Agency Information Collection Activities; Proposed Collection; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Extension, 19094-19096 [2014-07708]
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19094
Federal Register / Vol. 79, No. 66 / Monday, April 7, 2014 / Notices
Current Good Manufacturing Practice
Regulations for Type A Medicated
Articles—21 CFR Part 226 (OMB
Control Number 0910–0154)—Extension
Under section 501 of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act), FDA has the statutory
authority to issue current good
manufacturing practice (cGMP)
regulations for drugs, including Type A
medicated articles. A Type A medicated
article is a feed product containing a
concentrated drug diluted with a feed
carrier substance. A Type A medicated
article is intended solely for use in the
manufacture of another Type A
medicated article or a Type B or Type
C medicated feed. Medicated feeds are
administered to animals for the
prevention, cure, mitigation, or
treatment of disease or for growth
promotion and feed efficiency.
Statutory requirements for cGMPs for
Type A medicated articles have been
codified in part 226 (21 CFR part 226).
Type A medicated articles which are not
manufactured in accordance with these
regulations are considered adulterated
under section 501(a)(2)(B) of the FD&C
Act (21 U.S.C. 351(a)(2)(B). Under part
226, a manufacturer is required to
establish, maintain, and retain records
for Type A medicated articles, including
records to document procedures
required under the manufacturing
process to assure that proper quality
control is maintained. Such records
would, for example, contain information
concerning receipt and inventory of
drug components, batch production,
laboratory assay results (i.e., batch and
stability testing), and product
distribution.
This information is needed so that
FDA can monitor drug usage and
possible misformulation of Type A
medicated articles. The information
could also prove useful to FDA in
investigating product defects when a
drug is recalled. In addition, FDA will
use the cGMP criteria in part 226 to
determine whether or not the systems
used by manufacturers of Type A
medicated articles are adequate to
assure that their medicated articles meet
the requirements of the FD&C Act as to
safety and also meet the article’s
claimed identity, strength, quality, and
purity, as required by section
501(a)(2)(B) of the FD&C Act. The
respondents for Type A medicated
articles are pharmaceutical firms that
manufacture both human and veterinary
drugs, those firms that produce only
veterinary drugs, and commercial feed
mills.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section
Number of
records per
recordkeeper
Number of
recordkeepers
Total annual
records
Average burden per recordkeeper
Total hours
226.42 ...................................
226.58 ...................................
226.80 ...................................
226.102 .................................
226.110 .................................
226.115 .................................
65
65
65
65
65
65
260
260
260
260
260
10
16,900
16,900
16,900
16,900
16,900
650
0.75 (45 minutes) ..........................
1.75 (1 hour, 45 minutes) .............
0.75 (45 minutes ...........................
1.75 (1 hour, 45 minutes ..............
0.25 (15 minutes ...........................
0.5 (30 minutes) ............................
12,675
29,575
12,675
29,575
4,225
325
Total ..............................
............................
............................
............................
.......................................................
89,050
1 There
are no capital costs or operating and maintenance costs associated with this collection.
The estimate of time required for
record preparation and maintenance is
based on previous Agency
communications with industry. Other
information needed to calculate the total
burden hours (i.e., manufacturing sites,
number of Type A medicated articles
being manufactured, etc.) are derived
from Agency records and experience.
Dated: March 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0597]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Index of Legally
Marketed Unapproved New Animal
Drugs for Minor Species; Extension
AGENCY:
[FR Doc. 2014–07647 Filed 4–4–14; 8:45 am]
BILLING CODE 4160–01–P
ACTION:
Food and Drug Administration,
HHS.
Notice.
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
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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notice. This notice solicits comments on
the burden hours associated with
indexing of legal marketed unapproved
new animal drugs for minor species.
DATES: Submit either electronic or
written comments on the collection of
information by June 6, 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
E:\FR\FM\07APN1.SGM
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19095
Federal Register / Vol. 79, No. 66 / Monday, April 7, 2014 / Notices
(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.
Index of Legally Marketed Unapproved
New Animal Drugs for Minor Species
21 CFR Part 516 (OMB Control Number
0910–0620)—Extension
Description: The Minor Use and
Minor Species Animal Health Act of
2004 (MUMS Act) amended the Federal
Food, Drug, and Cosmetic Act (the
FD&C 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
(species other than cattle, horses, swine,
chickens, turkeys, dogs, and cats), as
well as uncommon diseases in major
animal species.
The MUMS Act created three new
sections to the FD&C Act (sections 571,
572, and 573), and this final rule
implements section 572, which provides
for an index of legally marketed
unapproved new animal drugs for minor
species. Participation in any part of the
MUMS program is optional so the
associated paperwork only applies to
those who choose to participate. The
final rule specifies, among other things,
the criteria and procedures for
requesting eligibility for indexing and
for requesting addition to the index as
well as the annual reporting
requirements for index holders.
Under subpart C of part 516, § 516.119
provides requirements for naming a
permanent resident U.S. agent by
foreign drug companies, and § 516.121
provides for informational meetings
with FDA. Section 516.123 provides
requirements for requesting informal
conferences regarding Agency
administrative actions and § 516.125
provides for investigational use of new
animal drugs intended for indexing.
Provisions for requesting a
determination of eligibility for indexing
can be found under § 516.129 and
provisions for subsequent requests for
addition to the index can be found
under § 516.145. A description of the
written report required in § 516.145 can
be found under § 516.143. Under
§ 516.141 are provisions for drug
companies to nominate a qualified
expert panel as well as the panel’s
recordkeeping requirements. This
section also calls for the submission of
a written conflict of interest statement to
FDA by each proposed panel member.
Index holders are able to modify their
index listing under § 516.161 or change
drug ownership under § 516.163.
Requirements for records and reports
are under § 516.165.
Description of Respondents:
Pharmaceutical companies that sponsor
new animal drugs. FDA estimates the
burden for this collection of information
as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
516.119
516.121
516.123
516.125
516.129
516.141
516.143
516.145
516.161
516.163
516.165
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
2
30
3
2
30
20
20
20
1
1
10
1
2
1
3
2
1
1
1
1
1
2
2
60
3
6
60
20
20
20
1
1
20
1
4
8
20
20
16
120
20
4
2
8
2
240
24
120
1200
320
2400
400
4
2
160
Total ..............................................................................
........................
........................
........................
........................
4,872
1 There
is no capital or operating and maintenance cost associated with this collection of information.
mstockstill on DSK4VPTVN1PROD with NOTICES
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
516.141 ..............................................................................
516.165 ..............................................................................
30
10
2
2
60
20
2 0.5
1
30
20
Total ............................................................................
........................
........................
........................
........................
50
1 There
2 30
is no capital or operating and maintenance cost associated with this collection of information.
minutes.
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19096
Federal Register / Vol. 79, No. 66 / Monday, April 7, 2014 / Notices
Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07708 Filed 4–4–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0345]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Data To Support
Drug Product Communications as
Used by the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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
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.
FOR FURTHER INFORMATION CONTACT:
Notice.
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
a generic clearance to collect
information to support communications
used by FDA about drug products.
DATES: Submit either electronic or
written comments on the collection of
information by June 6, 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.
SUMMARY:
Data To Support Drug Product
Communications as Used by the Food
and Drug Administration—(OMB
Control Number 0910–0695)—Extension
Testing of communication messages
in advance of a communication
campaign provides an important role in
improving FDA communications as they
allow for an in-depth understanding of
individuals’ attitudes, beliefs,
motivations, and feelings. The methods
to be employed include individual indepth interviews, general public focus
group interviews, intercept interviews,
self-administered surveys, gatekeeper
surveys, and professional clinician
focus group interviews. The methods to
be used serve the narrowly defined need
for direct and informal opinion on a
specific topic and, as a qualitative
research tool, have two major purposes:
(1) To obtain information that is
useful for developing variables and
measures for formulating the basic
objectives of risk communication
campaigns; and
(2) To assess the potential
effectiveness of messages and materials
in reaching and successfully
communicating with their intended
audiences.
FDA will use these methods to test
and refine its ideas and to help develop
messages and other communications but
will generally conduct further research
before making important decisions, such
as adopting new policies and allocating
or redirecting significant resources to
support these policies.
FDA will use this mechanism to test
messages about regulated drug products
on a variety of subjects related to
consumer, patient, or health care
professional perceptions and about use
of drug products and related materials,
including but not limited to, direct-toconsumer prescription drug promotion,
physician labeling of prescription drugs,
Medication Guides, over-the-counter
drug labeling, emerging risk
communications, patient labeling,
online sale of medical products, and
consumer and professional education.
Annually, FDA projects about 45
communication studies using the
variety of test methods listed in this
document. FDA is requesting this
burden so as not to restrict the Agency’s
ability to gather information on public
sentiment for its proposals in its
regulatory and communications
programs.
FDA estimates the burden of this
collection of information as follows:
mstockstill on DSK4VPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Interviews/Surveys .................
19,822
1
19,822
0.24 (14 minutes)
4,757
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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E:\FR\FM\07APN1.SGM
07APN1
]]>Agencies
[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Notices]
[Pages 19094-19096]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07708]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0597]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Index of Legally Marketed Unapproved New Animal Drugs
for Minor Species; Extension
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 the burden hours associated
with indexing of legal marketed unapproved new animal drugs for minor
species.
DATES: Submit either electronic or written comments on the collection
of information by June 6, 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
[[Page 19095]]
(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.
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
21 CFR Part 516 (OMB Control Number 0910-0620)--Extension
Description: The Minor Use and Minor Species Animal Health Act of
2004 (MUMS Act) amended the Federal Food, Drug, and Cosmetic Act (the
FD&C 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 (species
other than cattle, horses, swine, chickens, turkeys, dogs, and cats),
as well as uncommon diseases in major animal species.
The MUMS Act created three new sections to the FD&C Act (sections
571, 572, and 573), and this final rule implements section 572, which
provides for an index of legally marketed unapproved new animal drugs
for minor species. Participation in any part of the MUMS program is
optional so the associated paperwork only applies to those who choose
to participate. The final rule specifies, among other things, the
criteria and procedures for requesting eligibility for indexing and for
requesting addition to the index as well as the annual reporting
requirements for index holders.
Under subpart C of part 516, Sec. 516.119 provides requirements
for naming a permanent resident U.S. agent by foreign drug companies,
and Sec. 516.121 provides for informational meetings with FDA. Section
516.123 provides requirements for requesting informal conferences
regarding Agency administrative actions and Sec. 516.125 provides for
investigational use of new animal drugs intended for indexing.
Provisions for requesting a determination of eligibility for indexing
can be found under Sec. 516.129 and provisions for subsequent requests
for addition to the index can be found under Sec. 516.145. A
description of the written report required in Sec. 516.145 can be
found under Sec. 516.143. Under Sec. 516.141 are provisions for drug
companies to nominate a qualified expert panel as well as the panel's
recordkeeping requirements. This section also calls for the submission
of a written conflict of interest statement to FDA by each proposed
panel member. Index holders are able to modify their index listing
under Sec. 516.161 or change drug ownership under Sec. 516.163.
Requirements for records and reports are under Sec. 516.165.
Description of Respondents: Pharmaceutical companies that sponsor
new animal drugs. FDA estimates the burden for this collection of
information as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
516.119......................... 2 1 2 1 2
516.121......................... 30 2 60 4 240
516.123......................... 3 1 3 8 24
516.125......................... 2 3 6 20 120
516.129......................... 30 2 60 20 1200
516.141......................... 20 1 20 16 320
516.143......................... 20 1 20 120 2400
516.145......................... 20 1 20 20 400
516.161......................... 1 1 1 4 4
516.163......................... 1 1 1 2 2
516.165......................... 10 2 20 8 160
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4,872
----------------------------------------------------------------------------------------------------------------
\1\ There is no capital or operating and maintenance cost associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
516.141........................ 30 2 60 \2\ 0.5 30
516.165........................ 10 2 20 1 20
--------------------------------------------------------------------------------
Total...................... .............. .............. .............. .............. 50
----------------------------------------------------------------------------------------------------------------
\1\ There is no capital or operating and maintenance cost associated with this collection of information.
\2\ 30 minutes.
[[Page 19096]]
Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07708 Filed 4-4-14; 8:45 am]
BILLING CODE 4160-01-P
