Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application; Extension, 75635-75636 [2012-30738]
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Federal Register / Vol. 77, No. 246 / Friday, December 21, 2012 / Notices
these programs currently submit all
documentation being requested.
Specifically, all contracting
organizations must submit annual
independently audited financial
statements one time per year. The
MAOs with a net loss, a negative net
worth or both must file three quarterly
statements. Currently there are
approximately 44 MAOs filing quarterly
financial statements. The PDPs must
also file three unaudited quarterly
financial statements. The PACE
organizations are required to file 3
quarterly financial statements for the
first three years in the program.
Additionally, PACE organizations with
a net loss, a negative net worth or both
must file statements as well.
The information collection request is
being revised to include one additional
data element for PACE organizations
only, Total Subordinated Liabilities.
The addition of the new data element
will actually reduce the time to analyze
the financial standing of PACE
organizations because we will no longer
have to contact the PACE organizations
to establish whether or not the
organization’s total liabilities
calculation includes subordinated debt.
Form Number: CMS–906 (OCN: 0938–
0469); Frequency: Annually, Quarterly;
Affected Public: Private Sector: Business
or other for-profits and Not-for-profit
institutions; Number of Respondents:
648; Total Annual Responses: 1,281;
Total Annual Hours: 428. (For policy
questions regarding this collection
contact Joe Esposito at 410–786–1129.
For all other issues call 410–786–1326.)
2. Type of Information Collection
Request: New collection; Title of
Information Collection: Medicare
Enrollment Application for Clinics/
Group Practice and Certain Other
Suppliers; Use: The primary function of
the CMS–855B enrollment application
for Clinics, Group Practices and Certain
Other Suppliers is to gather information
from the organization that tells us what
it is, whether it meets certain
qualifications to be a health care
supplier, where it renders services and
information necessary to establish the
correct claims payment. The goal of
evaluating and revising the CMS–855B
enrollment application is to simplify
and clarify the information collection
without jeopardizing our need to collect
specific information. The majority of the
revisions are very minor in nature such
as spelling and formatting corrections,
removal of duplicate fields and
instruction clarification for the
organization/group. The Sections and
Sub-Sections within the form are also
being re-numbered and re-sequenced to
create a more logical flow of the data
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collection. In addition, CMS is adding a
data collection for an address to mail
the periodic request for the revalidation
of enrollment information (only if it
differs from other addresses currently
collected). Other than the revalidation
mailing address described above, new
data being collected in this revision
package is a checkbox indicating
whether or not an organization is
wholly owned or operated by a hospital,
the inclusion of a new supplier type
(Centralized Flu Biller) and information
on, if applicable, where the supplier
stores its patient records electronically.
While the CMS–855B is not a new form,
this is considered a new information
collection request because we are
submitting it to OMB for approval under
its own OMB control number. Form
Number: CMS–855B (OCN: 0938–New);
Frequency: Yearly; Affected Public:
Individuals and households; Number of
Respondents: 31,000; Total Annual
Responses: 31,000; Total Annual Hours:
103,000 (For policy questions regarding
this collection contact Kim McPhillips
at 410–786–5374. For all other issues
call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on January 22, 2013.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974,
Email: OIRA_submission@omb.eop.gov.
Dated: December 17, 2012.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–30749 Filed 12–20–12; 8:45 am]
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75635
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No.FDA–2012–N–1181]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medicated Feed
Mill License Application; Extension
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 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 February 19, 2013.
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:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PIFO–
410B, Rockville, MD 20850, 301–796–
3794.
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,
SUMMARY:
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75636
Federal Register / Vol. 77, No. 246 / Friday, December 21, 2012 / Notices
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
(ADAA) of October 9, 1996, amended
section 512 of the Federal Food, Drug,
and Cosmetic Act 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR section and activity
Total
annual
responses
Average
burden per
response
Total
hours
Medicated Feed Mill License Application Using Form
FDA 3448 (§ 515.10(b)) ..................................................
Supplemental Feed Mill License Application Using Form
FDA 3448 (§ 515.11(b)) ..................................................
Voluntary Revocation of Medicated Feed Mill License
(§ 515.23) ........................................................................
Filing a Request for a Hearing on Medicated Feed Mill
License (§ 515.30(c)) ......................................................
20
1
20
.25
5
40
1
40
.25
10
40
1
40
.25
10
1
1
1
Total ............................................................................
........................
........................
........................
1 There
4
4
..........................
29
are no capital costs or maintenance costs associated with this information collection.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section
Number of
recordkeepers
Number of
responses per
recordkeeper
Total
annual
records
Average
burden per
recordkeeper
Total
hours
Maintenance of Records for Approved Labeling for Each
‘‘Type B’’ and ‘‘Type C’’ Labeling (§ 510.305) .................
950
1
950
0.03
28.5
mstockstill on DSK4VPTVN1PROD with
1 There
are no capital costs or maintenance costs associated with this information collection.
Estimated annual reporting burden on
industry is 29 hours as shown in table
1. Industry estimates it takes about 15
minutes (.25) to submit the application.
We estimate 100 original and
supplemental applications, and
voluntary revocations for a total of 25
hours (100 submissions × .25 (15
minutes)). An additional 4 hours is
added for the rare notice of opportunity
for a hearing to not approve or revoke
an application. Finally, we estimate 28.5
hours for maintaining and retrieving
labels as required by 21 CFR 510.305.
We estimated .03 hours for each of
approximately 950 licensees. Total
burden for reporting and recordkeeping
would be 57.5 hours.
Dated: December 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–30738 Filed 12–20–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2002–N–0106 (formerly
2002N–0291)]
Baldev Raj Bhutani; Denial of Hearing
on Application for Special Termination
of Debarment
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Notice.
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The Food and Drug
Administration (FDA) is denying Baldev
Raj Bhutani’s application for special
termination of debarment under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act). Mr. Bhutani has failed to
file with the Agency information and
analyses sufficient to create a basis for
a hearing concerning this action.
SUMMARY:
This order is effective December
21, 2012.
DATES:
Comments should reference
Docket No. FDA–2002–N–0106 and be
sent to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
G. Matthew Warren, Office of Scientific
Integrity, Food and Drug
Administration, 10903 New Hampshire
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]]>Agencies
[Federal Register Volume 77, Number 246 (Friday, December 21, 2012)]
[Notices]
[Pages 75635-75636]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30738]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No.FDA-2012-N-1181]
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 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 February 19, 2013.
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: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PIFO-410B,
Rockville, MD 20850, 301-796-3794.
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,
[[Page 75636]]
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 (ADAA) of October 9, 1996, amended
section 512 of the Federal Food, Drug, and Cosmetic Act 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section and activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Medicated Feed Mill License 20 1 20 .25 5
Application Using Form FDA 3448
(Sec. 515.10(b)).............
Supplemental Feed Mill License 40 1 40 .25 10
Application Using Form FDA 3448
(Sec. 515.11(b)).............
Voluntary Revocation of 40 1 40 .25 10
Medicated Feed Mill License
(Sec. 515.23)................
Filing a Request for a Hearing 1 1 1 4 4
on Medicated Feed Mill License
(Sec. 515.30(c)).............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 29
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or maintenance costs associated with this information collection.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of responses per Total annual per Total hours
recordkeepers recordkeeper records recordkeeper
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of Records for Approved Labeling for Each ``Type B'' 950 1 950 0.03 28.5
and ``Type C'' Labeling (Sec. 510.305)..........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or maintenance costs associated with this information collection.
Estimated annual reporting burden on industry is 29 hours as shown
in table 1. Industry estimates it takes about 15 minutes (.25) to
submit the application. We estimate 100 original and supplemental
applications, and voluntary revocations for a total of 25 hours (100
submissions x .25 (15 minutes)). An additional 4 hours is added for the
rare notice of opportunity for a hearing to not approve or revoke an
application. Finally, we estimate 28.5 hours for maintaining and
retrieving labels as required by 21 CFR 510.305. We estimated .03 hours
for each of approximately 950 licensees. Total burden for reporting and
recordkeeping would be 57.5 hours.
Dated: December 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30738 Filed 12-20-12; 8:45 am]
BILLING CODE 4160-01-P
