Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet; Form FDA 3601, 52965-52967 [E9-24825]
Download as PDF
<![CDATA[
mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register / Vol. 74, No. 198 / Thursday, October 15, 2009 / Notices
and other entities as part of the
settlement of Federal health care
program fraud investigations arising
under civil and administrative false
claims statutes. These obligations are set
forth in a CIA. A provider or an entity
consents to a CIA in conjunction with
a civil or administrative settlement and
in exchange for OIG’s agreement not to
seek to exclude that health care provider
or entity from participation in Medicare,
Medicaid, and other Federal health care
programs under 42 U.S.C. 1320a–7.
False claims submitted in violation of
the False Claims Act or Civil Monetary
Penalties Law give rise to OIG’s
permissive exclusion authority under 42
U.S.C. 1320a–7(b)(7).
The typical term of a CIA is 5 years.
CIAs seek to ensure the integrity of
Federal health care program claims
submitted by the provider. CIAs
generally include requirements to,
among other things: (1) Hire a
compliance officer; (2) appoint a
compliance committee; (3) develop
written standards and policies; (4)
implement a comprehensive employee
training program; (5) establish a
confidential disclosure program; (6)
restrict employment of ineligible
persons; (7) report overpayments,
reportable events, and ongoing
investigations/legal proceedings; and (8)
provide an implementation report and
annual reports to OIG on the status of
the entity’s compliance activities.
When resolving cases that involve
quality-of-care allegations, OIG often
requires health care providers to enter
into quality-of-care CIAs. OIG may enter
into quality-of-care CIAs with many
different types of health care providers,
including, but not limited to, skilled
nursing facilities, assisted-living
facilities, psychiatric facilities,
intermediate care facilities for the
mentally retarded, hospitals, physician
practices, dental practices, and
management companies. Under these
quality-of-care CIAs, health care
providers agree to compliance
obligations that include quality
assurance and improvement. One such
obligation is to retain an appropriately
qualified monitor, which is appointed
by OIG after consultation with the
health care provider. The monitor
selected contracts directly with the
provider. The monitor does not enter
into any contractual relationship with
OIG or act as an agent for OIG.
The monitor typically is responsible
for assessing the effectiveness,
reliability, and thoroughness of the
provider’s: (1) Internal quality control
systems; (2) response to quality-of-care
issues; (3) development and
implementation of corrective action
VerDate Nov<24>2008
19:13 Oct 14, 2009
Jkt 220001
plans and the timeliness of such actions;
(4) proactive steps to ensure that each
patient receives care in accordance with
basic care, treatment, and protectionfrom-harm standards; the governing
regulations; and the policies and
procedures required to be adopted
under the CIA; and (5) in residential
settings, compliance with staffing
requirements. In making these
assessments, the monitor conducts site
visits, analyzes available data, observes
facility and corporate-level committee
meetings, and reviews relevant
documents. The monitor submits
regular written reports to the provider
and OIG.
Responses to This Notice
OIG is interested in hearing from
organizations that believe they have the
capability to be a monitor for quality-ofcare CIAs. Please include in any
response to this notice the following:
1. The name of the organization;
2. The size and location(s) of the
organization;
3. The qualifications of the
organization to serve as a monitor for
quality-of-care CIAs;
4. The organization’s capacity to
monitor large providers with locations
in multiple States;
5. The organization’s clinical
experience and expertise;
6. The organization’s experience with
quality assessment, assurance, and
improvement;
7. The organization’s prior monitoring
experience, including, but not limited
to, systems reviews and auditing; and
8. An indication of whether the
organization has any current or prior
(within the last 5 years) Federal
Government contracts or is on any
General Services Administration or HHS
list of approved contractors.
OIG will review each response
submitted to this notice to assess
whether the organization may be
appropriate to serve as a monitor for
quality-of-care CIAs. The assessment
will not be for the purpose of making
any definitive determination regarding
whether a particular organization is
qualified to be a monitor or creating a
list of pre-approved monitors. Factors
that OIG considers when assessing
whether an organization may be an
appropriate monitor for a particular CIA
include, among other things, the
organization’s clinical expertise,
capacity to handle a particular
monitoring relationship, quality
monitoring experience, geographic
location, and independence and
objectivity. Each provider and qualityof-care CIA is unique. Accordingly, the
selection of an appropriate monitor for
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
52965
any given quality-of-care CIA requires
consideration of unique and
individualized factors. In order to select
an appropriate monitor for any
individual quality-of-care CIA, OIG may
contact an organization that submitted
information in response to this notice to
request additional information. In
selecting a monitor, OIG will not be
limited to organizations that submitted
information in response to this notice.
Any organization submitting
information in response to this notice
should identify any information that it
believes is trade secret, or commercial
or financial information, and privileged
or confidential under exemption four of
the Freedom of Information Act (FOIA).
Consistent with the HHS FOIA
regulations, set forth in 45 CFR Part 5,
when OIG receives a request for such
records and OIG determines that OIG
may be required to disclose them, OIG
will make reasonable efforts to notify
the organization about these facts.
Daniel R. Levinson,
Inspector General.
[FR Doc. E9–24715 Filed 10–14–09; 8:45 am]
BILLING CODE 4152–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0483]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
User Fee Cover Sheet; Form FDA 3601
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
Form FDA 3601 entitled ‘‘Medical
Device User Fee Cover Sheet,’’ which
must be submitted along with certain
medical device product applications,
supplements, and fee payment of those
applications.
E:\FR\FM\15OCN1.SGM
15OCN1
52966
Federal Register / Vol. 74, No. 198 / Thursday, October 15, 2009 / Notices
DATES: Submit written or electronic
comments on the collection of
information by December 14, 2009.
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:
Denver Presley Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 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.
Medical Device User Fee Cover Sheet;
Form FDA 3601 (OMB Control Number
0910–0511)–Extension
The Federal Food, Drug, and Cosmetic
Act (the act), as amended by the
Medical Device User Fee and
Modernization Act of 2002 (Public Law
107–250), and the Medical Device User
Fee Amendments of 2007 (Title II of the
Food and Drug Administration
Amendments Act of 2007), authorizes
FDA to collect user fees for certain
medical device applications. Under this
authority, companies pay a fee for
certain new medical device applications
or supplements submitted to the agency
for review. Because the submission of
user fees concurrently with applications
and supplements is required, the review
of an application cannot begin until the
fee is submitted. Form FDA 3601, the
‘‘Medical Device User Fee Cover Sheet,’’
is designed to provide the minimum
necessary information to determine
whether a fee is required for review of
an application, to determine the amount
of the fee required, and to account for
and track user fees. The form provides
a cross-reference between the fees
submitted for an application with the
actual submitted application by using a
unique number tracking system. The
information collected is used by FDA’s
Center for Devices and Radiological
Health (CDRH) and the Center for
Biologics Evaluation and Research
(CBER) to initiate the administrative
screening of new medical device
applications and supplemental
applications.
The total number of annual responses
is based on the number of cover sheet
submissions received by FDA in fiscal
year (FY) 2008. CDRH received
approximately 5,095 annual responses
that included the following
submissions: 16 premarket approval
applications (PMA) (PMA, PDP, PMR,
BLA),1 3,625 premarket notifications, 8
modular premarket applications, 9
panel track supplements, 201 real-time
supplements, 173 one hundred eightyday supplements, 633 thirty-day
notices, ninety-three 513(g) requests,
and 337 annual fees for periodic
reporting.
CBER received approximately 97
annual responses that included the
following submissions: 2 premarket
approval applications (PMA, PDP, PMR,
BLA), 1 BLA efficacy supplement, 50
premarket notifications, 3 one hundred
eighty-day supplements, 2 real-time
supplements, 20 thirty-day notices,
3hree 513(g) requests, and 16 annual
fees for periodic reporting.
The number of received annual
responses in FY 2008 included the
cover sheets for applications that were
qualified for small businesses and fee
waivers or reductions. The estimated
hours per response are based on past
FDA experience with the various cover
sheet submissions, and range from 5 to
30 minutes. The hours per response are
based on the average of these estimates.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Form FDA No.
3601
Annual Frequency
per Response
5,192
1
Total Annual
Responses
Hours per
Response
5,192
.30
Total Hours
mstockstill on DSKH9S0YB1PROD with NOTICES
1There
1,557.6
1,557.6
are no capital costs or operating and maintenance costs associated with this collection of information.
1 PDP means product development protocol; PMR
means postmarketing requirements; and BLA means
biologics license applications.
VerDate Nov<24>2008
Total Hours
19:13 Oct 14, 2009
Jkt 220001
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
E:\FR\FM\15OCN1.SGM
15OCN1
Federal Register / Vol. 74, No. 198 / Thursday, October 15, 2009 / Notices
Dated: October 7, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–24825 Filed 10–14–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0488]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Records and
Reports Concerning Experience With
Approved New Animal Drugs; Adverse
Event Reports on Forms FDA 1932,
1932a, and 2301
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSKH9S0YB1PROD with NOTICES
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
requirements for recordkeeping and
reports concerning experience with
approved new animal drugs. The
information contained in the reports
required by the regulation enables FDA
to monitor the use of new animal drugs
after approval and to ensure their
continued safety and efficacy.
DATES: Submit written or electronic
comments on the collection of
information by December 14, 2009.
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:
Denver Presley Jr, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
VerDate Nov<24>2008
19:13 Oct 14, 2009
Jkt 220001
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.
SUPPLEMENTARY INFORMATION:
Records and Reports Concerning
Experience With Approved New
Animal Drugs; Adverse Event Reports
on Forms FDA 1932, 1932a, and 2301—
21 CFR Section 514.80 (OMB No. 0910–
0284)—Extension
Sections 512(l) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360b(l)) and § 514.80 (21 CFR
514.80) of FDA regulations require
applicants of approved new animal drug
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) to report adverse drug
experiences and product/manufacturing
defects (see § 514.80(b)).
This continuous monitoring of
approved NADAs and ANADAs affords
the primary means by which FDA
obtains information regarding potential
problems with the safety and efficacy of
marketed approved new animal drugs as
well as potential product/manufacturing
problems. Postapproval marketing
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
52967
surveillance is important because data
previously submitted to FDA may not be
adequate, as animal drug effects can
change over time and less apparent
effects may take years to manifest.
Under § 514.80(d), an applicant must
report adverse drug experiences and
product/manufacturing defects on Form
FDA 1932, ‘‘Veterinary Adverse Drug
Reaction, Lack of Effectiveness, Product
Defect Report.’’ Periodic drug
experience reports and special drug
experience reports must be
accompanied by a completed Form FDA
2301, ‘‘Transmittal of Periodic Reports
and Promotional Material for New
Animal Drugs’’ (see § 514.80(d)). Form
FDA 1932a, ‘‘Veterinary Adverse Drug
Reaction, Lack of Effectiveness or
Product Defect Report’’ allows for
voluntary reporting of adverse drug
experiences or product/manufacturing
defects.
The electronic versions of Forms FDA
1932 and 1932a have been incorporated
into the agency-wide information
collection (MedWatchPlus Portal and
Rational Questionnaire) that was
announced for public comment in the
Federal Register of October 23, 2008 (73
FR 63153). MedWatchPlus Portal and
Rational Questionnaire is part of a new
electronic system for collecting,
submitting, and processing adverse
event reports and other safety
information for all FDA-regulated
products. In the Federal Register of May
20, 2009 (74 FR 23721), FDA announced
the submission for OMB review and
clearance of the electronic data
collection using MedWatchPlus Portal
and Rational Questionnaire.
Burden hours for the electronic
versions of these forms were included as
part of the MedWatchPlus Portal and
Rationale Questionnaire information
collection approved under OMB control
number 0910–0645. It is estimated that,
during the first 3 years that the
MedWatchPlus Portal is in use, half of
the reports will be submitted in paper
format and half will be submitted
electronically. In order to avoid double
counting, an estimated 50 percent of
total annual responses for FDA Form
1932 (404) and FDA Form 1932a (81.5)
are counted here as part of OMB control
number 0910–0284 for the paper
versions of Forms FDA 1932 and 1932a,
and an estimated 50 percent of the total
annual responses (404) and (81.5) for
Form FDA 1932 and FDA Form 1932a
respectively, are counted as part of OMB
control number 0910–0645 for the
electronic reporting of these adverse
reports using the MedWatchPlus Portal.
The paper versions of Forms FDA
1932 and 1932a, as well as Form FDA
E:\FR\FM\15OCN1.SGM
15OCN1
]]>Agencies
[Federal Register Volume 74, Number 198 (Thursday, October 15, 2009)]
[Notices]
[Pages 52965-52967]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24825]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0483]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device User Fee Cover Sheet; Form FDA 3601
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 Form FDA 3601 entitled
``Medical Device User Fee Cover Sheet,'' which must be submitted along
with certain medical device product applications, supplements, and fee
payment of those applications.
[[Page 52966]]
DATES: Submit written or electronic comments on the collection of
information by December 14, 2009.
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: Denver Presley Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 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.
Medical Device User Fee Cover Sheet; Form FDA 3601 (OMB Control Number
0910-0511)-Extension
The Federal Food, Drug, and Cosmetic Act (the act), as amended by
the Medical Device User Fee and Modernization Act of 2002 (Public Law
107-250), and the Medical Device User Fee Amendments of 2007 (Title II
of the Food and Drug Administration Amendments Act of 2007), authorizes
FDA to collect user fees for certain medical device applications. Under
this authority, companies pay a fee for certain new medical device
applications or supplements submitted to the agency for review. Because
the submission of user fees concurrently with applications and
supplements is required, the review of an application cannot begin
until the fee is submitted. Form FDA 3601, the ``Medical Device User
Fee Cover Sheet,'' is designed to provide the minimum necessary
information to determine whether a fee is required for review of an
application, to determine the amount of the fee required, and to
account for and track user fees. The form provides a cross-reference
between the fees submitted for an application with the actual submitted
application by using a unique number tracking system. The information
collected is used by FDA's Center for Devices and Radiological Health
(CDRH) and the Center for Biologics Evaluation and Research (CBER) to
initiate the administrative screening of new medical device
applications and supplemental applications.
The total number of annual responses is based on the number of
cover sheet submissions received by FDA in fiscal year (FY) 2008. CDRH
received approximately 5,095 annual responses that included the
following submissions: 16 premarket approval applications (PMA) (PMA,
PDP, PMR, BLA),\1\ 3,625 premarket notifications, 8 modular premarket
applications, 9 panel track supplements, 201 real-time supplements, 173
one hundred eighty-day supplements, 633 thirty-day notices, ninety-
three 513(g) requests, and 337 annual fees for periodic reporting.
---------------------------------------------------------------------------
\1\ PDP means product development protocol; PMR means
postmarketing requirements; and BLA means biologics license
applications.
---------------------------------------------------------------------------
CBER received approximately 97 annual responses that included the
following submissions: 2 premarket approval applications (PMA, PDP,
PMR, BLA), 1 BLA efficacy supplement, 50 premarket notifications, 3 one
hundred eighty-day supplements, 2 real-time supplements, 20 thirty-day
notices, 3hree 513(g) requests, and 16 annual fees for periodic
reporting.
The number of received annual responses in FY 2008 included the
cover sheets for applications that were qualified for small businesses
and fee waivers or reductions. The estimated hours per response are
based on past FDA experience with the various cover sheet submissions,
and range from 5 to 30 minutes. The hours per response are based on the
average of these estimates. FDA estimates the burden of this collection
of information as follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Form FDA No. Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
3601 5,192 1 5,192 .30 1,557.6
----------------------------------------------------------------------------------------------------------------
Total Hours 1,557.6
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 52967]]
Dated: October 7, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24825 Filed 10-14-09; 8:45 am]
BILLING CODE 4160-01-S
