Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application-Extension, 50433-50434 [E6-14076]
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Federal Register / Vol. 71, No. 165 / Friday, August 25, 2006 / Notices
Authority: Section 1811 and 1831 of the
Social Security Act (42 U.S.C. 1395c and
1395j).
(Catalog of Federal Domestic Assistance
Program No. 93.774, Medicare—
Supplementary Medical Insurance Program)
Submit written or electronic
comments on the collection of
information by October 24, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1472.
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
DATES:
Dated: August 3, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. E6–13379 Filed 8–24–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0329]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medicated Feed
Mill License Application—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 medicated feed mill licensing
system.
50433
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.
Medicated Feed Mill Licensing
Application—21 CFR Part 515 (OMB
Control Number 0910–0337)—Extension
The Animal Drug Availability Act of
1996 (ADAA), amended section 512 of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360b) to replace the
system for the approval of specific
medicated feed with a general licensing
system for feed mills. Before passage of
the ADAA, medicated feed
manufacturers were required to obtain
approval of medicated feed applications
(MFAs) in order to manufacture certain
types of medicated feeds. An individual
approved MFA was required for each
and every applicable medicated feed.
The ADAA streamlined the paperwork
process for gaining approval to
manufacture medicated feeds by
replacing the MFA system with a
facility license for each medicated feed
manufacturing facility. Implementing
regulations are at 21 CFR part 515.
Respondents are expected to be
medicated feed manufacturers.
FDA estimates the burden for this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
515.10(b)
7
1
7
0.25
515.11(b)
100
1
100
0.25
25
1
25
0.25
515.23
515.30(c)
0.15
1
0.15
24
cprice-sewell on PROD1PC66 with NOTICES
Total Burden Hours
1There
14:57 Aug 24, 2006
25
6.25
3.6
36.6
are no capital costs or operating and maintenance costs associated with this collection of information.
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1.75
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25AUN1
50434
Federal Register / Vol. 71, No. 165 / Friday, August 25, 2006 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
510.305
1There
1,070
Dated: August 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–14076 Filed 8–24–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
National Center for Natural Products
Research, University of Mississippi;
Single Source Cooperative Agreement;
Catalog of Federal Domestic
Assistance Number 93.103; Request
for Application
AGENCY:
Food and Drug Administration,
HHS.
Notice.
I. Funding Opportunity Description
cprice-sewell on PROD1PC66 with NOTICES
Total Annual
Records
1
Hours per
Record
1,070
Total Hours
0.03
32.10
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated annual reporting
burden on industry is 36.6 hours, as
shown in table 1 of this document.
Industry estimates it takes about 0.25
hours to submit the application. We
estimate 132 original and supplemental
applications and voluntary revocations
for a total of 33 hours (132 submissions
x 0.25 hours). An additional 3.6 hours
are added for the rare notice of
opportunity for a hearing to not approve
or revoke an application. Finally, we
estimate 36 hours for maintaining and
retrieving labels as required by 21 CFR
510.305. We estimated .03 hours for
each of approximately 1,070 licensees.
Thus, the total burden for recordkeeping
requirements is 32.10 hours (1,070
licensees x 0.03 hours).
ACTION:
Annual Frequency
per Recordkeeping
The Food and Drug Administration
(FDA) is announcing its intention to
receive and consider a single source
competing continuation application for
the award of a cooperative agreement in
fiscal year (FY 2006) to the University
of Mississippi (UM) to support the
National Center for Natural Products
Research (NCNPR), which is located on
UM’s Campus at Oxford, MS, for up to
$2.3 million for FY06 (direct plus
indirect costs combined), the total
amount being subject to annual budget
appropriations. The funds will provide
additional support to the UM’s NCNPR
for the purpose of promoting more
VerDate Aug<31>2005
14:57 Aug 24, 2006
Jkt 208001
efficient development and
dissemination of natural products
research and science and will
complement the diverse activities of
both the public and private sectors that
may become collaborators.
Subject to the availability of Federal
funds and successful performance, 4
additional years of support will be
available. FDA will support the research
covered by this notice under the
authority of section 301 of the Public
Health Service (PHS) Act (42 U.S.C.
241). FDA’s research program is
described in the Catalog of Federal
Domestic Assistance No.93.103. Before
entering into cooperative agreements,
FDA carefully considers the benefits
such agreements will provide to the
public.
II. Eligibility Information
FDA believes that there is compelling
evidence that UM is uniquely qualified
to fulfill the objectives of the proposed
cooperative agreement. UM is a
comprehensive research institution with
numerous academic programs relevant
to FDA’s mission and the resources to
support the Center for Food Safety and
Nutrition’s (CFSAN’s) areas of interest.
NCNPR, which opened in July 1995,
is a division of the Research Institute of
Pharmaceutical Sciences of UM’s
School of Pharmacy. NCNPR was
created to bring together an alliance of
academia, government, and industry to
integrate research, development, and
commercialization of potentially useful
natural products.
The goal of NCNPR in botanical
dietary supplements is to enable safe,
effective, and proper use of high quality
botanical products by informed
professionals and consumers. NCNPR
conducts basic and applied
multidisciplinary research to discover
and develop natural products for use as
dietary supplements. NCNPR also
maintains a repository of several
thousand natural product extracts that
are available for screening by
collaborators working in other areas.
NCNPR has substantial expertise to
carry forward specific discoveries,
products, and technologies. Most of the
projects to develop promising high
priority products or technology are
conducted in collaboration with
industrial partners or through externally
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
funded grants and contract. NCNPR is
staffed with a highly synergistic mix of
full-time research faculty and support
staff and employs a number of
undergraduate and graduate students
and postdoctoral scientists. Together,
the faculty, scientists, staff, students,
and external collaborators, provide the
human resources required to
accomplish the research and
development goals of NCNPR.
Collaboration between the public and
private sector is an efficient means for
both FDA and the University to remain
current with scientific and technical
accomplishments from a natural
products research perspective.
Harmonizing research activities is but
one example of the need for and use of
this natural products research
knowledge and expertise. The
partnership between FDA and UM will
provide both the technical and
educational expertise necessary for
effective mechanisms that will facilitate
the movement of new technology and
provide direct usefulness to FDA’s
scientific and enforcement initiatives.
As of October 1, 2003, applicants are
required to have a Dun and Bradstreet
Number (DUNS) to apply for a grant or
cooperative agreement from the Federal
Government. The DUNS number is a 9digit identification number, which
uniquely identifies business entities.
Obtaining a DUNS number is easy and
there is no charge. To obtain a DUNS
number, applicants should go to https://
www.grants.gov/RequestaDUNS or call
1–866–705–5711. (FDA has verified the
Web site address, but FDA is not
responsible for any subsequent changes
to the Web site after this document
publishes in the Federal Register.)
III. Application and Submission
To comply with the President’s
Management Agenda, HHS is
participating as a partner in the new
government-wide Grants.gov Web site.
Users of Grants.gov will be able to
download a copy of the application
package, complete it offline, and then
upload and submit the application via
the Grants.gov Web site. We encourage
applicant submission through
Grants.gov. If submitted other than
electronically, please contact Gladys M.
Bohler for guidance (see contact
E:\FR\FM\25AUN1.SGM
25AUN1
]]>Agencies
[Federal Register Volume 71, Number 165 (Friday, August 25, 2006)]
[Notices]
[Pages 50433-50434]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14076]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0329]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medicated Feed Mill License Application--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 medicated feed mill
licensing system.
DATES: Submit written or electronic comments on the collection of
information by October 24, 2006.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1472.
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.
Medicated Feed Mill Licensing Application--21 CFR Part 515 (OMB Control
Number 0910-0337)--Extension
The Animal Drug Availability Act of 1996 (ADAA), amended section
512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) to
replace the system for the approval of specific medicated feed with a
general licensing system for feed mills. Before passage of the ADAA,
medicated feed manufacturers were required to obtain approval of
medicated feed applications (MFAs) in order to manufacture certain
types of medicated feeds. An individual approved MFA was required for
each and every applicable medicated feed. The ADAA streamlined the
paperwork process for gaining approval to manufacture medicated feeds
by replacing the MFA system with a facility license for each medicated
feed manufacturing facility. Implementing regulations are at 21 CFR
part 515.
Respondents are expected to be medicated feed manufacturers.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
515.10(b) 7 1 7 0.25 1.75
--------------------------------------------------------------------------------------------------------------------------------------------------------
515.11(b) 100 1 100 0.25 25
--------------------------------------------------------------------------------------------------------------------------------------------------------
515.23 25 1 25 0.25 6.25
--------------------------------------------------------------------------------------------------------------------------------------------------------
515.30(c) 0.15 1 0.15 24 3.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Burden Hours 36.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 50434]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
510.305 1,070 1 1,070 0.03 32.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated annual reporting burden on industry is 36.6 hours, as
shown in table 1 of this document. Industry estimates it takes about
0.25 hours to submit the application. We estimate 132 original and
supplemental applications and voluntary revocations for a total of 33
hours (132 submissions x 0.25 hours). An additional 3.6 hours are added
for the rare notice of opportunity for a hearing to not approve or
revoke an application. Finally, we estimate 36 hours for maintaining
and retrieving labels as required by 21 CFR 510.305. We estimated .03
hours for each of approximately 1,070 licensees. Thus, the total burden
for recordkeeping requirements is 32.10 hours (1,070 licensees x 0.03
hours).
Dated: August 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-14076 Filed 8-24-06; 8:45 am]
BILLING CODE 4160-01-S
