulatory procedures
intended to make more medications
legally available to veterinarians and
animal owners for the treatment of
minor animal species as well as
uncommon diseases in major animal
species. This legislation provides
incentives designed to help
pharmaceutical companies overcome
the financial burdens they face in
providing limited-demand animal
drugs. These incentives are only
available to sponsors whose drugs are
‘‘MUMS-designated’’ by FDA. Minor use
drugs are drugs for use in major species
(cattle, horses, swine, chickens, turkeys,
dogs, and cats) that are needed for
diseases that occur in only a small
number of animals either because they
occur infrequently or in limited
geographic areas. Minor species are all
animals other than the major species, for
example, zoo animals, ornamental fish,
parrots, ferrets, and guinea pigs. Some
animals of agricultural importance are
also minor species. These include
animals such as sheep, goats, catfish,
and honeybees. Participation in the
MUMS program is completely optional
for drug sponsors so the associated
paperwork only applies to those
sponsors who request and are
subsequently granted ‘‘MUMS
designation.’’ The rule specifies the
criteria and procedures for requesting
MUMS designation as well as the
annual reporting requirements for
MUMS designees.
Under part 516 (21 CFR part 516),
§ 516.20 provides requirements on the
content and format of a request for
MUMS-drug designation, § 516.26
provides requirements for amending
MUMS-drug designation, § 516.27
provides provisions for change in
sponsorship of MUMS-drug designation,
§ 516.29 provides provisions for
termination of MUMS-drug designation,
§ 516.30 provides requirements for
annual reports from sponsor(s) of
MUMS-designated drugs, and § 516.36
provides provisions for insufficient
quantities of MUMS-designated drugs.
Respondents are pharmaceutical
companies that sponsor new animal
drugs.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Annual Frequency
per
Response
No. of
Respondents
21 CFR Section
Total Annual
Responses
Hours per
Response
Total Hours
516.20
15
5
75
16
1,200
516.26
3
1
3
2
6
516.27
1
1
1
1
1
516.29
2
1
2
1
2
516.30
15
5
75
2
150
516.36
1
1
1
3
3
Total
1 There
1,362
are no capital costs or operating and maintenance costs associated with this collection of information.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
The burden estimate for this reporting
requirement was derived in FDA’s
Office of Minor Use and Minor Species
Animal Drug Development by
extrapolating the current investigational
new animal drug (INAD) and new
animal drug (NAD) reporting
requirements for similar actions by this
same segment of the regulated industry
and from previous interactions with the
minor use/minor species community.
Dated: July 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0374]
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
[FR Doc. 2010–17609 Filed 7–19–10; 8:45 am]
AGENCY:
BILLING CODE 4160–01–S
HHS.
ACTION:
Food and Drug Administration,
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
VerDate Mar<15>2010
15:23 Jul 19, 2010
Jkt 220001
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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
reporting requirements contained in
existing FDA 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 September 20, 2010.
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
E:\FR\FM\20JYN1.SGM
20JYN1
42096
Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices
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:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
15:23 Jul 19, 2010
Jkt 220001
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
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 act) by
adding section 402(g) of the act (21
U.S.C. 342(g)). Section 402(g)(2) of the
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
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 act (21 U.S.C. 371(a)), FDA
may issue regulations necessary for the
efficient enforcement of the 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
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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
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.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\20JYN1.SGM
20JYN1
42097
Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
Respondents
21 CFR Section
111.75(a)(1)(ii)
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
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: July 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–17608 Filed 7–19–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; NIH Office of Intramural
Training and Education Application
Summary
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, for
opportunity for public comment on
proposed data collection projects, the
Office of Intramural Training &
Education/OIR/OD, the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection
Title: NIH Office of Intramural
Training & Education Application. Type
of Information Collection Request:
Revision. Form Number: 0925–0299.
Expiration Date: September 30, 2012.
Need and Use of Information Collection:
The Office of Intramural Training &
Education (OITE) administers a variety
of programs and initiatives to recruit
pre-college through post-doctoral
educational level individuals into the
National Institutes of Health Intramural
Research Program (NIH–IRP) to facilitate
develop into future biomedical
scientists. The proposed information
collection is necessary in order to
determine the eligibility and quality of
potential awardees for traineeships in
these programs. The applications for
admission consideration include key
areas such as: Personal information,
eligibility criteria, contact information,
student identification number, training
program selection, scientific discipline
interests, educational history,
standardized examination scores,
reference information, resume
components, employment history,
employment interests, dissertation
research details, letters of
recommendation, financial aid history,
sensitive data, future networking
contact, travel information, as well as
feedback questions about interviews and
application submission experiences.
Sensitive data collected on the
applicants, race, gender, ethnicity and
recruitment method, are made available
only to OITE staff members or in
aggregate form to select NIH offices and
are not used by the admission
committee for admission consideration;
optional to submit.
Over the last several years the OITE
has used three OMB Clearance Numbers
for the collection of applications for the
training programs. To improve
announcement of all training programs
and lessen the burden of applicants, the
OITE proposes to merge the following:
• 0925–0299—NIH Intramural
Research Training Award, Program
Application.
• 0925–0438—Undergraduate
Scholarship Program (UGSP).
• 0925–0501—Graduate Student
Training Program Application.
Renewing 0925–0299 OMB Clearance
Number with the new name ‘‘Office of
Intramural Training & Education
Application’’.
Frequency of Response: On occasion.
Affected Public: Individuals seeking
intramural training opportunities and
references for these individuals. Type of
Respondents: students, postbaccalaureates, technicians, graduate
students, and post-doctorates. There are
no capital costs, operating costs, and/or
maintenance costs to report.
The annual reporting burden is
displayed in the following table:
ESTIMATES OF HOUR BURDEN
Estimated
number of respondents
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Program
Estimated
number of responses annually per respondent
Average burden hours per
response
Estimated total
annual burden
hours
8,500
100
2,300
550
125
140
600
2,050
825
300
1,900
1
1
1
1
1
1
1
1
1
1
1
0.75
0.75
0.75
0.75
0.75
0.75
0.75
0.75
0.75
0.75
0.75
6,375.0
75.0
1,725.0
412.5
93.8
105.0
450.0
1,537.5
618.8
225.0
1,425.0
Summer Internship Program in Biomedical Research (SIP) ...........................
Biomedical Engineering Summer Internship Program (BESIP) ......................
Post-baccalaureate Intramural Research Training Award ...............................
NIH Academy ...................................................................................................
Community College Summer Enrichment Program (CCSEP) ........................
Technical Intramural Research Training Award ..............................................
Graduate Partnerships Program (GPP) ...........................................................
Post-Doctorate Fellowship Program ................................................................
National Graduate Student Research Festival (NGSRF) ................................
Undergraduate Scholarship Program (UGSP) ................................................
Alumni Database .............................................................................................
VerDate Mar<15>2010
15:23 Jul 19, 2010
Jkt 220001
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
E:\FR\FM\20JYN1.SGM
20JYN1
]]>Agencies
[Federal Register Volume 75, Number 138 (Tuesday, July 20, 2010)]
[Notices]
[Pages 42095-42097]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17608]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0374]
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
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 solicits comments on reporting requirements
contained in existing FDA 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 September 20, 2010.
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
[[Page 42096]]
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: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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
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
act) by adding section 402(g) of the act (21 U.S.C. 342(g)). Section
402(g)(2) of the 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 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 act (21 U.S.C. 371(a)), FDA may issue regulations necessary for
the efficient enforcement of the 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 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.
FDA estimates the burden of this collection of information as
follows:
[[Page 42097]]
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: July 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17608 Filed 7-19-10; 8:45 am]
BILLING CODE 4160-01-S
